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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00909116

Enrollment

100

Registered

2009-05-27

Start date

2009-01-31

Completion date

2012-04-30

Last updated

2017-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Keywords

ODS, chronic constipation, internal rectal prolapse, rectocele, Stapled Transanal Rectal Resection, Contour Transtar, STARR

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.

Interventions

PROCEDUREStapled Transanal Rectal Resection with Contour Transtar

Transanal Stapling procedure - Stapled Transanal Rectal Resection

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change in constipation symptoms measured by KESS score	preoperative, and at 12 months post-op

Secondary

Measure	Time frame
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026