Falciformopexy for Treatment Perforated Peptic Ulcer.

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05715450
Collaborator
(none)
25
1
45.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Falciformopexy for Treatment Perforated Peptic Ulcer
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
CohortCohort
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Falciformopexy for Treatment Perforated Peptic
Anticipated Study Start Date :
Jan 30, 2023
Anticipated Primary Completion Date :
Oct 23, 2026
Anticipated Study Completion Date :
Nov 23, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Falciformopexy for Treatment Perforated Peptic Ulcer [Baseline]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Any cases presented with PPU within age from 18 till 70 years.
Exclusion Criteria:
  • malignancy.

  • Previous GIT and liver surgery.

  • nonoperative treatment.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Principal Investigator: Doaa Hamada Abd elbaset, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Doaa Hamada, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05715450
Other Study ID Numbers:
  • Falciform ligament on PPU
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2023