International Multicenter Prospective Transtar Registry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery (Europe) GmbH
ClinicalTrials.gov Identifier:
NCT00909116
First received: May 26, 2009
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Constipation
Procedure: Stapled Transanal Rectal Resection with Contour Transtar

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Transtar Registry - Stapled Transanal Rectal Resection Performed With Contour Transtar Stapler in the Treatment of Obstructed Defecation Syndrome (ODS)

Resource links provided by NLM:


Further study details as provided by Ethicon Endo-Surgery (Europe) GmbH:

Primary Outcome Measures:
  • Change in constipation symptoms measured by KESS score [ Time Frame: preoperative, and at 12 months post-op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chronic constipation - ODS
Adult Patients with ODS
Procedure: Stapled Transanal Rectal Resection with Contour Transtar
Transanal Stapling procedure - Stapled Transanal Rectal Resection

Detailed 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Consecutive male and female patients of at least 16 years with symptoms of chronic constipation due to ODS associated with anatomical changes, such as internal rectal prolapse and rectocele

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909116

Locations
Belgium
Andree D`Hoore
Leuven, Belgium, 3000
Sponsors and Collaborators
Ethicon Endo-Surgery (Europe) GmbH
Investigators
Study Director: Goran Ribaric, MD,PhD Ethicon Endo-Surgery (Europe) GmbH
  More Information

Publications:
Responsible Party: Ethicon Endo-Surgery (Europe) GmbH
ClinicalTrials.gov Identifier: NCT00909116     History of Changes
Other Study ID Numbers: CME-08-001
Study First Received: May 26, 2009
Last Updated: April 15, 2014
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by Ethicon Endo-Surgery (Europe) GmbH:
ODS
chronic constipation
internal rectal prolapse
rectocele
Stapled Transanal Rectal Resection
Contour Transtar
STARR

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 11, 2014