NCT00909116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2012

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

3.2 years

First QC Date

May 26, 2009

Last Update Submit

August 10, 2017

Conditions

Constipation

Keywords

ODSchronic constipationinternal rectal prolapserectoceleStapled Transanal Rectal ResectionContour TranstarSTARR

Outcome Measures

Primary Outcomes (1)

  • Change in constipation symptoms measured by KESS score

    preoperative, and at 12 months post-op

Secondary Outcomes (1)

  • 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

Study Arms (1)

Chronic constipation - ODS

Adult Patients with ODS

Procedure: Stapled Transanal Rectal Resection with Contour Transtar

Interventions

Stapled Transanal Rectal Resection with Contour TranstarPROCEDURE

Transanal Stapling procedure - Stapled Transanal Rectal Resection

Chronic constipation - ODS

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andree D'Hoore

Leuven, 3000, Belgium

Location

Related Publications (2)

  • 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.

    PMID: 18403378BACKGROUND

  • 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.

    PMID: 18654789BACKGROUND

MeSH Terms

Conditions

ConstipationRectocele

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesHerniaPathological Conditions, Anatomical

Study Officials

  • Goran Ribaric, MD,PhD

    Ethicon Endo-Surgery (Europe) GmbH

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2009

First Posted

May 27, 2009

Study Start

January 31, 2009

Primary Completion

April 30, 2012

Study Completion

April 30, 2012

Last Updated

August 11, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

via publication

Locations

BE(1)