Laparoscopic Versus Transvaginal Approaches in Repair of Uterine Niche: A Randomized Controlled Trial

Study Overview
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Brief Summary
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The treatment of uterine niche ranges from clinical management with expectant or pharmacological treatment, surgical treatment. Approaches for repair include Laparotomy, laparoscopy , hysteroscopy , vaginal. The decision to treat takes into consideration the size of the defect, presence of symptoms, secondary infertility and plans of pregnancy. All of the approaches have its merits and debates. There is ongoing debate regarding the best surgical approach to managing this condition. To date no randomized controlled trials have been published to settle this debate. Our study aim is to to evaluate which surgical approach is a preferable option, this study will be conducted to compare the Laparoscopic and transvaginal approaches in several regards, including, operation time, blood loss, perioperative complications, hospital stay length, postoperative increase in residual myometrial thickness during follow-up , clinical efficacy(percentage of patients who subject improvement of symptoms)

Official Title
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Laparoscopic Versus Transvaginal Approaches in Repair of Uterine Niche: A Randomized Controlled Trial

Conditions
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Uterine Niche

Intervention / Treatment
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* Procedure: Laparoscopic repair of Uterine niche
* Procedure: Transvaginal repair of Uterine niche


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients who have uterine niche (defined as myometrial discontinuity or a hypoechoic triangle in the myometrium of the anterior uterine wall at the site of hysterotomy presented in transvaginal ultrasound or sonohysterography examination in non-pregnant women) ,with one or more previous caesarean section Who are: Symptomatic i.e patients having one or more of the following symptoms: Postmenstrual spotting (defined as more than 2 days of brownish discharge at the end of menstruation with a total length of menstruation (including spotting) of more than 7 days, or intermenstrual bleeding which starts within 5 days after the end of menstruation. [15]), Secondary Dysmenorrhea( defined as the pain or discomfort associated with menstruation) deep dyspareunia(deep genital pain associated with sexual intercourse) Chronic pelvic pain can be defined as intermittent or constant pain in the lower abdomen or pelvis of a woman of at least 6 months in duration, not occurring exclusively with menstruation or intercourse and not associated with pregnancy. secondary infertility (defined by the World Health Organization as, -when a woman is unable to bear a child, either due to the inability to become pregnant or the inability to carry a pregnancy to a live birth following either a previous pregnancy or previous ability to carry a pregnancy to a live birth.) Asymptomatic patients with one of the followings: the residual myometrial thickness over the niche less than 3 mm previous history of Cesarean Section scar ectopic pregnancy (not managed by resection and repair) who accept to participate the study. Exclusion Criteria: Asymptomatic patients with residual myometrial thickness more than 3 mm. No previous Cesarean section. If the patients symptoms presented before Cesarean section. Presence of other pathology that explain patient symptoms sub mucous fibroid cervical-Endometrial carcinoma Endometrial hyperplasia Coagulation defect. Presence of pathology that necessitate laparotomy. Patient who refuse to participate the study.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic approach group(A)<br>Uterine niche will be repaired through Laparoscopic approach. | Procedure: Laparoscopic repair of Uterine niche<br>* Repair of uterine niche through Laparoscopic approach.<br>|
| Active Comparator: Transvaginal approach group(B)<br>Uterine niche will be repaired through Transvaginal approach. | Procedure: Transvaginal repair of Uterine niche<br>* Repair of uterine niche through Transvaginal approach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy | Number of patients who subject clinical improvement of pre-operative symptoms | 3 month postoperative | 
| Post-operative increase in residual myometrial thickness | difference between pre-operative & post-operative residual myometrial thickness | 3 month postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of operation | duration from anesthesia till end of operation | baseline( During operation) | 
| Blood loss | estimated blood loss during operation(towels , suction container) | baseline( During operation) | 
| Intra-operative complication | complication during the operation | baseline( During operation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean Scar defect