Predictors of Morbidity in Perforation Peritonitis: A Pro... | NCT07047911

Studies
Predictors of Morbidity in Perforation Peritonitis: A Prospective Observational Study From a Tertiary Care Centre in North India

NCT07047911

Sponsor

Government Medical College, Patiala

Status

Completed

Last Update Posted

Jul 2, 2025Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Peritonitis Infectious, Gastrointestinal Perforation, Surgical Infection, Postoperative Complications

Interventions

Observational only - surgical management not assigned by study

Countries

Not provided

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

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

Mar 10, 2014Actual

Primary Completion Date

Mar 1, 2016Actual

Completion Date

May 10, 2016Actual

First Submitted Date

Jun 24, 2025

First Submission Date that Met QC Criteria

Jun 24, 2025

First Posted Date

Jul 2, 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 2, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lakshay Singla, Doctor, Government Medical College, PatialaPrincipal Investigator

Lead Sponsor

Government Medical College, PatialaOTHER_GOV

Collaborators

Not provided

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

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.

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

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational only - surgical management not assigned by study	Other	Observational only - surgical management not assigned by study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post operative morbidity		30days
Post operative morbidity		30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms