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CompletedNCT06511921Updated Aug 17, 2025

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

An observational study in Crohn Disease, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-17.

Sponsored by Zagazig University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Crohn Disease

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Keywords

  • perforation
  • biologic therapy
  • ileostomy
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 60 is below the median of 162 across 608 observational studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients with Crohn's disease presented with bowel perforation

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients less than 18 years old
  • well known Crohn's disease patients on medical treatment
  • associated bowel disease as malignancy and diverticulosis.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • post operative Crohn's patients

    Biological: early biologic therapy

  • post operative Cronn's patients

    Biological: late biologic therapy

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

06

What researchers measure

Primary outcomes

  1. size of intra-abdominal fluids or collection

    size of peritoneal fluids will be measured by surface area in centimeter square ( weight x height) using ultrasound

    Time frame: from the first post-operative day to 2 months postoperatively

  2. bowel function

    bowel function will be assessed by hearing intestinal sound using Stethoscope

    Time frame: from the first post-operative day to 2 months postoperatively

  3. fecal fistula

    if found, its amount will be calculated per day using calibrated colostomy bag

    Time frame: from the first post-operative day to 2 months postoperatively

  4. skin maceration

    skin maceration surface area will be calculated by (weight x height) in centimeter square using a ruler

    Time frame: from the first post-operative day to 2 months postoperatively

  5. body weight

    weight gain or weight loss will be measured in kg

    Time frame: from the first post-operative day to 2 months postoperatively

  6. age

    age in years will be recorded

    Time frame: 2 hours before surgery

  7. sex

    sex of patients (male or female) will be recorded

    Time frame: 2 hours before surgery

07

Study locations

1 site
  • Zagazig University Hospitals
    Zagazig, 44519, Egypt
08

References and documents

Individual participant data

Plan to share: No — data will be available on demand by contacting the principle investigator

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06511921
Lead sponsor
Zagazig University
Responsible party
Reham Zakaria Mohamed Ahmed (lecturer of general surgery, Zagazig University) — Principal investigator
First posted
Jul 22, 2024
Start date
Jul 9, 2015
Primary completion
Jul 9, 2025
Completion
Jul 9, 2025
Last update
Aug 17, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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