International Multicenter Prospective Transtar Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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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

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Constipation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic constipation - ODS

Adult Patients with ODS

Stapled Transanal Rectal Resection with Contour Transtar

Intervention Type PROCEDURE

Transanal Stapling procedure - Stapled Transanal Rectal Resection

Interventions

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Stapled Transanal Rectal Resection with Contour Transtar

Transanal Stapling procedure - Stapled Transanal Rectal Resection

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No