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NOT YET RECRUITING
NCT07813780
NA

Laparoscopic Falciform Ligament Flap Versus Omental Patch for Perforated Peptic Ulcers

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

Peptic ulcer perforation is a serious complication of peptic ulcer disease that requires urgent surgical treatment. The standard minimally invasive method is laparoscopic omental patch repair, in which a portion of the patient's greater omentum is placed over the ulcer perforation to seal the defect. However, in some patients, the omentum may be scarred, retracted, or unavailable due to prior surgery, and postoperative leakage can still occur. The falciform ligament, which is a well-vascularized tissue fold connecting the liver to the anterior abdominal wall, serves as an alternative tissue flap for ulcer closure. The purpose of this prospective randomized clinical trial is to compare the safety and efficacy of laparoscopic falciform ligament flap repair against conventional laparoscopic omental patch repair in adult patients with perforated gastric or duodenal peptic ulcers measuring 2 cm or less. Participants eligible for laparoscopic repair are randomly assigned during surgery to one of two groups: * Group A (Active Comparator): Undergoes laparoscopic omental patch repair (Graham technique). * Group B (Experimental): Undergoes laparoscopic pedicled falciform ligament flap repair. The primary objective is to determine whether the falciform ligament flap reduces or demonstrates comparable rates of postoperative repair-site leakage within 30 days after surgery. Secondary objectives include comparing operative duration, intra-operative blood loss, rates of conversion to open surgery, post-operative pain scores, length of hospital stay, 30-day morbidity and mortality, and endoscopic ulcer healing at 6 to 8 weeks of follow-up.

Official title: Laparoscopic Falciform Ligament Flap Versus Omental Patch Repair for the Treatment of Perforated Peptic Ulcers: A Prospective Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-10

Completion Date

2027-11

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

PROCEDURE

Laparoscopic Falciform Ligament Flap Repair

The falciform ligament is mobilized by dividing its peritoneal attachment to the anterior abdominal wall cephalad toward the liver until a tension-free pedicle of adequate length and mobility is achieved. The pedicle is delivered over the perforation and secured using pre-placed interrupted full-thickness sero-muscular absorbable sutures.

PROCEDURE

Laparoscopic Omental Patch Repair

A well-vascularized omental tongue is mobilized on its pedicle, laid over the perforation defect, and secured by tying 2 to 3 pre-placed interrupted full-thickness sero-muscular sutures over it. It is then reinforced with 2 to 3 additional interrupted sutures anchoring the omentum to the ulcer edge.