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

This study is currently recruiting participants.
Verified July 2016 by Universitaire Ziekenhuizen Leuven
Sponsor:
ClinicalTrials.gov Identifier:
NCT01604564
First Posted: May 23, 2012
Last Update Posted: July 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
  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:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Evaluation of postoperatieve recovery [ Time Frame: 1 YEAR ]
    STANDARD QUESTIONS AT 1, 3, 6 AND 12 MONTHS FU


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)
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01604564     History of Changes
Other Study ID Numbers: S-54228
First Submitted: May 21, 2012
First Posted: May 23, 2012
Last Update Posted: July 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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