International Multicenter Prospective Transtar Registry

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909116
• Other study ID #: CME-08-001
• Status: Completed
• Phase: N/A
• First received: May 26, 2009
• Last updated: August 10, 2017
• Start date: January 31, 2009
• Est. completion date: April 30, 2012

Study information

• Verified date: August 2017
• Source: Ethicon Endo-Surgery (Europe) GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 30, 2012
• Est. primary completion date: April 30, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constipation

Intervention

Procedure:
• Stapled Transanal Rectal Resection with Contour Transtar
Transanal Stapling procedure - Stapled Transanal Rectal Resection

Locations

Country	Name	City	State
Belgium	Andree D`Hoore	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery (Europe) GmbH

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. doi: 10.1007/s00384-008-0522-0. Epub 2008 Jul 25. — View Citation

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. doi: 10.1177/1553350608316684. Epub 2008 Apr 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in constipation symptoms measured by KESS score		preoperative, and at 12 months post-op
Secondary	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