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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06511921
Enrollment
60
Registered
2024-07-22
Start date
2015-07-09
Completion date
2025-07-09
Last updated
2025-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Keywords

perforation, biologic therapy, ileostomy

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 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.

Interventions

BIOLOGICALearly biologic therapy

biologic therapy for perforated Crohn's disease in the early postoperative period

BIOLOGICALlate biologic therapy

no biologic therapy for perforated Crohn's disease up to 2 to3 months in the post operative period

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
size of intra-abdominal fluids or collectionfrom the first post-operative day to 2 months postoperativelysize of peritoneal fluids will be measured by surface area in centimeter square ( weight x height) using ultrasound
bowel functionfrom the first post-operative day to 2 months postoperativelybowel function will be assessed by hearing intestinal sound using Stethoscope
fecal fistulafrom the first post-operative day to 2 months postoperativelyif found, its amount will be calculated per day using calibrated colostomy bag
skin macerationfrom the first post-operative day to 2 months postoperativelyskin maceration surface area will be calculated by (weight x height) in centimeter square using a ruler
body weightfrom the first post-operative day to 2 months postoperativelyweight gain or weight loss will be measured in kg
age2 hours before surgeryage in years will be recorded
sex2 hours before surgerysex of patients (male or female) will be recorded

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026