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

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

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:

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.


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

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

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
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:
stapled transanal rectal resection

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

ClinicalTrials.gov processed this record on April 23, 2014