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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00810745
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : February 26, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Rectal Prolapse Procedure: starr Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : January 2006
Primary Completion Date : September 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: rectal resection Procedure: starr
stapled transanal rectal resection


Outcome Measures

Primary Outcome Measures :
  1. incidence of recurrences [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. outcomes on symptoms and defecography [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810745


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

Responsible Party: first department of general surgery, university of milan
ClinicalTrials.gov Identifier: NCT00810745     History of Changes
Other Study ID Numbers: starr
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: February 26, 2009
Last Verified: February 2009

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