Open Versus Laparoscopic Repair of Perforated Peptic Ulcer

Sohag University

Status: Enrolling

Conditions: Perforated Peptic Ulcer

Treatments: Procedure: open repair of perforated peptic ulcer; Procedure: laparoscopic repair of perforated peptic ulcer

Study type: Interventional

Funder types: Other

Identifiers

NCT06484699

Soh-Med-24-05-05MS

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

open repair of perforated peptic ulcer

Active Comparator group

Description:

group (A) includes patients with perforated peptic ulcer that will be operated by open repair approach

Treatment:

Procedure: open repair of perforated peptic ulcer

laparoscopic repair of perforated peptic ulcer

Active Comparator group

Description:

group (B) includes patients with perforated peptic ulcer that will be operated by laparoscopic repair approach

Treatment:

Procedure: laparoscopic repair of perforated peptic ulcer