Open Versus Laparoscopic Repair of Perforated Peptic Ulcer

June 12, 2025 updated by: Hussam Fathy Muhammad, Sohag University

Open Versus Laparoscopic Repair of Perforated Peptic Ulcer in Sohag

The aim of this clinical trial is to compare the outcomes of open versus laparoscopic repair for perforated peptic ulcer and provide evidence-based guidance to the selection of the most appropriate operative technique at Sohag University Hospital. The study will include patients presented with perforated peptic ulcers as a complication of peptic ulcer disease during the period of study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ayman M Ahmad, Professor

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients with a clinical diagnosis of perforated peptic ulcer that are fit to undergo surgery either via laparotomy or laparoscopy, males or females, any age, with gastric or duodenal ulcer, with American Society of Anesthesiologists (ASA) grade I, II, III.

Exclusion Criteria:

  • Patients with associated bleeding ulcer (additional steps are needed to control bleeding).
  • Patients with associated pathology other than perforated peptic ulcer.
  • Patients with American Society of Anesthesiologists (ASA) grade IV, V, VI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: open repair of perforated peptic ulcer
group (A) includes patients with perforated peptic ulcer that will be operated by open repair approach
Procedure: open repair of perforated peptic ulcer
group (A) includes patients with perforated peptic ulcer that will be operated by open repair approach
Active Comparator: laparoscopic repair of perforated peptic ulcer
group (B) includes patients with perforated peptic ulcer that will be operated by laparoscopic repair approach
Procedure: laparoscopic repair of perforated peptic ulcer
group (B) includes patients with perforated peptic ulcer that will be operated by laparoscopic repair approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early postoperative follow up for repair of perforated peptic ulcer
Time Frame: 3 days after the operation
resumption of oral intake
3 days after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2024

Primary Completion (Estimated)

June 25, 2025

Study Completion (Estimated)

June 25, 2025

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

June 15, 2025

Last Update Submitted That Met QC Criteria

June 12, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-05-05MS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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