Laparoscopic Versus Combined Laparoscopic and Hysteroscopic Repair of CS Niche
- Conditions
- Cesarean Scar Niche
- Interventions
- Procedure: Combined hysteroscopic and laparoscopic repair of cesarean scar nicheProcedure: laparoscopic repair of cesarean scar niche
- Registration Number
- NCT05777837
- Lead Sponsor
- Zagazig University
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 30
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combined Hysteroscopic and Laparoscopic Repair without Excision of Large Cesarean Scar Niche Combined hysteroscopic and laparoscopic repair of cesarean scar niche - Laparoscopic Excision of Large Cesarean Scar Niche laparoscopic repair of cesarean scar niche -
- Primary Outcome Measures
Name Time Method change of the residual myometrium thickness will be measured at the 3-month and 6-month ultrasound measurement of the residual myometrium will be done
reduction of postmenstrual bleeding will be assessed at the 3-month and 6-month participants will report their perception of the amount of bleeding using a questionnaire
- Secondary Outcome Measures
Name Time Method Subsequent fertility outcome 1 year the incidence of subsequent conception following intervention will be recorded
Trial Locations
- Locations (1)
Faculty of Medicine
🇪🇬Zagazig City, Egypt