Sponsor study identifier
interventional
52
1 country
1
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2008
Actual (reported)Study Completion
November 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
May 5, 2008
Actual (reported)May 7, 2008
Actual (reported)November 2008
Actual (reported)November 2009
Actual (reported)October 2, 2012
Actual (reported)Quality of Life
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
Morbidity
1 year
Hospitalization
1 day to 1 year (until release from hospital)
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Surgery, Cantonal Hospital St. Gallen
Sankt Gallen, 9007, Switzerland
Wolff K, Marti L, Beutner U, Steffen T, Lange J, Hetzer FH. Functional outcome and quality of life after stapled transanal rectal resection for obstructed defecation syndrome. Dis Colon Rectum. 2010 Jun;53(6):881-8. doi: 10.1007/DCR.0b013e3181cdb445.
Franc Hetzer, MD
Cantonal Hospital St. Gallen, Department of Surgery
52 participants (actual enrollment reported by the registry).
First Submitted
May 5, 2008
First Posted
May 7, 2008
Study Start
January 2008
Date type not reportedThis date has not been verified as actual or estimated.
Severity of Symptoms Score
before surgery - 6 weeks - 3 months - 6 months
Obstructive Defecation Syndrome Score
before surgery - 6 weeks -3 months - 6 months
SF36 Component Summary Scores
Before surgery - 6 months
Contact the study team to confirm eligibility.
Primary Completion
November 2008
Actual (reported)Study Completion
November 2009
Actual (reported)Last Updated
October 2, 2012
Results First Posted
October 2, 2012
Record last verified: 2012-10
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Source: ClinicalTrials.gov.
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