Cesarean Section Complications
Conditions
Brief summary
This study evaluates two methods for controlling intraoperative bleeding during laparoscopic surgery to repair a cesarean scar niche (CSN). It compares the effectiveness of intramyometrial vasopressin injection against bilateral temporary clamping of the uterine arteries using laparoscopic bulldog clips. The goal is to determine if vasopressin injection is non-inferior to arterial clamping in reducing blood loss and maintaining surgical field visibility.
Interventions
Patients receive a local injection of 12 mL of diluted vasopressin into the myometrium directly surrounding the cesarean scar niche. This is performed during the laparoscopic procedure, just before the excision of the fibrous scar tissue, to constrict local blood vessels and minimize intraoperative bleeding.
PROCEDUREBulldog Clamping Group
This intervention involves the temporary mechanical clamping of both uterine arteries using laparoscopic bulldog vascular clips. The clips are applied to block blood flow to the uterus before the niche is excised and are removed once the myometrial reconstruction is complete.
PROCEDUREStandard of Care
Approach: A 3-port laparoscopic approach using Storz endoscopic instruments. Excision: Complete removal of the fibrous scar tissue surrounding the niche defect. Reconstruction: Suturing and repair of the myometrium to resolve the defect.
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of symptomatic CSN. * Scheduled for laparoscopic excision and repair.
Exclusion criteria
* Contraindications to vasopressin (e.g., severe hypertension or cardiovascular disease). * Presence of other major uterine pathologies (e.g., large myomas or malignancy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Hemoglobin Deficit Mean Hemoglobin Deficit | 24 hours post-surgery. | The difference between preoperative and postoperative hemoglobin concentrations, used as a primary indicator of intraoperative blood loss. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Field Visibility (SFV) Score | Intraoperative | Assessment of the clarity of the surgical field using Boezaart's scale (0-5), where lower scores indicate better visibility. |
| Total Operative Time | Intraoperative | Duration of the surgical procedure from the initial incision to the completion of myometrial reconstruction. |
Countries
Saudi Arabia
Outcome results
None listed