Falciformopexy for Treatment Perforated Peptic Ulcer.

Perforated Peptic Ulcer Clinical Trial

Official title:

Falciformopexy for Treatment Perforated Peptic

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05715450
• Other study ID #: Falciform ligament on PPU
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 30, 2023
• Est. completion date: November 23, 2026

Study information

• Verified date: March 2023
• Source: Assiut University
• Contact: Doaa Hamada Abd elbaset
• Phone: 01028971942
• Email: dhamada755[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: November 23, 2026
• Est. primary completion date: October 23, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• malignancy.

• Previous GIT and liver surgery.

• nonoperative treatment.

Related Conditions & MeSH terms

• Peptic Ulcer
• Peptic Ulcer Perforation
• Perforated Peptic Ulcer

Intervention

Procedure:
• Falciformopexy for Treatment Perforated Peptic Ulcer
use the falciform ligament on perforated peptic ulcer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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