Risk Factors Affecting Mortality in Perforated Peptic Ulcer | NCT07050199

Studies
Risk Factors Affecting Mortality in Perforated Peptic Ulcer

NCT07050199

Sponsor

Maharajgunj Medical Campus

Status

Completed

Last Update Posted

Jul 3, 2025Actual

Enrollment

85Actual

Phase

Not provided

Conditions

Peptic Ulcers

Interventions

Emergency laparotomy

Countries

Nepal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2022Actual

Primary Completion Date

Mar 30, 2023Actual

Completion Date

Mar 30, 2023Actual

First Submitted Date

Jun 14, 2025

First Submission Date that Met QC Criteria

Jun 24, 2025

First Posted Date

Jul 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2025

Last Update Posted Date

Jul 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

85Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with peptic ulcer perforation of age > 15 years and <75 years			Procedure: Emergency laparotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Emergency laparotomy	Procedure	Emergency laparotomy	Patients with peptic ulcer perforation of age > 15 years and <75 years

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Medical College and Teaching Hospital		Birgunj		44600	Nepal

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010437	Peptic Ulcer

Ancestor Terms

ID	Term
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided