NCT01604564

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

6.2 years

First QC Date

May 21, 2012

Last Update Submit

October 13, 2021

Conditions

Colitis,UlcerativeAdenomatous Polyposis ColiReservoir, Ileoanal

Keywords

RegistryColitis Ulcerosa (CU)Familial Adenomatous Polyposis(FAP)IPAA

Outcome Measures

Primary Outcomes (1)

  • Evaluation of postoperatieve recovery

    STANDARD QUESTIONS AT 1, 3, 6 AND 12 MONTHS FU

    1 YEAR

Study Arms (2)

Colitis Ulcerosa

Colitis Ulcerosa With creation of IPAA

Familial Adenomatous Polyposis

Familial Adenomatous Polyposis with creation of IPAA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Colitis Ulcerosa or Familial Adenomatous Polyposis Patients With IPAA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinics Gasthuisberg

Leuven, Flemish Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Colitis, UlcerativeAdenomatous Polyposis Coli

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal DiseasesAdenomatous PolypsAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryIntestinal PolyposisGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • André JL D'Hoore, PhD

    University Clinics Gasthuisberg Department of Abdominal Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 23, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2018

Study Completion

January 1, 2019

Last Updated

October 14, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)