What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation? - Full Text View

Sponsored by:	University of Milan
Information provided by:	University of Milan
ClinicalTrials.gov Identifier:	NCT00810745

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Bowel Movement Pelvic Support Problems Surgery

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

Keywords provided by University of Milan:

ODS
stapled transanal rectal resection

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

Rectal Diseases
Prolapse
Rectal Prolapse

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

Rectal Diseases
Prolapse
Rectal Prolapse

ClinicalTrials.gov processed this record on September 03, 2009