Risk Factors Affecting Mortality in Perforated Peptic Ulcer

NCT07050199 | Completed

• 1 other identifier: PG-NMC/528/078-079
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Perforation is one of the most severe and life-threatening complications of peptic ulcer disease. This study aims to evaluate the risk factors associated with postoperative morbidity and mortality in patients undergoing surgery for peptic ulcer perforation, with a focus on the timing of presentation, demographic variables, surgical delay, and their association with postoperative outcomes.

Conditions

Peptic Ulcers

Outcome Measures

Primary Outcomes (2)

• Postoperative Morbidity Rate

  Incidence of postoperative complications (e.g., wound infection, sepsis, anastomotic leak, pneumonia) in patients undergoing surgery for perforated peptic ulcer.

  12 months (from patient enrollment to completion of follow-up)

• Postoperative Mortality Rate

  Incidence of death following surgical intervention for perforated peptic ulcer.

  12 months (from patient enrollment to completion of follow-up)

Study Arms (1)

Patients with peptic ulcer perforation of age > 15 years and <75 years

Procedure: Emergency laparotomy

Interventions

Emergency laparotomy PROCEDURE

Emergency laparotomy

Patients with peptic ulcer perforation of age > 15 years and <75 years

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing emergency laparotomy for peptic ulcer perforation with Graham's patch repair

You may qualify if:

• Patients with peptic ulcer perforation aged\> 15 years and \<75 years.
• Patients with duodenal or gastric perforation of peptic ulcer origin.
• Patients who underwent simple closure with omental patch as a standard operative procedure.

You may not qualify if:

• Patients treated with conservative management.
• Patients with perforation of peptic ulcer origin at the jejunum, ileum adjacent to Meckel's diverticulum.
• Patients presenting with recurrent perforation or stomal ulcer perforation.

Sponsors & Collaborators

• Maharajgunj Medical Campus: lead

Study Sites (1)

National Medical College and Teaching Hospital

Birgunj, 44600, Nepal

Location

MeSH Terms

Conditions

Peptic Ulcer

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-investigator

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: July 3, 2025
• Study Start: April 1, 2022
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)