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Completed

NCT Number: NCT00673400

Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM

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.

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Key information

Conditions

Obstructed Defecation Syndrome Digestive System Diseases Gastrointestinal Diseases Hernia Intestinal Diseases Intestinal Obstruction Intussusception Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectocele SNS

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Cantonal Hospital St. Gallen

Sankt Gallen, 9007, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Rectocele
  • Intussusception

Exclusion criteria

  • Non operability
  • inflammatory bowel disease

Treatment and study plan

Stapled transanal rectum resection

Procedure

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Morbidity

    Time frame: 1 year

    Surgical complications after treatment according to Dindo (Ann Surg (2004) 240:205)

  2. Hospitalization

    Time frame: 1 day to 1 year (until release from hospital)

    Length of hospital stay (Date of release - Date of admission + 1)

Other outcomes

  1. Severity of Symptoms Score

    Time frame: before surgery - 6 weeks - 3 months - 6 months

    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)

  2. Obstructive Defecation Syndrome Score

    Time frame: before surgery - 6 weeks -3 months - 6 months

    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)

  3. SF36 Component Summary Scores

    Time frame: Before surgery - 6 months

    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.

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Official study title

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

Acronym: STARR

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
May 7, 2008
Registry last updated
Oct 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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