Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy

NCT ID: NCT01264835

Last Updated: 2012-03-02

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-06-30

Brief Summary

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This trial is designed to assess intra-operative procedure outcomes (e.g.,procedure duration) and post-operative patient outcomes (e.g., pain)following a modified Ferguson hemorrhoidectomy procedure using the Slotted Anoscope with Harmonic or monopolar energy.

Detailed Description

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Conditions

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Excisional Hemorrhoidectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Slotted Anoscope

SA411

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Are at least 18 years of age
* Are willing to give consent and comply with evaluation and treatment schedule
* Meet institutional criteria for excisional hemorrhoidectomy
* Are able to understand and complete study questionnaires.

Exclusion Criteria

* Previous Hemorrhoid surgery
* Chronic daily narcotic use
* Chronic Nonsteroidal Anti-inflammatory Drug use two weeks prior to procedure
* Internal hemorrhoids that may be suitable for office management (surgeon discretion)
* Fecal or urinary incontinence
* Inflammatory Bowel Disease (Crohns, ulcerative colitis)
* Acutely thrombosed hemorrhoids (surgeon discretion)
* Evidence of acute sepsis or the presence of a fistula
* Anal stricture.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ethicon Endo-Surgery

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of South Alabama

Mobile, Alabama, United States

Site Status

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, United States

Site Status

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CI-10-0003

Identifier Type: -

Identifier Source: org_study_id

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