Long Term Results of STARR With Contour Transtar (LTSTARR)

November 21, 2016 updated by: Francesco Saverio Mari, MD, PhD, FACS, University of Roma La Sapienza

STARR With Contour Transtar for Obstructed Defecation Syndrome: Long Term Results

Obstructed defecation syndrome (ODS) is a widespread and disabling syndrome. With this study the investigators want to evaluate the long term results of Stapled Transanal Rectal Resection (STARR) performed with Contour Transtar device in the treatment of ODS. A re-evaluation of 113 patients subjected to STARR from June 2007 to January 2010 was conducted.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with symptomatic ODS after failure of medical and dietary therapy and with the presence determined through cinedefecography of a rectocele that did not empty and/or a recto-rectal or recto-anal intussusception, in the absence of anal sphincter contractile deficiency

Description

Inclusion Criteria:

  • ODS
  • presence of a rectocele that did not empty and/or a recto-rectal or recto-anal intussusception.

Exclusion Criteria:

  • anal sphincter contractile deficiency
  • previous rectal resection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment Group
Patients candidated to STARR after the failure of medical and dietary therapy and after a complete radiological and functional study.
Procedure: Stapled Transanal Rectal Resection

The prolapsed tissue is pulled out through the CAD using e gauze pad and Allis forceps; this allows us to identify the extent of the prolapse to be resected. Four to five parachute stitches are then apposed circumferentially, like parachute cords, at the apex of the prolapse, in order to control the tissue during resection. The prolapse is then opened longitudinally at 3 o'clock with the electric scalpel between two Kocher clamps. Two traction stitches are applied at the deep vertex of the prolapse, one for each Kocher apex.

The longitudinal opening then allows the surgeon to begin circumferential resection of the rectum by pulling on the parachute stitches. This maneuver is performed counterclockwise using an average of 4-6 recharges, with care to always place the stapler at the base of the prolapse. The resected specimen was always inspected before the end of the procedure.

Other Names:
  • STARR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of constipation
Time Frame: 6 months
Cleveland Clinic Constipation Score
6 months
degree of constipation
Time Frame: 5 years
Cleveland Clinic Constipation Score
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Complications
Time Frame: 0-6 months
intraoperative and postoperative surgical complications
0-6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Defecatory aids
Time Frame: 6 months
the use of laxatives or digitation to defecate
6 months
Defecatory aids
Time Frame: 5 years
the use of laxatives or digitation to defecate
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

November 20, 2016

First Submitted That Met QC Criteria

November 21, 2016

First Posted (Estimate)

November 22, 2016

Study Record Updates

Last Update Posted (Estimate)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 21, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STR016a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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