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

Early Phase 1

Active, not recruiting

• Conditions: Crohn Disease
• Interventions: Biological: early biologic therapy; Biological: late biologic therapy

• Registration Number: NCT06511921
• Lead Sponsor: Zagazig University

Brief Summary

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 will receive biological therapy early post operative and the other group will receive it 2 or 3 months later after surgery and the investigators will compare results between the two groups.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-09
• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-19
• Last Update Submitted: 2024-07-19
• Study First Posted: 2024-07-22
• Last Update Posted: 2024-07-23
• Primary Completion: 2025-07-09
• Study Completion: 2025-07-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
post operative Crohn's patients	early biologic therapy	-
post operative Cronn's patients	late biologic therapy	-

Primary Outcome Measures

Name	Time	Method
fecal fistula	from the first post-operative day to 2 months postoperatively	if found, its amount will be calculated per day using calibrated colostomy bag
size of intra-abdominal fluids or collection	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
bowel function	from the first post-operative day to 2 months postoperatively	bowel function will be assessed by hearing intestinal sound using Stethoscope
sex	2 hours before surgery	sex of patients (male or female) will be recorded
skin maceration	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
body weight	from the first post-operative day to 2 months postoperatively	weight gain or weight loss will be measured in kg
age	2 hours before surgery	age in years will be recorded

Trial Locations

Locations (1)

Zagazig University Hospitals; 🇪🇬 Zagazig, Egypt