International Multicenter Prospective Transtar Registry

Ethicon

Status: Completed

Conditions: Constipation

Treatments: Procedure: Stapled Transanal Rectal Resection with Contour Transtar

Study type: Observational

Funder types: Industry

Identifiers

NCT00909116

CME-08-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Chronic constipation - ODS

Description:

Adult Patients with ODS

Treatment:

Procedure: Stapled Transanal Rectal Resection with Contour Transtar