What Benefit With a New Stapler Device in the Surgical Tr... | NCT00810745

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

NCT00810745

Sponsor

University of Milan

Status

Completed

Last Update Posted

Feb 26, 2009Estimated

Enrollment

80Actual

Phase

Phase 4

Conditions

Rectal Prolapse

Interventions

starr

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Sep 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Dec 17, 2008

First Submission Date that Met QC Criteria

Dec 17, 2008

First Posted Date

Dec 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2009

Last Update Posted Date

Feb 26, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rectal resection	Experimental		Procedure: starr

Interventions

Name	Type	Description	Arm Group Labels	Other Names
starr	Procedure	stapled transanal rectal resection	rectal resection

Measure	Description	Time Frame
incidence of recurrences		2 years

Measure	Description	Time Frame
outcomes on symptoms and defecography		2 years

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
paolo boccasanta, md	1 department of general surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First department of general surgery university of milan		Milan		20122	Italy
First Department of General Surgery

Type	Date	Date Unknown
Release	Nov 16, 2009
Reset	Dec 16, 2009
Release	Dec 18, 2009
Reset	Jan 22, 2010

Submission Tracking

Estimated Results First Submitted Date

Nov 16, 2009

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 16, 2009			Dec 16, 2009
Dec 18, 2009

Condition Browse Module

MeSH Terms

ID	Term
D012005	Rectal Prolapse

Ancestor Terms

ID	Term
D012002	Rectal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided