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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: September 19, 2012
Last verified: September 2012
History of Changes

May 26, 2009
September 19, 2012
January 2009
April 2012   (final data collection date for primary outcome measure)
Change in constipation symptoms measured by KESS score [ Time Frame: preoperative, and at 12 months post-op ] [ Designated as safety issue: No ]
Change in ODS measured by ODS score [ Time Frame: preoperative, at 6 weeks and at 12 months post-op ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00909116 on ClinicalTrials.gov Archive Site
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 ]
Changes in patients' perceived severity of 9 symptoms related to ODS measured by individual symptom severity scores [ Time Frame: preoperative, at 6 weeks and 12 months post-op ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
International Multicenter Prospective Transtar Registry
International Transtar Registry - Stapled Transanal Rectal Resection Performed With Contour Transtar Stapler in the Treatment of Obstructed Defecation Syndrome (ODS)

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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
Constipation
Procedure: Stapled Transanal Rectal Resection with Contour Transtar
Transanal Stapling procedure - Stapled Transanal Rectal Resection
Chronic constipation - ODS
Adult Patients with ODS
Intervention: Procedure: Stapled Transanal Rectal Resection with Contour Transtar

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France
 
NCT00909116
CME-08-001
Yes
Ethicon Endo-Surgery (Europe) GmbH
Ethicon Endo-Surgery (Europe) GmbH
Not Provided
Principal Investigator: Paul-Antoine Lehur, MD,PhD Institut des Maladies de lÀppareil digestif, CHU de nantes, France
Ethicon Endo-Surgery (Europe) GmbH
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP