Clinical Trial: Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Cantonal Hospital of St. Gallen

Current Primary Outcome: 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)


Original Primary Outcome: Quality of Life [ Time Frame: before intervention and 6 months after intervention ]

Current Secondary Outcome:

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


Original Secondary Outcome:

  • Morbidity [ Time Frame: 1 year ]
  • Hospitalization [ Time Frame: Length of hospital stay ]


Information By: Cantonal Hospital of St. Gallen

Dates:
Date Received: May 5, 2008
Date Started: January 2008
Date Completion:
Last Updated: October 1, 2012
Last Verified: October 2012