Laparoscopic Falciform Ligament Flap Versus Omental Patch for Perforated Peptic Ulcers

September 6, 2026 updated by: Habiba Abdelradii Abdelraheem Hassan, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients aged 18 years or older, of either biological sex.
  • Intra-operative diagnosis of a perforated gastric or duodenal peptic ulcer.
  • Perforation size ≤ 2 cm, judged suitable for closure with a patch technique rather than resection.
  • Hemodynamically stable enough to tolerate pneumoperitoneum and general anesthesia (American Society of Anesthesiologists [ASA] class I-III).
  • Presentation within 24 hours of onset of symptoms, or beyond 24 hours provided the patient remains a safe candidate for laparoscopy.
  • Patient (or legal guardian, where applicable) willing and able to provide written informed consent.

Exclusion Criteria:

  • Perforation size > 2 cm, or intra-operative findings requiring gastrectomy, duodenal exclusion, or other resectional surgery.
  • Suspicion or histopathological confirmation of a malignant gastric ulcer.
  • Generalized fecal or severe purulent peritonitis with septic shock or hemodynamic instability precluding a laparoscopic approach.
  • Severe cardiopulmonary disease or other contraindication to general anesthesia or pneumoperitoneum (ASA class IV-V).
  • Previous upper abdominal or hepatobiliary surgery that has excised or rendered the falciform ligament unavailable, or that precludes safe laparoscopic access.
  • Pregnancy.
  • Uncorrected coagulopathy.
  • Refusal of consent, or inability to comply with the planned post-operative follow-up schedule.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: Laparoscopic Omental Patch Repair
Participants undergo laparoscopic repair of perforated peptic ulcer using a conventional omental (Graham) patch. A well-vascularized omental tongue is mobilized on its pedicle, laid over the perforation defect, secured by tying pre-placed full-thickness sero-muscular sutures over it, and reinforced with 2 to 3 additional interrupted sutures anchoring the omentum to the ulcer edge.
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.
Experimental: Group B: Laparoscopic Falciform Ligament Flap Repair
Participants undergo laparoscopic repair of perforated peptic ulcer using a pedicled falciform ligament flap. 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, which is then delivered over the defect and secured with pre-placed sutures.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with post-operative repair-site leakage
Time Frame: 30 days post-surgery
Post-operative repair-site leakage is defined as clinical leakage (e.g., persistent bilious or enteric discharge from intra-abdominal drains, worsening signs of peritonitis) and/or radiologically confirmed leakage using an oral water-soluble contrast examination or contrast-enhanced abdominal computed tomography (CT) scan.
30 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

September 6, 2026

First Submitted That Met QC Criteria

September 6, 2026

First Posted (Actual)

September 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 6, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Falciform vs Omentopexy in PPU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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