Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy

February 1, 2012 updated by: Ethicon Endo-Surgery
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36693
        • University of South Alabama
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Saint Joseph's Hospital of Atlanta
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure Duration (Surgery Time)
Time Frame: Time of surgery
Procedure duration was defined as the length of time in minutes from first insertion of the slotted anoscope to final removal of the slotted anoscope.
Time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethicon Endo-Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

December 17, 2010

First Submitted That Met QC Criteria

December 20, 2010

First Posted (ESTIMATE)

December 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 2, 2012

Last Update Submitted That Met QC Criteria

February 1, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • CI-10-0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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