Registry With Information About Colitis Ulcerosa and Fami... | NCT01604564

Studies
Registry With Information About Colitis Ulcerosa and Familial Adenomatous Polyposis Patients

NCT01604564

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Oct 14, 2021Actual

Enrollment

207Actual

Phase

Not provided

Conditions

Colitis,Ulcerative
Adenomatous Polyposis Coli
Reservoir, Ileoanal

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Jul 2018Actual

Completion Date

Jan 2019Actual

First Submitted Date

May 21, 2012

First Submission Date that Met QC Criteria

May 21, 2012

First Posted Date

May 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2021

Last Update Posted Date

Oct 14, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

207Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Colitis Ulcerosa		Colitis Ulcerosa With creation of IPAA
Familial Adenomatous Polyposis		Familial Adenomatous Polyposis with creation of IPAA

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of postoperatieve recovery	STANDARD QUESTIONS AT 1, 3, 6 AND 12 MONTHS FU	1 YEAR

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Colitis Ulcerosa or Familial Adenomatous Polyposis Patients With IPAA

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
André JL D'Hoore, PhD	University Clinics Gasthuisberg Department of Abdominal Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinics Gasthuisberg		Leuven	Flemish Brabant	3000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative
D011125	Adenomatous Polyposis Coli

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided