NCT02110862

Brief Summary

The aim of this study is to evaluate scintigraphic methods as objective factors for functional outcome in patients treated with ileal-pouch-anal anastomosis (IPAA). The gastrointestinal transit-time and the degree of evacuation are evaluated in relation to the functional outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

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

January 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

1.6 years

First QC Date

April 30, 2013

Last Update Submit

January 27, 2016

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal transit-time

    The small bowel transittime until food is in the IPAA

    12 weeks

Study Arms (1)

Ulcerative colitis patients with ileal-pouch-anal anastomosis

Other: Transittime. Defecography

Interventions

Transittime. DefecographyOTHER
Ulcerative colitis patients with ileal-pouch-anal anastomosis

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Ulcerative colitis

You may qualify if:

  • Ulcerative colitis patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, Denmark

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Mie Kjaer

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 30, 2013

First Posted

April 10, 2014

Study Start

January 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

DK(1)