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Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
F. Hetzer, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT00673400
First received: May 5, 2008
Last updated: October 1, 2012
Last verified: October 2012
History of Changes

May 5, 2008
October 1, 2012
January 2008
November 2008   (final data collection date for primary outcome measure)
Quality of Life [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]

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)
Quality of life [ Time Frame: before intervention and 6 months after intervention ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00673400 on ClinicalTrials.gov Archive Site
  • Morbidity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205)
  • Hospitalization [ Time Frame: 1 day to 1 year (until release from hospital) ] [ Designated as safety issue: No ]
    Length of hospital stay (Date of release - Date of admission + 1)
  • Morbidity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Hospitalization [ Time Frame: Length of hospital stay ] [ Designated as safety issue: No ]
  • Severity of Symptoms Score [ Time Frame: before surgery - 6 weeks - 3 months - 6 months ] [ Designated as safety issue: No ]

    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)

  • Obstructive Defecation Syndrome Score [ Time Frame: before surgery - 6 weeks -3 months - 6 months ] [ Designated as safety issue: No ]

    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)

  • SF36 Component Summary Scores [ Time Frame: Before surgery - 6 months ] [ Designated as safety issue: No ]

    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.
Not Provided
 
Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM
Morbidity and Functional Outcome of Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM in Obstructed Defecation

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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obstructed Defecation Syndrome
  • Rectocele
  • Intussusception
  • SNS
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.
Stapled transanal rectum resection
patients operated with stapled transanal rectum resection
Intervention: Procedure: Stapled transanal rectum resection
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
November 2009
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Rectocele
  • Intussusception

Exclusion Criteria:

  • Non operability
  • inflammatory bowel disease
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00673400
STARR
No
F. Hetzer, Cantonal Hospital of St. Gallen
Cantonal Hospital of St. Gallen
Not Provided
Principal Investigator: Franc Hetzer, MD Cantonal Hospital St. Gallen, Department of Surgery
Cantonal Hospital of St. Gallen
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP