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OpenTrials
Completed

NCT Number: NCT02971332

Long Term Results of STARR With Contour Transtar

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stapled Transanal Rectal Resection

Procedure

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

Primary outcomes

  1. degree of constipation

    Time frame: 6 months

    Cleveland Clinic Constipation Score

  2. degree of constipation

    Time frame: 5 years

    Cleveland Clinic Constipation Score

Secondary outcomes

  1. Surgical Complications

    Time frame: 0-6 months

    intraoperative and postoperative surgical complications

Other outcomes

  1. Defecatory aids

    Time frame: 6 months

    the use of laxatives or digitation to defecate

  2. Defecatory aids

    Time frame: 5 years

    the use of laxatives or digitation to defecate

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Acronym: LTSTARR

Important dates

Study start
2007
Primary completion
2010
Study completion
2016
First posted
Nov 22, 2016
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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