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Not yet recruitingNCT07813780Updated Sep 10, 2026

Laparoscopic Falciform Ligament Flap Versus Omental Patch for Perforated Peptic Ulcers

An interventional study of Laparoscopic Falciform Ligament Flap Repair and Laparoscopic Omental Patch Repair in Perforated Peptic Ulcer, Peptic Ulcer Perforation and Duodenal Ulcer Perforation, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Perforated Peptic Ulcer
  • Peptic Ulcer Perforation
  • Duodenal Ulcer Perforation
  • Gastric Ulcer Perforation

Keywords

  • Falciform ligament flap
  • Falciformopexy
  • Omental patch
  • Graham patch
  • Laparoscopic repair
  • Minimally invasive surgery
  • Repair-site leak
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureLaparoscopic 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.

  • ProcedureLaparoscopic 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.

05

What researchers measure

Primary outcomes

  1. Number of participants with post-operative repair-site leakage

    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.

    Time frame: 30 days post-surgery

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07813780
Lead sponsor
Assiut University
Responsible party
Habiba Abdelradii Abdelraheem Hassan (Resident, Assiut University) — Principal investigator
First posted
Sep 10, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Sep 10, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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