Effect of Biologic Therapy on Surgical Outcomes for Perforated Crohn's Patients

August 12, 2025 updated by: Reham Zakaria Mohamed Ahmed, Zagazig University

Early Versus Late Biologic Therapy for Post-operative Perforated Crohn's Disease Patients

crohn's disease patients who present by intestinal perforation as the first presentation are hard to deal with. Surgical techniques as anastmosis or diversion stoma and active course of the disease may greatly affect the quality of life. In post-operative period, is the priority to avoid the post operative complications and to improve surgical outcomes or to stop active course of the disease and to induce remission?. So, those patients were classified into two groups. one group received biological therapy early post operative and the other group received it 2 or 3 months later after surgery and the investigators will compare results between the two groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Phase

  • Early Phase 1

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
      • Zagazig, Egypt, 44519
        • Zagazig University Hospitals

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patients with Crohn's disease presented with bowel perforation

Description

Inclusion Criteria:

  • patients at or above 18 years old
  • patients with perforated bowel diagnosed as Crohn's disease at presentation underwent surgery

Exclusion Criteria:

  • patients less than 18 years old
  • well known Crohn's disease patients on medical treatment
  • associated bowel disease as malignancy and diverticulosis.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
post operative Crohn's patients
Biological: early biologic therapy
biologic therapy for perforated Crohn's disease in the early postoperative period
post operative Cronn's patients
Biological: late biologic therapy
no biologic therapy for perforated Crohn's disease up to 2 to3 months in the post operative period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
size of intra-abdominal fluids or collection
Time Frame: from the first post-operative day to 2 months postoperatively
size of peritoneal fluids will be measured by surface area in centimeter square ( weight x height) using ultrasound
from the first post-operative day to 2 months postoperatively
bowel function
Time Frame: from the first post-operative day to 2 months postoperatively
bowel function will be assessed by hearing intestinal sound using Stethoscope
from the first post-operative day to 2 months postoperatively
fecal fistula
Time Frame: from the first post-operative day to 2 months postoperatively
if found, its amount will be calculated per day using calibrated colostomy bag
from the first post-operative day to 2 months postoperatively
skin maceration
Time Frame: from the first post-operative day to 2 months postoperatively
skin maceration surface area will be calculated by (weight x height) in centimeter square using a ruler
from the first post-operative day to 2 months postoperatively
body weight
Time Frame: from the first post-operative day to 2 months postoperatively
weight gain or weight loss will be measured in kg
from the first post-operative day to 2 months postoperatively
age
Time Frame: 2 hours before surgery
age in years will be recorded
2 hours before surgery
sex
Time Frame: 2 hours before surgery
sex of patients (male or female) will be recorded
2 hours before surgery

Collaborators and Investigators

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

Sponsor

Zagazig University

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)

July 9, 2015

Primary Completion (Actual)

July 9, 2025

Study Completion (Actual)

July 9, 2025

Study Registration Dates

First Submitted

July 12, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #479\9-July-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data will be available on demand by contacting the principle investigator

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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