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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vasopressin Group (Group V) | Active Comparator | Patients receiving intramyometrial injection of diluted vasopressin (12 mL) surrounding the niche before excision. |
|
| Uterine Artery Clamping Group (Group B) | Active Comparator | Patients undergoing bilateral temporary uterine artery occlusion (BUAO) using laparoscopic bulldog vascular clips before niche excision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vasopressin Group | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Hemoglobin Deficit Mean Hemoglobin Deficit | The difference between preoperative and postoperative hemoglobin concentrations, used as a primary indicator of intraoperative blood loss. | 24 hours post-surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraoperative |
| Total Operative Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Samir Abbas Hospital | Jeddah | 23411 | Saudi Arabia |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Bulldog Clamping Group | Procedure | 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 Care | Procedure | 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. |
|
Duration of the surgical procedure from the initial incision to the completion of myometrial reconstruction.
| Intraoperative |