Registry With Information About Colitis Ulcerosa and Familial Adenomatous Polyposis Patients | oneFAPvoice

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Registry With Information About Colitis Ulcerosa and Familial Adenomatous Polyposis Patients

study id #: NCT01604564

condition: Colitis, Ulcerative; Adenomatous Polyposis Coli; Reservoir, Ileoanal

status: active, not recruiting

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.

start date: May 2012

estimated completion: December 2019

last updated: October 16, 2018

size / enrollment: 200

study design: Observational Model: Cohort
Time Perspective: Prospective

study 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.

primary outcomes:

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

inclusion criteria:

• Eligible Sexes:

Colitis Ulcerosa or Familial Adenomatous Polyposis Patients With IPAA

exclusion criteria:

sponsor: Universitaire Ziekenhuizen Leuven

investigators: André JL D'Hoore, PhD

trial center locations: Belgium

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