International Multicenter Prospective Transtar Registry

Study Overview
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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.

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.

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

Conditions
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Constipation

Intervention / Treatment
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* Procedure: Stapled Transanal Rectal Resection with Contour Transtar


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic constipation - ODS<br>Adult Patients with ODS | Procedure: Stapled Transanal Rectal Resection with Contour Transtar<br>* Transanal Stapling procedure - Stapled Transanal Rectal Resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in constipation symptoms measured by KESS score |  | preoperative, and at 12 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ODS, chronic constipation, internal rectal prolapse, rectocele, Stapled Transanal Rectal Resection, Contour Transtar, STARR