Laparoscopic Falciform Ligament Flap Versus Omental Patch for Perforated Peptic Ulcers
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: 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.
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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.
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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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of participants with post-operative repair-site leakage
Zeitfenster: 30 days post-surgery
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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.
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30 days post-surgery
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Falciform vs Omentopexy in PPU
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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