Clinical Trial: International Multicenter Prospective Transtar Registry

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary: 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.
Sponsor: Ethicon Endo-Surgery (Europe) GmbH

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

Original Primary Outcome: Change in ODS measured by ODS score [ Time Frame: preoperative, at 6 weeks and at 12 months post-op ]

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Changes in patients' perceived severity of 9 symptoms related to ODS measured by individual symptom severity scores [ Time Frame: preoperative, at 6 weeks and 12 months post-op ]

Information By: Ethicon Endo-Surgery (Europe) GmbH

Dates:
Date Received: May 26, 2009
Date Started: January 2009
Date Completion:
Last Updated: April 15, 2014
Last Verified: April 2014