Falciformopexy for Treatment Perforated Peptic Ulcer.

Falciformopexy for Treatment Perforated Peptic

Use the falciform ligament flap for the treatment of perforated peptic ulcer

Study Overview

• Status: Not yet recruiting
• Conditions: Perforated Peptic Ulcer
• Intervention / Treatment: Procedure: Falciformopexy for Treatment Perforated Peptic Ulcer

Detailed Description

Peptic ulcer perforation (PUP) is one in all the foremost common critical surgical emergencies. The omentum flap is usually wont to cover a PUP. However, the omentum can not be utilized in cases of severe peritonitis or previous surgical removal. this is often the primary study conducted in Vietnam that was designed to analyse the outcomes of patients with PUPs who were treated using the ligament.

In the population, the prevalence of ulcer disease supported physician diagnosis ranges from 0.12% to 1.50%, and hospitalization rates range from 0.10% to 0.19%. ulceration perforation (PUP) is one of the foremost common surgical emergencies worldwide, which is necessitate emergent surgical intervention.

the death rate of PUPs is between 1.3% and 20%, and mortality thanks to a perforation of a gastric ulcer is over mortality because of a perforation of a duodenal ulcer (40% vs 10%) . Some studies have shown that having comorbidities, being over 70 years old, undergoing surgical procedure after 36 h, PUP diameter greater than 1 cm2 and postoperative com- plications are associated with mortality. The technique of using the omental patch for repair PUP is commonest now thanks to mobility and vascularity but is also using the falciform ligament in some cases due to highly vascularity.

The technique of using the falciform ligament for the treatment of PUPs was reported in 1978 by Fry . The purpose of the study was to explain the technique and therefore the results of using the falciform ligament for the treat- ment of PUPs during a large volume surgical centre in Assuit university hospital found the falciform patch to be a successful technique in repair PUP and is assumed to be as effective as omental patch but more advantage because of highly vascular.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Any cases presented with PPU within age from 18 till 70 years.

Exclusion Criteria:

• malignancy.
• Previous GIT and liver surgery.
• nonoperative treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Falciformopexy for Treatment Perforated Peptic Ulcer; Use falciform ligament flap for repair perforated peptic ulcer	Procedure: Falciformopexy for Treatment Perforated Peptic Ulcer; use the falciform ligament on perforated peptic ulcer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Falciformopexy for Treatment Perforated Peptic Ulcer	The aim is to decrease incidence of leakage from the perforated peptic ulcer by using the falciform ligament for repair of the perforated peptic ulcer. Firstly, the investigator will seek to repair the perforation using suture to approximate edges then use falciform ligament as a secound layer to ensure security and prevent postoperative leakage that will lead to peritonitis and death.	Baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Fry DE, Richardson JD, Flint LM Jr. Closure of an acute perforated peptic ulcer with the falciform ligament. Arch Surg. 1978 Oct;113(10):1209-10. doi: 10.1001/archsurg.1978.01370220095016.
• Son TQ, Hoc TH, Huong TT, Long VD, Tung TT, Quyet NC, Panha L, Van Chi N. Outcomes of surgical management of peptic ulcer perforation using the falciform ligament: A cross-sectional study at a single centre in Vietnam. Ann Med Surg (Lond). 2021 Jun 16;67:102477. doi: 10.1016/j.amsu.2021.102477. eCollection 2021 Jul.
• Sung JJ, Kuipers EJ, El-Serag HB. Systematic review: the global incidence and prevalence of peptic ulcer disease. Aliment Pharmacol Ther. 2009 May 1;29(9):938-46. doi: 10.1111/j.1365-2036.2009.03960.x.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 30, 2023
• Primary Completion (Anticipated): October 23, 2026
• Study Completion (Anticipated): November 23, 2026

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Peptic Ulcer; Peptic Ulcer Perforation
• Other Study ID Numbers: Falciform ligament on 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