Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM (STARR)

October 1, 2012 updated by: F. Hetzer, Cantonal Hospital of St. Gallen

Morbidity and Functional Outcome of Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM in Obstructed Defecation

The stapled transanal rectal resection (STARR procedure) is an effective treatment for obstructed defecation syndrome (ODS) caused by intussusception and rectocele. Recently a new technique has been developed using the new Contour® TranstarTM stapler, which was specifically designed to facilitate the STARR procedure. The investigators would like to evaluate the morbidity and quality of life.

Study Overview

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • St. Gallen, Switzerland, 9007
        • Department of Surgery, Cantonal Hospital St. Gallen

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Rectocele
  • Intussusception

Exclusion Criteria:

  • Non operability
  • inflammatory bowel disease

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Stapled transanal rectum resection
patients operated with stapled transanal rectum resection
Contour Transtar-STR5G (Ethicon EndoSurgery Inc., Cincinnati, OH).The circular anal dilator is fixed to perianal skin.Rectal intussusception is evidenced with a swab.The first stitch is placed superficial on top of the intussusception. The procedure is performed 5to6 times counterclockwise.A final stitch for first radial cut at 3 o'clock.The device is introduced into the rectum. This cut opens the prolapse. Check with a finger the vagina. The device is then closed and fired. After replacing the cartridge, the device is introduced in the rectum, placed parallel to the circular anal dilator and moved counter clockwise with 4to6firings to complete the resection. Additional stitches across the staple line to assure haemostasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 6 months after intervention

Quality of life is measured by Fecal incontinence quality of life (FIQL)

Possible range of score 0 - 4 (Depression/Self perception 4.4)

0 = worst condition

  • Fecal Incontinence Quality of Life (FIQL) (Rockwood, Dis Colon Rectum (2000) 43:9)
6 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: 1 year
Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205)
1 year
Hospitalization
Time Frame: 1 day to 1 year (until release from hospital)
Length of hospital stay (Date of release - Date of admission + 1)
1 day to 1 year (until release from hospital)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of Symptoms Score
Time Frame: before surgery - 6 weeks - 3 months - 6 months

Score based on the severity of 9 symptoms of bowel movement (physician administered)

(0 - 36, no symptoms = 0)

Dis Colon Rectum 39:681 (DOI: 10.1007/BF02056950)

before surgery - 6 weeks - 3 months - 6 months
Obstructive Defecation Syndrome Score
Time Frame: before surgery - 6 weeks -3 months - 6 months

Score based on severity or frequency of 9 symptoms of obstructive defecation (physician administered)

(0 - 40, no symptoms = 0)

Dis Colon Rectum 51:348(DOI: 10.1007/s10350-007-9115-1)

before surgery - 6 weeks -3 months - 6 months
SF36 Component Summary Scores
Time Frame: Before surgery - 6 months

Quality of life short form 36 version 2(SF36v2) standard form

PCS: physical component summary score (range 1 to 81, with 81 being the best) MCS: mental component summary score (range -9 to 82, with 82 being the best)

A score of 50 correlates with the result of a healthy standard US population (score transformation to a mean of 50 and a standard deviation of 10)

Ware JE, Kosinski M, Dewey JE. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: QualityMetric Incorporated, 2000.

Before surgery - 6 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Franc Hetzer, MD, Cantonal Hospital St. Gallen, Department of Surgery

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.

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

January 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

May 5, 2008

First Submitted That Met QC Criteria

May 6, 2008

First Posted (Estimate)

May 7, 2008

Study Record Updates

Last Update Posted (Estimate)

October 2, 2012

Last Update Submitted That Met QC Criteria

October 1, 2012

Last Verified

October 1, 2012

More Information

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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