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)
Verified date | August 2017 |
Source | Ethicon Endo-Surgery (Europe) GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Andree D`Hoore | Leuven |
Lead Sponsor | Collaborator |
---|---|
Ethicon Endo-Surgery (Europe) GmbH |
Belgium,
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
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 |
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