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Completed

NCT Number: NCT00909116

International Multicenter Prospective Transtar Registry

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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Key information

Conditions

Constipation Digestive System Diseases Gastrointestinal Diseases Hernia Intestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectocele Signs and Symptoms Signs and Symptoms, Digestive

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Andree D'Hoore

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stapled Transanal Rectal Resection with Contour Transtar

Procedure

Transanal Stapling procedure - Stapled Transanal Rectal Resection

Primary outcomes

  1. Change in constipation symptoms measured by KESS score

    Time frame: preoperative, and at 12 months post-op

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ethicon Endo-Surgery (Europe) GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 27, 2009
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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