Colitis,UlcerativeKOPOFNCT01604564
Registry With Information About Colitis Ulcerosa and Familial Adenomatous Polyposis Patients
An observational study of Colitis,Ulcerative and Adenomatous Polyposis Coli, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The purpose of this registry is to collect information about patients in which a pouch has been created to improve in the future the quality of the surgery of the pouch. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colitis,Ulcerative, Adenomatous Polyposis Coli, Reservoir, Ileoanal
- How many people
- 207 participants
- Where
- 1 siteBelgium
- Study dates
- May 2012to Jan 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Colitis Ulcerosa or Familial Adenomatous Polyposis Patients who have undergone a restorative proctocolectomy with creation of an ileoanal pouche
Who may be able to join
- Colitis Ulcerosa or Familial Adenomatous Polyposis Patients With IPAA
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
About this study
Official title: KOPOF Registry (Patients Characteristics, Operative Data, Postoperative Outcome, Functional Postoperative Recovery ) of Patients in Which a Pouch Has Been Created Due to Colitis Ulcerosa (CU) or Familial Adenomatous Polyposis(FAP)
The purpose of this registry is to collect information about patients in which a pouch has been created to improve in the future the quality of the surgery of the pouch.
Read the detailed description
To improve the quality of the surgery of the pouch created in CU and FAP patients, the following information will be collected: Patients Characteristics, Operative Data, Postoperative Outcome and Functional Postoperative Recovery.
- Keywords
- Registry, Colitis Ulcerosa (CU), Familial Adenomatous Polyposis(FAP), IPAA
- Medical subject headings
- Colitis, Ulcerative, Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Colitis Ulcerosa | Colitis Ulcerosa With creation of IPAA | |
| Familial Adenomatous Polyposis | Familial Adenomatous Polyposis with creation of IPAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of postoperatieve recovery
STANDARD QUESTIONS AT 1, 3, 6 AND 12 MONTHS FU
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis,UlcerativeStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André JL D'Hoore, PhD, Principal investigator, University Clinics Gasthuisberg Department of Abdominal Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604564
- Sponsor's protocol ID
- S-54228
- Acronym
- KOPOF
- Status last verified
- Oct 2021
- First submitted
- 21 May 2012
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KOPOF Registry (Patients Characteristics, Operative Data, Postoperative Outcome, Functional Postoperative Recovery ) of Patients in Which a Pouch Has Been Created Due to Colitis Ulcerosa (CU) or Familial Adenomatous Polyposis(FAP)
- ClinicalTrials.gov ID
- NCT01604564
- Acronym / sponsor ID
- KOPOF / S-54228
- Keywords
- Registry, Colitis Ulcerosa (CU), Familial Adenomatous Polyposis(FAP), IPAA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 23 May 2012 (estimated)
- 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.
The purpose of this registry is to collect information about patients in which a pouch has been created to improve in the future the quality of the surgery of the pouch.
Detailed description
To improve the quality of the surgery of the pouch created in CU and FAP patients, the following information will be collected: Patients Characteristics, Operative Data, Postoperative Outcome and Functional Postoperative Recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colitis Ulcerosa | – | –Colitis Ulcerosa With creation of IPAA |
| Familial Adenomatous Polyposis | – | –Familial Adenomatous Polyposis with creation of IPAA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Colitis Ulcerosa or Familial Adenomatous Polyposis Patients who have undergone a restorative proctocolectomy with creation of an ileoanal pouche
Key inclusion criteria (1 listed)
- Colitis Ulcerosa or Familial Adenomatous Polyposis Patients With IPAA
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of postoperatieve recovery
Time frame: 1 YEAR
STANDARD QUESTIONS AT 1, 3, 6 AND 12 MONTHS FU
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 14 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Colitis,Ulcerative
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
André JL D'Hoore, PhD principal investigator
University Clinics Gasthuisberg Department of Abdominal Surgery
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 Colitis,Ulcerative and Adenomatous Polyposis Coli, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 inclusion and 1 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 14 Oct 2021. 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 Belgium. 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?
Evaluation of postoperatieve recovery (time frame: 1 YEAR). 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 14 Oct 2021.