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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01604564
Other study ID # S-54228
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2012
Est. completion date January 2019

Study information

Verified date October 2021
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 207
Est. completion date January 2019
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Colitis Ulcerosa or Familial Adenomatous Polyposis Patients With IPAA Exclusion Criteria: - No

Study Design


Locations

Country Name City State
Belgium University Clinics Gasthuisberg Leuven Flemish Brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of postoperatieve recovery STANDARD QUESTIONS AT 1, 3, 6 AND 12 MONTHS FU 1 YEAR
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