Clinical trial NCT00909116: International Multicenter Prospective Transtar Registry
Official title: International Transtar Registry - Stapled Transanal Rectal Resection Performed With Contour Transtar Stapler in the Treatment of Obstructed Defecation Syndrome (ODS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Constipation
Keywords: ODS
chronic constipation
internal rectal prolapse
rectocele
Stapled Transanal Rectal Resection
Contour Transtar
STARR
Lead sponsor: Ethicon Endo-Surgery (Europe) GmbH
Sponsor class: INDUSTRY
First posted: 2009-05-27
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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 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.

Primary outcomes:
measure: Change in constipation symptoms measured by KESS score
timeFrame: preoperative, and at 12 months post-op
Secondary outcomes:
measure: Changes in patients symptoms measured by Incontinence score and ODS Score, QoL measures with EQ5D and PAC-QoL
timeFrame: preoperative, at 6 weeks and 12 months post-op
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Andree D'Hoore
Study officials:
affiliation: Ethicon Endo-Surgery (Europe) GmbH
name: Goran Ribaric, MD,PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.