NCT07047911

Brief Summary

This is a prospective observational cohort study conducted at a tertiary care hospital in North India. The study aims to evaluate clinical and biochemical predictors of postoperative morbidity in patients undergoing emergency laparotomy for gastrointestinal perforation peritonitis. Data on patient demographics, comorbidities, surgical timing, renal function, and complications were collected and analyzed to identify factors associated with increased morbidity. The findings are expected to support early risk stratification and improved clinical management of surgical emergencies.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2016

Completed
9.1 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2025

Completed
Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

June 24, 2025

Last Update Submit

June 24, 2025

Conditions

Peritonitis Infectious, Gastrointestinal Perforation, Surgical Infection, Postoperative Complications

Outcome Measures

Primary Outcomes (2)

  • Post operative morbidity

    30days

  • Post operative morbidity

    30 days

Interventions

Observational only - surgical management not assigned by studyOTHER

Observational only - surgical management not assigned by study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 50 adult patients were enrolled prospectively over a 2-year period at Government Medical College \& Rajindra Hospital, Patiala.

You may qualify if:

  • Adults (\>18 years) with gastrointestinal perforation-induced peritonitis

You may not qualify if:

  • Primary peritonitis, anastomotic leaks, refusal of surgery, or patients discharged against medical advice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 24, 2025

First Posted

July 2, 2025

Study Start

March 10, 2014

Primary Completion

March 1, 2016

Study Completion

May 10, 2016

Last Updated

July 2, 2025

Record last verified: 2025-06