International Multicenter Prospective Transtar Registry

August 10, 2017 updated by: Ethicon Endo-Surgery (Europe) GmbH

International Transtar Registry - Stapled Transanal Rectal Resection Performed With Contour Transtar Stapler in the Treatment of Obstructed Defecation Syndrome (ODS)

Obstructed Defecation Syndrome (ODS) describes a condition which is characterized by chronic constipation. The symptoms of ODS include abdominal pain or cramping, irregular bowel frequency and the feeling of not having emptied the rectum. ODS is usually associated with internal rectal prolapse and/or rectocele. For surgical treatment of ODS, a plethora of surgical techniques have been described with no one method having been assessed as a gold standard.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A new surgical procedure - Transtar - has been introduced in Europe recently. The goal of this registry is to assess safety, effectiveness and patient quality of life, associated with Transtar for chronic constipation due to morphological changes, such as internal rectal prolapse and rectocele.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Andree D'Hoore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive male and female patients of at least 16 years with symptoms of chronic constipation due to ODS associated with anatomical changes, such as internal rectal prolapse and rectocele

Description

Inclusion Criteria:

  • Patients with obstructed defecation, fragmented defecation or incomplete evacuation as a presenting symptom documented by a standardized symptom score
  • confirmed internal rectal prolapse or rectocele on dynamic defecography
  • adequate external sphincter on rectal digital examination.

Exclusion Criteria:

  • Subjects with any other surgical procedure than STARR for ODS
  • Subjects in whom STARR is not performed with the Contour Transtar stapler
  • Subjects with a physical or psychological condition which would impair participation in the registry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic constipation - ODS
Adult Patients with ODS
Procedure: Stapled Transanal Rectal Resection with Contour Transtar
Transanal Stapling procedure - Stapled Transanal Rectal Resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in constipation symptoms measured by KESS score
Time Frame: preoperative, and at 12 months post-op
preoperative, and at 12 months post-op

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in patients symptoms measured by Incontinence score and ODS Score, QoL measures with EQ5D and PAC-QoL
Time Frame: preoperative, at 6 weeks and 12 months post-op
preoperative, at 6 weeks and 12 months post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethicon Endo-Surgery (Europe) GmbH

Investigators

  • Study Director: Goran Ribaric, MD,PhD, Ethicon Endo-Surgery (Europe) GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 31, 2009

Primary Completion (ACTUAL)

April 30, 2012

Study Completion (ACTUAL)

April 30, 2012

Study Registration Dates

First Submitted

May 26, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (ESTIMATE)

May 27, 2009

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 10, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CME-08-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

via publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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