NCT00909116

International Multicenter Prospective Transtar Registry

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Ethicon Endo-Surgery (Europe) GmbH · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Constipation

Interventions

Type	Name	Description
PROCEDURE	Stapled Transanal Rectal Resection with Contour Transtar	Transanal Stapling procedure - Stapled Transanal Rectal Resection

Timeline

• Start date: 2009-01-31
• Primary completion: 2012-04-30
• Completion: 2012-04-30
• First posted: 2009-05-27
• Last updated: 2017-08-11

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated device study