International Multicenter Prospective Transtar Registry

Completed

• Conditions: Constipation
• Interventions: Procedure: Stapled Transanal Rectal Resection with Contour Transtar

• Registration Number: NCT00909116
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-01-31
• Study First Submitted: 2009-05-26
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Primary Completion: 2012-04-30
• Study Completion: 2012-04-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-10
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic constipation - ODS	Stapled Transanal Rectal Resection with Contour Transtar	Adult Patients with ODS

Primary Outcome Measures

Name	Time	Method
Change in constipation symptoms measured by KESS score	preoperative, and at 12 months post-op

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Andree D'Hoore; 🇧🇪 Leuven, Belgium