Open vs Laparoscopic Repair of Perforated Peptic Ulcer

July 4, 2025 updated by: Mina Magdy Dawood, Assiut University

Comparison Between Open vs Laparoscopic Repair of Perforated Peptic Ulcer

comparison between outcomes of both open and laparoscopic repair of perforated peptic ulcer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

With the advent of proton pump inhibitors and Helicobacter pylori (H. pylori) eradication therapy, surgical intervention for peptic ulcer disease (PUD) is limited to perforated ulcers in the emergent setting. Perforation is an acute life threatening complication of PUD and occurs in nearly 20% of cases of duodenal ulcer patients . Perforation is a common complication of PUD, with an average 2-14% of peptic ulcers resulting in perforation .While bleeding is the most frequent complication of PUD, perforation carries a higher rate of surgical intervention and is the most lethal complication, associated with a 30-days mortality risk ranging from 3-40%, with advanced age, higher American Society of Anesthesiologists (ASA) classification , elevated body mass index (BMI), and perforation diameter being non-modifiable risk factors associated with increased mortality .The only modifiable risk factor associated with mortality is time to operation, whereby a delay of more than three hours is associated with a doubling of mortality risk .In the 1990s, laparoscopic repair of PPUs was first described . Laparoscopy allows for minimally invasive detection and closure of the lesion with adequate peritoneal lavage, without the drawbacks of an upper laparotomy .Less postoperative pain and analgesic consumption, shorter recovery durations, and decreased wound infections are just some of the advantages of laparoscopic repair . The choice of surgical technique, laparoscopy versus laparotomy, varies depending on the patient's preoperative clinical status, surgeon expertise/preference, and location of defect, with the goal of short operative time. It has been widely reported that open abdominal surgery increases postoperative pain and is associated with higher morbidity (ventral incisional hernia rate, surgical site infection, postoperative respiratory compromise, delayed recovery times, and dehiscence) when compared to laparoscopic surgery . Laparoscopy allows for minimally invasive detection and closure of the lesion with adequate peritoneal lavage, without the drawbacks of an upper laparotomy. Less postoperative pain and analgesic consumption, shorter recovery durations, and decreased wound infections are just some of the advantages of laparoscopic repair .Despite these favorable outcomes, laparoscopic repair is less commonly used, owning to longer operative times in less experienced centers, higher incidence of reoperations owning to leakage at the repair site, and higher incidence of intraabdominal fluid collections secondary to inadequate lavage and the requirement of extensive surgical skill . Additionally, others point to laparotomy as the better treatment, especially for repairing ulcers larger than 9 mm.

Study Type

Interventional

Enrollment (Actual)

40

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 Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut University Hospital

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

17 years to 69 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients older than 16 years old and younger than 70 years old.
  • Patients presenting with acute abdomen due to perforated peptic ulcer
  • Patients eligible for laparoscopic surgeries

Exclusion Criteria:

  • Patients younger than 16 years old and older than 70 years old
  • Contraindications to laparoscopic surgeries as (Hemodynamic instability/shock, Acute intestinal obstruction with dilated bowel loops, Increased intracranial pressure, Relative contraindications, Cardiac failure, Pulmonary failure, Pregnancy/large pelvic masses, Soft tissue infection at port sites, Expected (extensive) adhesions from a previous abdominal surgery)
  • Patients who absconded or left the study or died during the period of study.
  • Patients with a surgical diagnosis other than perforated peptic ulcer

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 approach for perforated pectic ulcer
repair of perforated peptic ulcer by open technique (exploration)
Procedure: open repair(exploration)
repair of defect of perforated peptic ulcer and peritoneal decontamination by exploration
Active Comparator: lap. approach for perforated peptic ulcer
repair of perforated peptic ulcer by laparoscopy
Procedure: abdominal laparoscopy
repair of defect of perforated peptic ulcer and peritoneal decontamination by laparoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
short term outcomes of both open and lap. Repair of perforated peptic ulcer; operative time
Time Frame: baseline
comparison of operative time of both laparoscopic and open surgical repair of perforated peptic ulcer
baseline
short term outcomes of both open and lap. Repair of perforated peptic ulcer; repair site leakage
Time Frame: baseline
comparison of repair site leakage between both lap. and open surgical repair of perforated peptic ulcer by follow up through drains inspection.
baseline
short term outcomes of both open and lap. Repair of perforated peptic ulcer; intra-abdominal abscess
Time Frame: baseline
comparison of intra-abdominal abscess formation between both lap. and open surgical repair of perforated peptic ulcer by follow up through abdominal ultrasonography.
baseline
short term outcomes of both open and lap. Repair of perforated peptic ulcer; surgical site infection
Time Frame: baseline
comparison of surgical site infection between both lap. and open surgical repair of perforated peptic ulcer through daily dressing and wound inspection for signs of inflammation.
baseline
short term outcomes of both open and lap. Repair of perforated peptic ulcer; postoperative ileus
Time Frame: baseline
comparison of postoperative ileus between both lap. and open surgical repair of perforated peptic ulcer by follow up of bowel movements.
baseline
short term outcomes of both open and lap. Repair of perforated peptic ulcer; hospital stay
Time Frame: baseline
comparison of duration of patient's hospital stay between both lap. and open surgical repair of perforated peptic ulcer.
baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: Mahmoud Mohamed, Mch, Assiut University Hospitals
  • Study Director: Mostafa Sayed, Mch, Assiut University Hospitals
  • Study Director: Ibrahim Mostafa, Mch, Assiut University Hospitals

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)

September 15, 2023

Primary Completion (Actual)

September 15, 2024

Study Completion (Actual)

September 15, 2024

Study Registration Dates

First Submitted

December 24, 2022

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 4, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • repair of 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

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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