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

Primary Purpose

Rectal Prolapse

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
starr
Sponsored by
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Prolapse focused on measuring ODS, stapled transanal rectal resection

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • First department of general surgery university of milan
  • First Department of General Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rectal resection

Arm Description

Outcomes

Primary Outcome Measures

incidence of recurrences

Secondary Outcome Measures

outcomes on symptoms and defecography

Full Information

First Posted
December 17, 2008
Last Updated
February 25, 2009
Sponsor
University of Milan
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1. Study Identification

Unique Protocol Identification Number
NCT00810745
Brief Title
What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation?
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 Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Milan

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Prolapse
Keywords
ODS, stapled transanal rectal resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rectal resection
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
starr
Intervention Description
stapled transanal rectal resection
Primary Outcome Measure Information:
Title
incidence of recurrences
Time Frame
2 years
Secondary Outcome Measure Information:
Title
outcomes on symptoms and defecography
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
paolo boccasanta, md
Organizational Affiliation
1 department of general surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
First department of general surgery university of milan
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
First Department of General Surgery
City
Milan
ZIP/Postal Code
20122
Country
Italy

12. IPD Sharing Statement

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

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