Laparoscopic Versus Combined Laparoscopic and Hysteroscopic Repair of CS Niche

Study Overview
=================
Brief Summary
-----------------
Uterine niche is a frequent condition in patients with a history of cesarean section. Many treatment methods have been described for repair of niche with varying effectivities. In conventional Laparoscopic approach, not all bleeding points and fibrotic area are resected, while conventional hysteroscopic one result in more wide defect with high risk of recurrence and cannot be used in large niche with low RMT. In this new Double approach (hysteroscopy and laparoscopy) technique, the benefit of both laparoscopy and hysteroscopy will be attained.

Detailed Description
-----------------
In all patient involved in the study, laparoscopic entry will be done, then adhesiolysis and creation of the bladder flap(dissection of the bladder from the uterine scar) then: Group (I): Laparoscopic Excision of large cesarean scar niche: Intentional perforation of the niche will be done using uterine sound and excision of the fibrotic edges then suturing the uterine incision using 2-0 absorbable suture. Group (II): Combined hysteroscopic and laparoscopic repair without excision of large cesarean scar niche: The investigators will do the hysteroscopic resection of the niche under laparoscopic guide to avoid perforation of the niche. After completion of the hysteroscopic approach, laparoscopic plication of the niche without opening it will be done using multiple interrupted 2-0 absorbable suture After suturing, the hysteroscopy will be introduced again to assess the repair The patient will be sent home the day after. They will be followed up after 3 and 6 months. Checkup of CSD repair: After 6 month of surgery both groups will be examined using sonohysterography to assess the changes in niche diameters Core outcome sets: Enlargement of the residual myometrium thickness and reduction of postmenstrual bleeding will be measured at the 3-month and 6-month. Subsequent fertility outcome

Official Title
-----------------
Laparoscopic Excision Versus Combined Hysteroscopic and Laparoscopic Repair Without Excision of Large Cesarean Scar Niche: A Randomized Controlled Trial

Conditions
-----------------
Cesarean Scar Niche

Intervention / Treatment
-----------------
* Procedure: laparoscopic repair of cesarean scar niche
* Procedure: Combined hysteroscopic and laparoscopic repair of cesarean scar niche


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of cesarean section Postmenstrual and or intermenstrual spotting Large Cesarean scar niche, depth more than 50% of adjacent myometrial thickness (AMT). Failed medical treatment Signed informed consent. Exclusion Criteria: A contraindication for a hysteroscopic niche resection Women with a positive pregnancy test. A contraindication for general or local anaesthesia. Coagulation disorders that lead to higher risks on bleeding or anticoagulant use. A (suspected) malignancy, endometrial polyps, atypical endometrial cells, cervical dysplasia, hydrosalpinx that may communicate with the uterus. Adenomyosis or leiomyoma (the International Federation of Gynecology and Obstetrics (FIGO) leiomyomia subclassification system Type 0, 1, 2, 3) or large leiomyomas causing the uterine cavity length to be ≥ 9 cm as examined by transvaginal ultrasound or MRI. Endocrine disorders that interfere with the menstrual cycle. Irregular menstrual cycle (>35 days or intercycle variation of 2 weeks or more). Patients who are not willing to conceive before and/or after the hysteroscopic surgery.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic Excision of Large Cesarean Scar Niche<br> | Procedure: laparoscopic repair of cesarean scar niche<br>* Intentional perforation of the niche will be done using uterine sound and excision of the fibrotic edges then suturing the uterine incision using 2-0 absorbable suture.<br>* Other names: laparoscopic excision of cesarean scar niche;|
| Active Comparator: Combined Hysteroscopic and Laparoscopic Repair without Excision of Large Cesarean Scar Niche<br> | Procedure: Combined hysteroscopic and laparoscopic repair of cesarean scar niche<br>* Hysteroscopic resection of the niche under laparoscopic guide will be done to avoid perforation of the niche. After completion of the hysteroscopic approach, laparoscopic plication of the niche without opening it will be done using multiple interrupted 2-0 absorbable suture.<br>* Other names: Combined hysteroscopic and laparoscopic repair without excision of large cesarean scar niche;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of the residual myometrium thickness | ultrasound measurement of the residual myometrium will be done | will be measured at the 3-month and 6-month | 
| reduction of postmenstrual bleeding | participants will report their perception of the amount of bleeding using a questionnaire | will be assessed at the 3-month and 6-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subsequent fertility outcome | the incidence of subsequent conception following intervention will be recorded | 1 year |