LTSTARR: Long Term Results of STARR With Contour Transtar

University of Roma La Sapienza (Other)
Overall Status
Completed ID

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Stapled Transanal Rectal Resection

Study Design

Study Type:
Actual Enrollment :
113 participants
Observational Model:
Time Perspective:
Official Title:
STARR With Contour Transtar for Obstructed Defecation Syndrome: Long Term Results
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Jan 1, 2010
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm 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:
  • Outcome Measures

    Primary Outcome Measures

    1. degree of constipation [6 months]

      Cleveland Clinic Constipation Score

    2. degree of constipation [5 years]

      Cleveland Clinic Constipation Score

    Secondary Outcome Measures

    1. Surgical Complications [0-6 months]

      intraoperative and postoperative surgical complications

    Other Outcome Measures

    1. Defecatory aids [6 months]

      the use of laxatives or digitation to defecate

    2. Defecatory aids [5 years]

      the use of laxatives or digitation to defecate

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • University of Roma La Sapienza


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Francesco Saverio Mari, MD, PhD, FACS, MD, PhD, FACS, University of Roma La Sapienza Identifier:
    Other Study ID Numbers:
    • STR016a
    First Posted:
    Nov 22, 2016
    Last Update Posted:
    Nov 22, 2016
    Last Verified:
    Nov 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 22, 2016