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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven Identifier:
First received: May 21, 2012
Last updated: July 28, 2016
Last verified: July 2016
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.

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:

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 ]

Estimated Enrollment: 200
Study Start Date: May 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   Child, Adult, Senior
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

Inclusion Criteria:

  • Colitis Ulcerosa or Familial Adenomatous Polyposis Patients With IPAA

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01604564

Contact: Isabelle B Terrasson +32 16 340837

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

Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT01604564     History of Changes
Other Study ID Numbers: S-54228 
Study First Received: May 21, 2012
Last Updated: July 28, 2016
Health Authority: Belgium: Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Colitis, Ulcerative
Adenomatous Polyposis Coli
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Rectal Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Inflammatory Bowel Diseases
Adenomatous Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Intestinal Polyposis processed this record on October 27, 2016