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OpenTrials
Completed

NCT Number: NCT06511921

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

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zagazig University Hospitals

Zagazig, 44519, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

early biologic therapy

Biological

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

late biologic therapy

Biological

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. body weight

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

    weight gain or weight loss will be measured in kg

  6. age

    Time frame: 2 hours before surgery

    age in years will be recorded

  7. sex

    Time frame: 2 hours before surgery

    sex of patients (male or female) will be recorded

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2024
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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