Vasopressin vs. Uterine Artery Clamping for Laparoscopic Cesarean Scar Niche Repair

Zagazig University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cesarean Section Complications

Interventions

Vasopressin GroupDRUG

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.

Bulldog Clamping GroupPROCEDURE

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.

Standard of CarePROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Dr. Samir Abbas Hospital

Jeddah, Saudi Arabia

Outcomes

Primary Outcomes

Mean Hemoglobin Deficit Mean Hemoglobin Deficit

The difference between preoperative and postoperative hemoglobin concentrations, used as a primary indicator of intraoperative blood loss.

Time frame: 24 hours post-surgery.

Secondary Outcomes

Surgical Field Visibility (SFV) Score

Assessment of the clarity of the surgical field using Boezaart's scale (0-5), where lower scores indicate better visibility.

Time frame: Intraoperative

Total Operative Time

Duration of the surgical procedure from the initial incision to the completion of myometrial reconstruction.

Time frame: Intraoperative

Data from ClinicalTrials.gov

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