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Registry With Information About Colitis Ulcerosa and Familial Adenomatous Polyposis Patients (KOPOF)

This study is currently recruiting participants.
Verified March 2012 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01604564
First received: May 21, 2012
Last updated: February 19, 2013
Last verified: March 2012
History of Changes
  Purpose

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.


Condition
Colitis,Ulcerative
Adenomatous Polyposis Coli
Reservoir, Ileoanal

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Evaluation of postoperatieve recovery [ Time Frame: 1 YEAR ] [ Designated as safety issue: No ]
    STANDARD QUESTIONS AT 1, 3, 6 AND 12 MONTHS FU


Estimated Enrollment: 200
Study Start Date: May 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Colitis Ulcerosa
Colitis Ulcerosa With creation of IPAA
Familial Adenomatous Polyposis
Familial Adenomatous Polyposis with creation of IPAA

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Colitis Ulcerosa or Familial Adenomatous Polyposis Patients who have undergone a restorative proctocolectomy with creation of an ileoanal pouche

Criteria

Inclusion Criteria:

  • Colitis Ulcerosa or Familial Adenomatous Polyposis Patients With IPAA

Exclusion Criteria:

  • No
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604564

Contacts
Contact: Isabelle B Terrasson +32 16 340837 isabelle.terrasson@uzleuven.be

Locations
Belgium
University Clinics Gasthuisberg Recruiting
Leuven, Flemish Brabant, Belgium, 3000
Contact: Isabelle B Terrasson     + 32 16 340837     isabelle.terrasson@uzleuven.be    
Contact: Anthony J De Buck Van Overstraeten, MD     + 32 16 340593     anthony.debuckvanoverstraeten@zleuven.be    
Principal Investigator: André JL D'Hoore, PhD            
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: André JL D'Hoore, PhD University Clinics Gasthuisberg Department of Abdominal Surgery
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01604564     History of Changes
Other Study ID Numbers: S-54228
Study First Received: May 21, 2012
Last Updated: February 19, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
Registry
Colitis Ulcerosa (CU)
Familial Adenomatous Polyposis(FAP)
IPAA

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Adenomatous Polyposis Coli
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Adenomatous Polyps
Adenoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Neoplasms
Neoplastic Syndromes, Hereditary
Intestinal Polyposis
Genetic Diseases, Inborn
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013