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What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation?

This study has been completed.
Sponsor:
Information provided by:
University of Milan
ClinicalTrials.gov Identifier:
NCT00810745
First received: December 17, 2008
Last updated: February 25, 2009
Last verified: February 2009
History of Changes
  Purpose

This randomized study was designed to compare the 2 year clinical and functional results with the STARR procedure using a new curved cutter stapler or the same operation done with 2 traditional circular staplers.


Condition Intervention Phase
Rectal Prolapse
 Procedure: starr
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation? Two-Year Outcomes From a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Milan:

Primary Outcome Measures:
  • incidence of recurrences [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • outcomes on symptoms and defecography [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: January 2006
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rectal resection Procedure: starr
stapled transanal rectal resection

Detailed Description:

From January to November 2006, 80 women were selected, with clinical examination, constipation score, colonoscopy, anorectal manometry, and perineography and randomly assigned to 2 groups: 40 patients underwent stapled transanal rectal resection with two staplers PPH-01 (Ethicon Endosurgery Inc, Pomezia, Italy) (STARR group) and 40 had the same operation with new, curved multi-fire stapler Contour R Transtar TM (TRANSTAR group). Patients were followed up with clinical examination, constipation score, and perineography.

  Eligibility

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rectal prolapse
  • Rectocele
  • ODS score > 15
  • Continence score < 3
  • Resting pressure > 40 mm/Hg

Exclusion Criteria:

  • Previous anorectal surgery
  • Ods score < 15
  • Continence score > 3
  • Resting pressure < 40
  • Concomitant pelvic floor diseases
  • Psychiatric diseases
  • Absolute contraindications to surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810745

Locations
Italy
First Department of General Surgery
Milan, Italy, 20122
First department of general surgery university of milan
Milan, Italy, 20122
Sponsors and Collaborators
University of Milan
Investigators
Principal Investigator: paolo boccasanta, md 1 department of general surgery
  More Information

No publications provided

Responsible Party: first department of general surgery, university of milan
ClinicalTrials.gov Identifier: NCT00810745     History of Changes
Other Study ID Numbers: starr
Study First Received: December 17, 2008
Last Updated: February 25, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by University of Milan:
ODS
stapled transanal rectal resection

Additional relevant MeSH terms:
Prolapse
Rectal Prolapse
Pathological Conditions, Anatomical
Rectal Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pelvic Organ Prolapse

ClinicalTrials.gov processed this record on May 19, 2013