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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
  Purpose

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.


Condition Intervention
Obstructed Defecation Syndrome
Rectocele
Intussusception
SNS
 Procedure: Stapled transanal rectum resection

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Morbidity and Functional Outcome of Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM in Obstructed Defecation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Other Outcome Measures:
  • 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.



Enrollment: 52
Study Start Date: January 2008
Study Completion Date: November 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Stapled transanal rectum resection
patients operated with stapled transanal rectum resection
 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rectocele
  • Intussusception

Exclusion Criteria:

  • Non operability
  • inflammatory bowel disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673400

Locations
Switzerland
Department of Surgery, Cantonal Hospital St. Gallen
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Investigators
Principal Investigator: Franc Hetzer, MD Cantonal Hospital St. Gallen, Department of Surgery
  More Information

Additional Information:
Department of Surgery, Cantonal Hospital St. Gallen, Switzerland  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: F. Hetzer, Leitender Arzt, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT00673400     History of Changes
Other Study ID Numbers: STARR
Study First Received: May 5, 2008
Results First Received: July 16, 2012
Last Updated: October 1, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Cantonal Hospital of St. Gallen:
Obstructed defecation syndrome
ODS
Rectocele
Intussusception
STARR

Additional relevant MeSH terms:
Intussusception
Rectocele
Intestinal Obstruction
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013