Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-01-31

Brief Summary

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The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.

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Detailed Description

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Conditions

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Hemorrhoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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EEA Hemorrhoid and Prolapse Stapling Set

Group Type EXPERIMENTAL

EEA Hemorrhoid and Prolapse Stapling Set

Intervention Type DEVICE

Surgical device

Endosurgery Proximate PPH03 Stapling Set

Group Type ACTIVE_COMPARATOR

Endosurgery Proximate PPH03 Stapling Set

Intervention Type DEVICE

Surgical device

Interventions

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EEA Hemorrhoid and Prolapse Stapling Set

Surgical device

Intervention Type DEVICE

Endosurgery Proximate PPH03 Stapling Set

Surgical device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The subject is able to understand and sign Informed Consent Form
* The subject is between 18-85 years of age.
* The subject has (symptomatic) Grade 2-3 Hemorrhoids and is eligible for stapled hemorrhoidopexy

Exclusion Criteria

* The procedure is needed as revision hemorrhoid surgery.
* Any female patient, who is pregnant, suspected pregnant, or nursing.
* The participant has an active or a history of infection requiring antibiotics at the intended operative site within thirty (30) days prior to the planned surgery date.
* The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
* The participant has a 1 year history of drug or alcohol abuse.
* The participant has a history of venous thrombosis or pulmonary embolism.
* The participant has a history of coagulopathy.
* The participant has taken aspirin, anti-coagulation and/or anti platelet therapies (e.g. Warfarin, Lovenox) within 7 days prior to the planned date of surgery.
* The participant has a history of fecal incontinence
* The participant has had injection therapy, infrared laser treatment or rubber band ligation for treatment of hemorrhoids within 1 month of screening
* The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No