Crohn DiseaseNCT06511921
Effect of Biologic Therapy on Surgical Outcomes for Perforated Crohn's Patients
An observational study of Crohn Disease, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- early biologic therapy and late biologic therapy
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jul 2015to 9 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with Crohn's disease presented with bowel perforation
Who may be able to join
- patients at or above 18 years old
- patients with perforated bowel diagnosed as Crohn's disease at presentation underwent surgery
Who cannot join
- patients less than 18 years old
- well known Crohn's disease patients on medical treatment
- associated bowel disease as malignancy and diverticulosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Crohn Disease
- Being tested
- early biologic therapy, late biologic therapy
- Keywords
- perforation, biologic therapy, ileostomy
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early biologic therapyBiological
biologic therapy for perforated Crohn's disease in the early postoperative period
late biologic therapyBiological
no biologic therapy for perforated Crohn's disease up to 2 to3 months in the post operative period
| Study group | Role | What they receive |
|---|---|---|
| post operative Crohn's patients | Not described Receives: Biological: early biologic therapy | |
| post operative Cronn's patients | Not described Receives: Biological: late biologic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from the first post-operative day to 2 months postoperatively
bowel function
bowel function will be assessed by hearing intestinal sound using Stethoscope
Measured: from the first post-operative day to 2 months postoperatively
fecal fistula
if found, its amount will be calculated per day using calibrated colostomy bag
Measured: from the first post-operative day to 2 months postoperatively
skin maceration
skin maceration surface area will be calculated by (weight x height) in centimeter square using a ruler
Measured: from the first post-operative day to 2 months postoperatively
body weight
weight gain or weight loss will be measured in kg
Measured: from the first post-operative day to 2 months postoperatively
age
age in years will be recorded
Measured: 2 hours before surgery
sex
sex of patients (male or female) will be recorded
Measured: 2 hours before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start9 Jul 2015
- Primary completion9 Jul 2025
- Study completion9 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reham Zakaria Mohamed Ahmed, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511921
- Sponsor's protocol ID
- #479\9-July-2024
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be available on demand by contacting the principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Biologic Therapy for Post-operative Perforated Crohn's Disease Patients
- ClinicalTrials.gov ID
- NCT06511921
- Acronym / sponsor ID
- #479\9-July-2024
- Conditions
- Crohn Disease
- Keywords
- perforation, biologic therapy, ileostomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 9 Jul 2015 (actual)
- Primary completion
- 9 Jul 2025 (actual)
- Study completion
- 9 Jul 2025 (actual)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| post operative Crohn's patients | – | Biological: early biologic therapy |
| post operative Cronn's patients | – | Biological: late biologic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with Crohn's disease presented with bowel perforation
Key inclusion criteria (2 listed)
- patients at or above 18 years old
- patients with perforated bowel diagnosed as Crohn's disease at presentation underwent surgery
Key exclusion criteria (3 listed)
- patients less than 18 years old
- well known Crohn's disease patients on medical treatment
- associated bowel disease as malignancy and diverticulosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early biologic therapybiologic therapy for perforated Crohn's disease in the early postoperative period | Biological | post operative Crohn's patients |
| late biologic therapyno biologic therapy for perforated Crohn's disease up to 2 to3 months in the post operative period | Biological | post operative Cronn's patients |
Primary outcome
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
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
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
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
body weight
Time frame: from the first post-operative day to 2 months postoperatively
weight gain or weight loss will be measured in kg
age
Time frame: 2 hours before surgery
age in years will be recorded
sex
Time frame: 2 hours before surgery
sex of patients (male or female) will be recorded
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No. data will be available on demand by contacting the principle investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
size of intra-abdominal fluids or collection (time frame: from the first post-operative day to 2 months postoperatively). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.