International Multicenter Prospective Transtar Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00909116
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : August 11, 2017
Information provided by (Responsible Party):
Ethicon Endo-Surgery (Europe) GmbH

Brief Summary:
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.

Condition or disease Intervention/treatment
Constipation Procedure: Stapled Transanal Rectal Resection with Contour Transtar

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
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Transtar Registry - Stapled Transanal Rectal Resection Performed With Contour Transtar Stapler in the Treatment of Obstructed Defecation Syndrome (ODS)
Actual Study Start Date : January 31, 2009
Actual Primary Completion Date : April 30, 2012
Actual Study Completion Date : April 30, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Change in constipation symptoms measured by KESS score [ Time Frame: preoperative, and at 12 months post-op ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00909116

Andree D`Hoore
Leuven, Belgium, 3000
Sponsors and Collaborators
Ethicon Endo-Surgery (Europe) GmbH
Study Director: Goran Ribaric, MD,PhD Ethicon Endo-Surgery (Europe) GmbH

Responsible Party: Ethicon Endo-Surgery (Europe) GmbH Identifier: NCT00909116     History of Changes
Other Study ID Numbers: CME-08-001
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: via publication
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Ethicon Endo-Surgery (Europe) GmbH:
chronic constipation
internal rectal prolapse
Stapled Transanal Rectal Resection
Contour Transtar

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms