Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM

Rectocele Clinical Trial

— STARR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673400
• Other study ID #: STARR
• Status: Completed
• Phase: N/A
• First received: May 5, 2008
• Last updated: October 1, 2012
• Start date: January 2008
• Est. completion date: November 2009

Study information

• Verified date: October 2012
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Rectocele

• Intussusception

Exclusion Criteria:

• Non operability

• inflammatory bowel disease

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intussusception
• Obstructed Defecation Syndrome
• Rectocele
• SNS

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Switzerland	Department of Surgery, Cantonal Hospital St. Gallen	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Severity of Symptoms Score	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	No
Other	Obstructive Defecation Syndrome Score	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	No
Other	SF36 Component Summary Scores	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	No
Primary	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	No
Secondary	Morbidity	Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205)	1 year	Yes
Secondary	Hospitalization	Length of hospital stay (Date of release - Date of admission + 1)	1 day to 1 year (until release from hospital)	No

External Links

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