Tuesday, 23 June 2020

Iris Publishers_World Journal of Gynecology & Womens Health (WJGWH)

Value of Neutrophil Lymphocytic Ratio and Platelet Lymphocytic Ratio in Premature Rupture of Membranes for Detection of Subclinical Chorioamnoitis

Amniotic membrane, which is considered as a closed envelope around the fetus, is the most important barrier for protecting fetus from exterior , and the contained amniotic fluid gives the fetus the space to move and a media for excretion and also nutrion [1], Amniotic sac should remain intact till near the end of second stage of labour , Any break in the sac before that should be considered as a premature rupture of membrane (PROM), if it occurred before 36 weeks gestation it will be considered as preterm premature rupture of membranes [2].

The second most common cause of preterm labour is preterm PROM , as rupture of membranes will lead to local release of inflammatory mediators which in turn lead to premature uterine contractions that may end to preterm labour with its all hazards to the fetus [3]. But the most dangerous and most important concern about preterm PROM is the occurrence of chorioamnoitis [4]. Chorioamnoitis is inflammation of fetal membranes and mayproceed to underlying decidua, it may lead to maternal toxemia and even septic shock, with very bad fetal outcome [5]. Occurrence of chorioamnoitis should be excluded in every case suffering from PROM , as it has dangerous consequences , and also may affect the course of labour when decision of labour is taken, as the uterus may not respond efficiently to uterotonic drugs in case of vaginal delivery that lead to increase rate of cesarean section , which also may complicated with surgical infection with all its hazards , with increase susceptibility to atonic postpartum hemorrhage [6]. Diagnosis of subclinical infection in case of PROM is a medical challenge. The most important and widely used markers are CRP and TLC , both had accepted specificity but low sensitivity making its use alone had many disadvantages and many misdiagnosed cases [7]. Neutrophil lymphocytic ratio (N/L) and platelet lymphocytic ratio (P/L) had been suggested to be used as alternative markers [8].


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Tuesday, 16 June 2020

Iris Publishers_World Journal of Gynecology & Womens Health (WJGWH)

Endometriosis as a Risk Factor for Colorectal Cancer

Abstract

Endometriosis is a common benign disease in women of reproductive age, it has been associated with an increased risk of various malignancies that is defined by certain histological criteria mainly 80% in ovary and 20% in extragonadal sites such as intestine, rectovaginal septum, abdominal wall , pleura and others; the greatest risk for colorectal cancer is women with adenomyosis or endometriosis; Several genetic alterations have been found in the risk of endometriosis associated with cancer; The symptomatology, imaging and endoscopic characteristics simulate other inflammatory and malignant lesions that make the preoperative diagnosis of extragonadal endometriosis difficult. This is a review of the knowledge about endometriosis and its potential risk of malignancy, particularly with colorectal cancer.
Endometriosis is a proliferative disease that is defined as the presence of endometrial glands and stroma outside the uterine cavity; or in extrauterine sites, it is a common chronic gynecological disease; the incidence in women of reproductive age is 5 to 17%; its cause is unknown; But, the accepted hypothesis is the implantation of endometrial tissue in the peritoneal cavity due to retrograde menstruation, or when endometrial tissues and cells adhere to the surfaces of the peritoneum, annexes and other pelvic organs [1-4]. The main symptoms are dysmenorrhea, pelvic pain and infertility. Although endometriosis is considered a benign condition, it shares some characteristics of cancer proliferation, such as invasion, tissue damage, neoangiogenesis and spread to distant organs [3].
The development of cancer is a rare complication of endometriosis, and mainly in some gynecological cancers 5 and others extragonadal [3], the first case of malignant transformation was described in 1925 1 of endometriosis in the intestinal tract, 17 cases have been reported of neoplastic changes 6; the most common location being the colon and rectum-sigmoid (50 to 90%) 1 small intestine (7%), blind (3.6%) and appendix (3%); other locations are in the pleura, pericardium, navel, rectovaginal septum (13%) 7, bladder, lungs, central nervous system and even skin 1, as in scars from surgeries or previous episiotomies, [5-8], (Figure 1). Despite epidemiological evidence, the association between endometriosis and cancer has not been elucidated so far.

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Friday, 12 June 2020

Iris Publishers_World Journal of Gynecology & Womens Health (WJGWH)

Efficacy in Suppressing Ovulation and Safety of a Low dose Oral Contraceptive in a Continuous Regimen (84+7) With Continuous Ethinyl Estradiol Instead of a Hormone-Free Interval: An Evaluation of Ovulation Suppression and Ovarian Activity


Abstract

Background: This study aimed to evaluate the efficacy of a low dose oral contraceptive in a continuous regimen (84+7) with continuous ethinyl estradiol (EE) instead of a hormone-free interval (HFI) (84 tablets containing 100 mcg levonorgestrel (LNG) + 20 mcg EE, and 7 tablets containing 10 mcg EE; MODELLE® LIBERA, Teva) in suppression of ovulation and ovarian activity.
Methods: A multicenter, open-label, single-treatment, Phase 3 study that evaluated 52 healthy non-pregnant females aged 18 through 35 years, of whom 47 (90%) participants completed the entire 91-day treatment. Evaluation of the efficacy of the formulation in suppressing ovulation was achieved by performing transvaginal ultrasound examinations and determining the serum concentrations of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, and progesterone.
Results: Overall, 88% of the participants presented with a lack of ovarian activity during all three 28-day intervals corresponding to a standard cycle. Ovarian suppression was reported in 99% of all cycles. The serum levels of sex hormones corresponded to the predicted values with allowance for the relevant extended mode of administration of the combined oral contraceptives (COCs). During the post-therapeutic follow-up visit, the restoration of ovulation on the post-therapeutic follow-up visit (the 20th week of the study) was reported in 45 females (87%, 95% binomial CI: 74.2%, 94.4%), 13% did not return to ovulation.
Conclusions: The efficacy of the study drug in suppressing ovulation was confirmed by the absence of ovarian activity reported in the majority of the participants over the 91-day course of treatment. Ovarian activity was detected in 2 participants (grade 4 according to the Hoogland and Skouby scale, luteinized unruptured follicle), and in each, the relevant activity was observed during the 3rd interval within the 91-day cycle during the 7-day period when only low doses of EE were administered. The underlying basis of the ovarian activity observed during the 7-day EE-only period has not been fully elucidated. The results of the study demonstrate that a low dose oral contraceptive in a continuous regimen (84+7) with continuous EE instead of a hormone-free interval is safe and can be an additional contraceptive option for healthy women seeking decreased menstrual bleeding.
Trial registration: Grls.rosminzdrav.ru (RCT №37 (28.01.2014).
Keywords: Continuous regimen; Oral contraception; Low dose; Hormone-free interval; Modelle ® Libera; LoSeasonique

Introduction

Combined oral contraceptives are effective and one of the most popular methods of contraception. Since their appearance, these medications composition and regimen have undergone changes. The traditional regimens simulate a 28-day menstrual cycle. However 91-day prolonged regimens without hormonal free intervals have already been developed. This prolonged regimen allows to decrease the frequency of menstrual-like scheduled bleeding episodes and can meet women’s social and cultural reasons.
In this study, the efficacy in suppressing ovulation and safety of low dose oral contraceptive in a continuous regimen without hormonal free intervals were evaluated. The efficacy was evaluated with the help of ultrasound examinations of the ovaries and the serum concentrations of sex hormones measurements: follicle-stimulating hormone, luteinizing hormone, estradiol, and progesterone.
52 healthy non-pregnant women have participated in the study. Suppression of ovarian function and, consequently, the effectiveness of contraceptives was observed in 99% of all cycles. No pregnancies were detected during the treatment period. The safety profile was also within the expected values. Ovarian function restoration was recorded in 87% of participants on the 20th week of the study during the follow-up period.
In conclusion, these results have demonstrated that the low dose combined oral contraceptives in a continuous regimen are effective and safe for healthy women.

Introduction

COCs are the most used reversible method of birth control and have remained the most popular form of contraception for decades, despite the introduction of other methods of contraception such as parenteral methods [1]. Approximately 9% of women globally aged 15 to 49 years prefer COCs over other methods of contraception, and this figure reaches 18% in developed countries [2], while the frequency of use of modern contraceptive methods in developed countries is generally higher. Over the years, the composition of COCs has undergone significant changes: the dose of the estrogen component has been significantly reduced, and new progestogens have been developed and included. The current practice includes administration of multiphase drugs and extended administration regimens with shorter hormone-free intervals (24/4) [1,3-6] in order to increase the efficacy, safety, and acceptability of COCs [7- 11].
Since their initial development over 50 years ago, COCs have been most administered in accordance with the standard regimen that simulates a natural 28-day cycle (21 active pills + 7-day break) [3]. This regimen was developed to mimic natural menstrual cycles. It was not designed out of medical necessity but due to cultural and social practices [12]. COCs represented a revolutionary method of controlling fertility at the time of their creation, which was supposed to be convenient for both women and physicians. The absence of the scheduled bleeding episodes raised doubts regarding the efficacy of the method and could lead to refusals to use this method of birth control, as amenorrhea was clearly associated with the onset of pregnancy some years ago [4]. Today, as there is no longer any doubt regarding the efficacy of COCs, the diagnosis of early pregnancy is relatively easy, and the use of prolonged regimens is a routine practice, the question of the expediency of the administration of COCs in the traditional cyclic regimens remains debatable.
The administration of COCs over prolonged periods of time accompanied by a predictable decrease in the frequency of menstrual-like scheduled bleeding episodes may be desirable for many women. Women express a desire to reduce the frequency of menstruation, including for social and cultural reasons [5,6,13]. Reductions in the number of menses per year contribute to improvements in the quality of life by reducing the frequency of menstrual and premenstrual symptoms. The use of prolonged administration regimens leads to a reduction in the incidence of side effects and generally increases the efficacy of contraception [3].
The development of the drugs characterized by continuous administration regimens gained popularity in the early 2000s, while studies on the use of COCs over prolonged periods of time began as far back as the 1970s. In 2003, the FDA approved a new administration regimen for COCs (84/7) [14].
The administration of extended-cycle COCs does not lead to complete suppression of ovarian function. At the beginning of the 7-day hormone-free interval, the activity of the ovaries is minimal [15]. However, due to the lack of active components during the HFI, the activity of the hypothalamic-pituitary-ovarian system axis is slowly restored as the estrogens and progestogens are metabolized. The reduction or modification of the HFI may contribute to an additional decrease in the functional activity of the ovaries [3].
In 2003, the first drug that replaced the HFI with the administration of tablets containing ultra-low doses of EE of 10 mcg/day was created [3]. The stabilizing period associated with the administration of tablets containing 10 mcg EE instead of placebo suppresses the levels of endogenous estradiol, FSH, and Inhibin-B and leads to increased suppression of ovarian follicular development, reduction in follicular growth and reduction in the risk of ovulation and, accordingly, the risk of unplanned pregnancy [16].
The study drug (MODELLE® LIBERA, Teva LLC Russia; also registered in the USA as LoSeasonique, Teva) is a low dose combined estrogen-progestogen oral contraceptive in a 91-day continuous regimen (84+7) with continuous 10 mcg EE instead of an HFI. The drug suppresses the secretion of gonadotropic hormones. The contraceptive effect is achieved in several ways, the most important of which is through the suppression of ovulation. A single package contains 84 tablets containing 100 mcg LNG and 20 mcg EE each and 7 tablets containing 10 mcg EE each. Administration of this COC reduces the number of menstrual-like bleeding episodes to just four per year. Over the last 7 days of the prolonged use of the drug (on days 85-91), the administration of 10 mcg of EE instead of placebo is associated with an increase in the suppression of the ovarian follicular apparatus and a decrease in the risk of ovulation. Menstrual-like bleeding after discontinuation of the active tablets of the drug is attributed to the absence of the progestin-mediated effect exerted on the endometrium. Meanwhile, residual suppression of the hypothalamic-pituitary-ovarian system and functional activity of the ovaries is retained during this period due to the administration of a small dose of EE [17].
The purpose of this study was to evaluate the efficacy of a low dose oral contraceptive in a continuous regimen (84+7) with continuous EE instead of an HFI in suppressing ovulation and ovarian activity. For this purpose, the following indicators were evaluated:
• Ripening of follicles in the ovaries using transvaginal ultrasound (transvaginal sonography, TVS);
• Determination of serum concentrations of FSH, LH, estradiol, and progesterone.
Additionally, restoration of ovulation function, the frequency and severity of adverse events and the frequency of pregnancies were evaluated.

Materials and Methods

Design of the study and population
The efficacy in suppression of ovulation and safety of a low dose oral contraceptive in a continuous regimen (84+7) was evaluated in an open-label multicenter (6 trial sites) study with a single group of female volunteers on the basis of the assessment of the ovarian function and the level of sex hormones (Study DR-101-WH-30007). It was planned to include 60 women in the study with a minimum of 30 women completing the 91-day treatment period. The size of the sample was calculated for the main variable of the study which was the efficacy in suppressing ovulation assessed by the ovarian activity (Hoogland & Skouby scale). It was assumed that the trial power would be 80% (β = 0.2, zβ = 0.84), the significance level α = 0.05 (zα = 1.64). It was also assumed that the efficacy of the treatment in suppressing ovulation would be established after the drug administration in 75% of volunteers (p = 0.75). The reference value of this indicator was considered equal to 50% (p0 = 0.5). It was also assumed that a difference more than 10% (d = 0.1) would indicate clinical importance. Thus, for the final analysis at least 51 female volunteers were required. Considering the possible exclusion of the participants during the treatment period up to 20%, it was necessary to screen at least 60 women for enrollment. One cohort of the participants was analyzed. The baseline characteristics, the frequency of efficacy in suppressing ovulation and safety were assessed and summarized. The significance levels and confidence intervals were calculated as two-sided; the statistical significance of the differences was also two-sided and related to the significance level of 0.05.
66 healthy females were screened for enrollment into the study. Of these women, 52 sexually active healthy females aged 18 to 35 (with the median age of 26.5 years) who agreed to use COCs as their main method of contraception throughout the entire study period of 91 days and use a double barrier method of contraception (e.g., a condom and spermicide or a diaphragm and spermicide) to prevent pregnancy were included. Of the 14 females who were not enrolled, 8 were not enrolled due to low baseline progesterone levels (<15.9 mmol/L), 2 were excluded on the basis of inclusion criteria, 2 were excluded on the basis of exclusion criteria, 1 revoked patient informed consent and 1 was lost to follow-up. Regular spontaneous menstruation occurring approximately once a month or every 23- 33 days before the screening visit, determining that the subject was ovulating, was among the inclusion criteria. The patients with contraindications to COCs and/or a history of significant adverse events associated with the administration of oral contraceptives were excluded from the study. The exclusion criteria also included the use of injectable hormonal contraceptives over a period of 6 months prior to the screening visit or the presence of a contraceptive implant/hormonal intrauterine device at the time of the screening visit. All participants were instructed during visit 1a to the study site on the regimen of taking1 tablet once a day at the same time (84 tablets of 100 mcg LNG + 20 mcg EE and 7 tablets of 10 mcg EE) during the 91 days of the treatment period.
The study included 4 stages, during which the patients were obliged to visit their study sites a total of 9 times (visits 1a-9a), corresponding to the relevant weeks of the study (Table 1).
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Wednesday, 10 June 2020

Iris Publishers_World Journal of Gynecology & Womens Health (WJGWH)

Maternal Diabetes Mellitus and Risk of Stillbirth: A Nested Case-Control Study in a Nigerian Tertiary Hospital

Abstract

Background: Stillbirths have always been a contributor to psychological morbidity amongst women. Diabetes mellitus remains a significant risk factor for its occurrence. Knowledge of the causes and risk factors of this unfortunate problem will help in designing preventive measures to reduce its incidence.
Objective: To determine the relationship between maternal diabetes mellitus and the risk of stillbirths.
Methods: This is a nested case control study conducted in the Obstetrics unit of the Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria from 1st September 2014 to 31st August 2017. Forty-four women who had stillbirth were regarded as the cases and 44 women who had livebirths were regarded as the control group were retrieved from their case files. Information obtained included; type and sex of the stillborn, maternal age, type of stillbirth, parity, educational status, booking status, gestational age, and mode of delivery. Odds ratio (OR) with 95% confidence interval was calculated to determine the relationship between maternal diabetes and the risk of stillbirth.
Results: The risk of stillbirth in diabetic pregnancies irrespective of the type was found to be two times higher than in non-diabetic pregnancies (OR 2.16, 95% CI 0.72-6.30). The mean age of the women was found to be approximately 30 years in both cases and controls. The ratio of macerated stillbirth to fresh stillbirth was 1.4:1 and females were affected more than males in a ratio of 1.3:1. The mean gestational age at delivery was 35 weeks for the cases and 38 weeks for the control group. Majority of the women included in the cases had only a primary level of education (34.1%) and never accessed antenatal care services (79.5%) as against the majority of the women in the control group who had a tertiary level of education (45.5%) and were booked for antenatal care (72.7%).
Conclusion: This study established that there is a significant association between maternal diabetes mellitus and stillbirth. The increased occurrence in the cases could be due to ignorance, lack of antenatal care, low socioenomic class and poor control of glycemic levels found among the women. Hence, the need for effective preventive/control programmes for these group of women.
Keywords:Stillbirths, Diabetes mellitus, Pregnancy

Introduction

The World Health Organization (WHO) defined stillbirth as the death of a fetus with a birth weight of at least 500g or if birth weight is unavailable [1,2], a gestational age beyond the age of viability. The stillbirth rate, as the perinatal mortality rate, is an important indicator of the quality of antenatal care and obstetric care during labor and delivery [3]. Knowledge of the causes and risk factors of this unfortunate problem will help in designing preventive measures to reduce its incidence [4]. Stillbirths are common and devastating, and in developed countries, about one-third has been shown to be of unknown or unexplained origin [5]. Some factors have been identified of which few of them have a direct causal relationship such as abruptio placentae, cord accidents, etc., while others may be indirectly related such as preeclampsia, maternal diabetes, maternal smoking, obstructed labor, maternal infections during pregnancy, etc. (all of which are modifiable factors). Stillbirth is classified as fresh stillbirth when the baby is born with an intact skin suggesting that the death occurs during labor (less than 12 hours before delivery), and macerated stillbirth, when there are signs of degeneration (pealing of skin, red serous effusions in the chest and abdomen due to Haemoglobin staining) suggesting that the death occurred more than 12-24 hours before labor [5]. Macerated stillbirths are often associated with insults that occur in utero during the antenatal period.
Diabetes concurrent with pregnancy is a high-risk condition and is associated with an increased risk of perinatal mortality [6-8] especially if poorly controlled. Other complications in the newborn include hypoglycemia, macrosomia, polycythemia, hyperbilirubinemia, respiratory distress syndrome, prematurity, shoulder dystocia, congenital anomalies, etc. [9-12].
Historically, diabetic pregnancies often ended in unexplained stillbirths [7]. Several researches and attempts have been made to identify the exact cause but has not yielded much results [9-12].
Globally, about 4% of all stillbirths remain attributable to diabetes and diabetic pregnancies continue to increase the risk for perinatal mortality [13]. Before the discovery of insulin, a woman with type 1 diabetes had almost no chance of successful delivery of a healthy baby [9]. With the advent of insulin treatment, pregnancy losses continued to be high, predominantly through stillbirths [9]. According to the WHO update, there were 2.6 million stillbirths in 2015 [10,11] accounting for over 7,178 deaths per day [11]. It has been noted that 98% of these deaths occur in the low- and middleincome populations [10]. About 66% of the worldwide stillbirths is contributed by the developing nations like India, Pakistan, Nigeria, China, Democratic Republic of Congo, Ethiopia, Bangladesh, Indonesia, Tanzania, and Afghanistan[1,2].
In this study, the authors hypothesized that there was no relationship between maternal diabetes and stillbirths (if odds ratio is <1). However, there has been extensive research into the effects of diabetes mellitus on pregnancy outcomes, and in particular on the risk of stillbirths [12,14-27] though not much work has been done in Africa and relatively none in Nigeria. This study was aimed at determining the relationship between maternal diabetes mellitus and the risk of stillbirths.

Methods

This research was carried out at the Nnamdi Azikiwe University Teaching Hospital (NAUTH) Nnewi. A nested case-control design was used to determine the relationship between maternal diabetes and the risk of stillbirth. The study population included the cases (all pregnant women who were admitted and delivered stillbirths whether fresh or macerated) and controls (pregnant women who delivered live babies during the same period in the same hospital) of stillbirths that occurred from 1st September, 2014 to 31st August, 2017. Case files of women who carried their pregnancy beyond the age of viability (28 weeks) and delivered were included while case files of women who could not carry their pregnancy up to the age of viability were excluded. The data was gotten from the medical records department. Controls were randomly chosen in a ratio of 1:1 to the cases. Data extracted included the sex of the stillborn, maternal age, type of stillbirth, parity, educational status, booking status, gestational age (GA), glycemic levels. Maternal age and comorbidities were controlled to remove potential confounders. Data was analyzed and the odds ratio (OR) and 95% Confidence interval (95%CI) calculated to check for the statistical significance. This study was approved by the Ethics committee, NAUTH and permission obtained from the Head of Department, Medical Records, NAUTH, Nnewi before the patients’ case files were retrieved. Information obtained were treated with utmost confidentiality.

Results

A total of 88 case files were analyzed during the study. The women (cases and controls) had their ages ranging from 21-42 years, with a mean age of 30.1years and 20-38 age groups with a mean age of 29.6 years respectively. Up to 56.8% of the cases of stillbirths were females, while 43.2% were males giving a ratio of 1.3:1.
A total of 88 case files were analyzed during the study. The women (cases and controls) had their ages ranging from 21-42 years, with a mean age of 30.1years and 20-38 age groups with a mean age of 29.6 years respectively. Up to 56.8% of the cases of stillbirths were females, while 43.2% were males giving a ratio of 1.3:1.
The parity of the women included in the controls were analyzed, with 52.3% being multiparous, 43.2% primiparous and 4.5% grand multiparous. Up to 36.4% of the women had a secondary level of education, 45.5% tertiary level while 18.1% stopped at primary level. A majority of the women were booked (72.7%). Considering the mode of delivery, 61.4% of the women had vaginal delivery while the remainder delivered via caesarean section (38.6%). The mean gestational age at delivery for the controls was 38.0 weeks.
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Tuesday, 9 June 2020

Iris Publishers_World Journal of Gynecology & Womens Health (WJGWH)

The Effect of Primary Surgical Technique for Treatment of Endometrial Cancer and Timing of Adjuvant Radiation Therapy

Abstract

Objective: To determine if surgical approach (open, laparoscopic, robotic) influences time to initiation of adjuvant radiation therapy in women with endometrial cancer.
Methods: The National Cancer Database was used to search for patients with stage I to III endometrial cancer who received adjuvant radiation therapy from 2010-2012. Demographic, socioeconomic and clinical information was abstracted for each patient. Time to initiation of adjuvant radiation therapy was compared between groups using univariable (unadjusted) and multivariable (adjusted for all demographic and clinical variables) Cox regression models.
Results: A total of 15,480 patients were included in our study. 47.9% of patients underwent laparotomy or an unspecified surgical approach, 38.6% underwent robotic surgery, and 13.5% had a laparoscopic surgery. The distribution of time to radiation was significantly different among these groups with hazards ratios 1.0 (reference), 1.1 [95% CI 1.07, 1.15] and 1.15 [95% CI 1.02-1.06] for open, robotic and laparoscopic surgery (p<0.0001), respectively. After adjusting for covariates, younger age and worse disease status as measured by stage and grade are associated with longer wait times to radiation.
Conclusions: Women who underwent open staging surgery for endometrial cancer experienced delays from surgery to initiation of adjuvant radiation therapy as compared to women who had minimally invasive surgery.

Introduction

Endometrial cancer (EC) is the most common gynecologic malignancy in the United States, accounting for an estimated 63,230 new cases and 11,530 deaths in 2018 [1]. Women with endometrial cancer undergo surgical staging followed by adjuvant treatment as appropriate. Adjuvant radiotherapy (RT) is commonly used for patients with early-stage high-intermediate risk disease or those with advanced disease in order to prevent locoregional recurrence. The locoregional recurrence rate for early stage endometrial cancer with risk factors is up to 26% [2,3]. For patients with advanced stage disease, despite receiving systemic chemotherapy, up to 18% of patients will develop a locoregional recurrence [4].
When feasible, minimally invasive surgery is the preferred surgical modality for EC staging and treatment [5]. Laparoscopic surgical management for EC has been shown to be a safe alternative to laparotomy. Laparoscopy as compared to open techniques results in fewer short-term complications and decreased hospital length of stay [6] with similar oncological outcomes [5,7]. A meta-analysis of the literature comparing robotic-assisted laparoscopic surgery to laparotomy for EC also revealed decreased intraoperative and postoperative complication rates, decreased postoperative morbidity, improved patient-reported outcomes, including significantly shorter return to daily activities, and equivalent survival rates [8,9]. Robotic-assisted surgery for EC has also been compared with traditional laparoscopic approach and has shown equivalent short-term outcomes [10]. The use of laparoscopy and robotic-assisted surgery for EC is increasing.
Mode of surgery influences patient recovery times and therefore may influence time from surgery to adjuvant therapy. There is evidence that time intervals between diagnosis, surgery, and initiating adjuvant treatment for patients with endometrial cancer influences outcomes [11-13]. Studies have shown that a delay between hysterectomy and adjuvant RT might portend worse outcomes. Currently, literature exploring this relationship is limited. One retrospective study showed that initiating adjuvant RT more than six weeks after surgery decreased disease-specific survival for EC [11]. Others have found that local recurrence rate was associated with time interval from surgery to RT using a cutoff of nine weeks [12,13]. Given the advent of minimally invasive surgery, we sought to evaluate the impact of surgical technique on the time interval for initiating adjuvant radiation therapy for patients with endometrial cancer.

Methods

The National Cancer Database (NCDB) is a national hospitalbased cancer registry that is a joint endeavor of the American College of Surgeons and American Cancer Society. Annually, data from over 1 million patients representing 70% of all new cancer diagnoses in the United States are reported to the NCDB. Approximately 1,500 Commission on Cancer (CoC)-accredited hospitals contribute deidentified data. Data reporting is highly standardized to the CoC Registry Manuals, the American Joint Committee on Cancer and Collaborative Stage manuals, and the International Classification of Diseases for Oncology, Third Edition (ICD-O-1) [14,15]. The Institutional Review Board at the Icahn School of Mount Sinai granted exemption status for this study.
The NCDB Participant User File was used to search for patients with stage I to III EC who underwent primary surgical treatment and for whom the surgical technique was known from 2010 to 2012. Only those patients with a known cancer diagnosis prior to surgery who also received adjuvant radiotherapy were included in the study. The types of adjuvant RT delivered were external beam radiation therapy (EBRT), brachytherapy, radioisotopes, or combined EBRT with brachytherapy boost or radioisotopes. Patients who received radiation outside of the uterus, cervix, pelvis or abdomen were excluded. Demographic and socioeconomic information was abstracted for each patient, including age, year of diagnosis, race/ ethnicity, income, insurance status, and facility location. Clinical data collected included Charlson-Deyo comorbidity score, surgical approach, time to radiation, and time hospitalized. Pathologic details recorded included International Federation of Gynecology and Obstetrics (FIGO) staging and grade of disease.
Patients were categorized into three groups according to surgical approach: robotic, laparoscopic, and open or unspecified. Patients whose surgical approach was not reported were categorized as unspecified and grouped with patients who underwent open surgery by the NCDB. Demographic and clinical characteristics were compared between the groups using one-way ANOVA or Kruskal-Wallis tests for continuous measures and Chi-square tests for categorical measures. The distribution of time to adjuvant radiation by surgical approach was estimated using the Kaplan Meier method and differences between the groups were assessed using a log-rank test. Univariable (unadjusted) and multivariable (adjusted for all demographic and clinical variables) Cox regression models were estimated to assess each factor’s association with time to adjuvant radiation therapy. All analyses were conducted using SAS version 9.4 (SAS, Cary, NC).

Results

A total of 15,480 patients diagnosed with endometrial cancer from 2010 to 2012 met inclusion criteria. Of these, 47.9% had a laparotomy or unspecified surgical approach, 38.6% underwent robotic surgery, and 13.5% had a laparoscopic surgery. Although statistically significant due to the large sample size, there were no clinically significant differences between the groups based on age, income, insurance status, facility location, and Charlson-Deyo score (Table 1). The robotic group had a higher proportion of white patients compared to both the laparoscopic and open/unspecified groups. The open/unspecified group had proportionately more stage 3 and grade 3 and 4 (undifferentiated or anaplastic) patients compared to the robotic and laparoscopic groups. As expected, the length of stay in hospital was also significantly longer for open/ unspecified patients compared to patients who underwent less invasive procedures. Notably, the distribution of year of diagnosis varied by surgical group with the percentage of patients in both the robotic and laparoscopic increasing by year versus decreasing in the open/unspecified group.
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Monday, 8 June 2020

Iris Publishers_World Journal of Gynecology & Womens Health (WJGWH)

Training of Health Promotion Agents: An Intervention in the Baoulé Community of Kongodékro (North- Central Côte d’Ivoire)

Abstract

The training of health promotion agents meets a healthy expectation in front of the multiplicity and complexity of health problems in Côte d’Ivoire. In order to establish the mechanism of behavioral change in the population, a simulation put the auditors in a situation of intervention in the village of Kongodékro. This process helped to identify priority problems and solutions, to plan activities and to define follow-up procedures, evaluate and archive reports. This scenario is a unique experience to strengthen and enhance the skills and values of community health auditors.
Keywords: Transformative action; Community approach; Capacity strengthen; Health

Introduction

Public health problems in Côte d’Ivoire are dominated by infectious and parasitic diseases, the most important of which are malaria, diarrheal diseases and pneumonia. Children and pregnant women are the most vulnerable and affected populations [1]. To this alarming situation is added the progression of chronic and degenerative diseases. From this complex health situation comes a life expectancy backwards. How can the vast majority of the population benefit from a viable health at a lower cost and reduce the burden of disease in Côte d’Ivoire? The relevant assumption for a sustainable health for the entire population is the establishment of a health promotion system anchored in lifestyle. It is an immersion framework in which the different social strata of the population take charge of their own health by acting on the risk factors [2]. This dynamic health framework requires coordinated action [3]. In this context, nurses, midwives and doctors are recruited from the community health training program at Alassane Ouattara University in Bouaké. They are trained in a two-year cycle with the skills of health promotion agents. It is for these auditors to strengthen their ability to support the community in order to define the priorities of health problems, solutions, action plans to change behavior. To be convinced, a simulation aimed at putting auditors in a field intervention situation took place in the village of Kongodékro. In reality, it is about implementing the development and implementation of a community health project. This intervention is understood as an emulation based on the values, knowledge and know-how of stakeholders beneficial to the health of populations. This dynamic training process is based on a particular approach.

Implementation

The immersion of auditors in the community recommended a scenario. The stages of the scenario are the preparatory phase of the field, the community diagnosis, the community feedback workshop and the presentation of the implementation reports. The purpose of these activities is to master the participatory and community approach to strengthen the skills of health promotion agents.

The Preparatory Phase of the Field

This phase took place a week before the release. It revolves around the prospecting mission, the development of the administrative protocol and the development of tools for community diagnosis.
The prospecting missions
The prospecting mission was entrusted to a group of auditors. The village of Kongodékro in north-central Côte d’Ivoire has been identified as the investigative community. Physical contact with the various local, political, administrative and customary authorities has led to good community mobilization, a guarantee of success for the community health project. Subsequently, this community visit also led to the identification of all the health problems with the community and staff at the local health center. There is a high rate of consultation related to malaria, diarrheal diseases in children, acute respiratory failure, inadequate antenatal care, unaided deliveries, and unsanitary conditions. From the exchanges, the epidemiological profiles of the locality in question were identified and validated by seeking the reason of their priority character by the local community. It is therefore the low use of maternal services of Kongodékro by pregnant women and the insalubrity. From the identification and validation of the priority problems, it is necessary to move on to the administrative protocol.
The administrative protocol
This administrative approach was the work of a group of auditors. As part of the field intervention, it consisted of informing local, political, administrative or departmental, and customary authorities of the scientific intent of the research project through correspondence issued by the academic authority. This administrative procedure leads to the development of tools for community diagnosis.
Development of community diagnostic tools
The phase of identification and development of community diagnostic tools was organized with all the auditors. Two working groups were formed to address each one a priority health issue. From a research-action perspective, the following data collection techniques were retained: the review of birth registers, the focus group, the historical profile and the field visit. All these tools have been validated under the supervision of the supervisors. It is now a question of how the actual community diagnosis is conducted in the field.

Community Diagnosis

It marks the effectiveness of investigations in the field. It relies on a ritual of civility prior to the implementation of the collection scenario and data analysis.
The ritual of civility
The ritual of civility was here a moment of communion of the entire delegation with the local chieftaincy, the health workers and the community. During this protocol of use, exchanges of news, the knowledge with the notability, the clarification of the object of the mission and the course of the range of the activities furnished these moments. As a result of this sharing, a favorable opinion was issued by the chieftaincy and the community, as well as thanks by the delegation of auditors for their agreement. A libation made by the chief of the village of kongodékro thus symbolically testified to the community’s support for this community intervention. As a result of this usage protocol, the data collection scenario was put in place.
Setting up the data collection and analysis scenario
The implementation of the data collection and analysis scenario put auditors and the community in contact. Its objective was to first have a collection of information focused on the priority problems from the data collection tools developed and then a fact by bringing the various stakeholders to explain more information collected. This modality of organization of the facts led to the restitution workshop in the community.

The Restitution Workshop in the Community

The restitution workshop in the community sparked an animation between the auditors and the community. Its objective has been to identify priority issues, identify priority solutions, plan activities, assign tasks, roles and responsibilities in the implementation and definition of monitoring and evaluation modalities archiving of reports by the community. At the end of this planning, all of this implementation needs to be written into reports.

Presentation of Implementation Reports

The implementation reports include a mission report and a scientific report. They were the subject of group work, exchange, evaluation and lessons learned by auditors. The mission report concerned the description of the entire process of the intervention. It has an administrative character and has been addressed to the administrative, customary and community authorities and local health workers. The scientific report is seen as a document for implementing community health. It has a scientific character and it has been addressed to the academic authority in order to highlight the results in terms of impact in the short and medium term and to give a scientific opinion on the problems identified, the results and make recommendations.

Results

The results to be observed are marked by a scientific character. They derive from the implementation of community health through the community diagnosis and the action matrix. They are perceived at two levels of problematic situation: the low use of maternity services of Kongodékro by the pregnant women and the insalubrity in said village.

The problem of the Use of Maternity Services at the Kongodékro Health Center by Pregnant Women

Inadequate antenatal care
The analysis of the low use of maternity services has led the community to identify several sensitive risk factors and possible solutions.
The first priority problem was the lack of antenatal care. Faced with this situation, two priority solutions have been proposed by the community.
Initially, it would involve more involvement of spouses in the prenatal consultations of their wives. To do this, the social actors committed to the task would be the community health worker and the midwife. These should respectively provide door-to-door outreach in the village through megaphone and couple counseling during prenatal consultations at the health center from the picture boxes. In terms of evaluation, the number of spouses sensitized and the number of spouses accompanying their wives in prenatal consultation would make it possible to assess the process and the effectiveness of this action.
In a second step, it would be a question of sensitizing the pregnant women to respect the appointments of the prenatal consultations. The midwife, community health worker and spouses would be available, respectively, to provide counseling, doorto- door outreach, and the search for the lost to the image box, megaphone, and follow-up prenatal consultation records seen in this activity. In the medium and long term, the number of pregnant women sensitized on the respect of prenatal consultations and the antenatal consultation rate greater than or equal to four would be indicators of the monitoring and effectiveness of this action.
Low rate of assisted deliveries
The second priority problem was the low birth rate in the Kongogodekro maternity ward. In this case, the community has suggested four priority solutions.
First, there was the reorganization of the maternity service, including permanency and care. This activity would be the responsibility of the midwife through service meetings. For this, the provision of office and an equipped guard room would be among other laudable means. 24 hours a day, seven days a week at the Kongodékro Health Center, as well as one hundred percent (100%) of the hours of duty and guards each month should reflect the reality of implementation. express the achievement of this activity.
Secondly, the good collaboration between the health staff, particularly the midwife and the community, was emphasized. The actors willing to do this task would include the midwife and the entire community. The organization of exchange meetings with the community using material means such as the megaphone, chairs and a meeting room as well as home visits should be useful to the realization of this solution. Thus, the number of home visits made, i.e. four visits by the midwife a month, and two midwife exchanges with the community per month should express the achievement and effectiveness of this action.
Third, the construction of housing for the midwife has been accepted. This activity would be the responsibility of the people and the officials of the village. In this initiative, it would be a question of making a plea to the administrative authorities and to encourage the mobilization and the participation of the village community. To do this, letters to the mayor and the regional council and the contribution of the community would be the means available. In this process, the monitoring indicators would be the written letters sent to the town hall and the regional council and then the levy within the community is ten percent (10%) of the project budget. As for the efficiency indicator, it would be observable through the number of members of the community to have contributed at a given period and the external contributions obtained from the decentralized communities.
This community diagnosis and the planning of activities in the field of reproductive health leads to a glimpse of the problems and solutions identified in the case of environmental health.
The problem of insalubrity in the village of Kongodekro
In the analysis of the unsanitary situation, the priority problems relating to the lack of initiative of sanitary activities and the proliferation of wild garbage dumps were similarly identified, and the means to act on these problems were identified.
Lack of initiative of safety activities
Regarding the problem of lack of initiative of the health activities, two priority solutions were admitted by the community.
First, the planning of health activities was noted. It should be carried out by community leaders and health workers. They would be required to hold exchange meetings to develop safety implementation activities. To do this, notebooks, pens and computers would serve as work media. All in all, the holding of four exchange meetings and the provision of a business plan should convince the realization of this solution.
The cleaning of the living environment was then observed. This activity would be the work of the young men and women of the village from operation brooms, garbage collection, cleaning open septic tanks and installation of garbage cans. These property actions would require, as means, wheelbarrows, gloves, machetes, rakes, dabas, shovels, brooms, mufflers. Moreover, two days of sanitation every month would testify to the effectiveness of this activity.
Proliferation of wild garbage dumps
Concerning the problem of proliferation of wild garbage dumps, two priority solutions were chosen by the community.
In the first place, the use of household garbage cans would affect all households. It would be for people in each family to throw garbage in the garbage. These would identify with used buckets and plastic bins. Their presence in the majority of households should express the realization of this solution.
Secondly, the creation of dumps for the village would mobilize the whole community. The goal would be to build a site outside the village for garbage collection. If necessary, machetes, shovels, picks and wheelbarrows would be the means of action. The presence of an operational dump is an indicator of the achievement of this activity.
In the light of the real problems that arise, and the appropriate actions defined in this matrix of actions of the village of Kongodékro, what lessons can be learned from this community intervention?

Implications

The critical examination of the community intervention in Kongodékro village revealed the strengths and weaknesses of this activity.
The forces concerned legal authorization, social legitimacy, the availability of social actors (health professionals & population), the immersion of facilitators in the community and the use of appropriate tools for community diagnosis.
The weaknesses were related to the absence of some members of the community during the restitution, to the absence of investigators trained for the collection of information, to the absence of cross-cutting questions put to the interlocutors in the sense of the modalities of solutions, the omission of certain collection tools such as the seasonal calendar and the Venn diagram essential for the planning of activities.
Ultimately, it is important to remember that although the steps in the development of a community health project are defined, none of them is fixed. The methodology must be rigorously respected. The development of a community health project is essentially based on the community, i.e. its total involvement under the control of a facilitator.

Conclusion

This intervention in the community of kongodekro allowed the immersion of community health auditors. In this context, the preparatory phase of the field, the community diagnosis and the restitution workshop in the community were the steps of the process. At the end of these stages, priority problems were identified, and action plans were defined. This scenario is a unique experience to strengthen and enhance the skills and values of community health auditors. The community approach, as exciting as it is painful, requires the openness, availability and humility of health promotion agents. This appears as a guarantee of access to local knowledge and practices, behavioral changes within the population and support for the control of their own health.
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