International Multicenter Prospective Transtar Registry - Full Text View

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:

MedlinePlus related topics: Bowel Movement Constipation Pelvic Support Problems

U.S. FDA Resources

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

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

Locations

Belgium
Andree D`Hoore
Leuven, Belgium, 3000
France
Paul-Antoine Lehur
Nantes Cedex, France, 1 44093

Sponsors and Collaborators

Ethicon Endo-Surgery (Europe) GmbH

Investigators

Principal Investigator:

Paul-Antoine Lehur, MD,PhD

Institut des Maladies de lÀppareil digestif, CHU de nantes, France

More Information

Publications:

Schwandner O, Stuto A, Jayne D, Lenisa L, Pigot F, Tuech JJ, Scherer R, Nugent K, Corbisier F, Basany EE, Hetzer FH. Decision-making algorithm for the STARR procedure in obstructed defecation syndrome: position statement of the group of STARR Pioneers. Surg Innov. 2008 Jun;15(2):105-9. Epub 2008 Apr 9.

Renzi A, Talento P, Giardiello C, Angelone G, Izzo D, Di Sarno G. Stapled trans-anal rectal resection (STARR) by a new dedicated device for the surgical treatment of obstructed defaecation syndrome caused by rectal intussusception and rectocele: early results of a multicenter prospective study. Int J Colorectal Dis. 2008 Oct;23(10):999-1005. Epub 2008 Jul 25.

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:	September 19, 2012
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 May 21, 2013