Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01264835
Recruitment Status : Terminated (Slow Enrollment)
First Posted : December 22, 2010
Results First Posted : March 2, 2012
Last Update Posted : March 2, 2012
Information provided by (Responsible Party):
Ethicon Endo-Surgery

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Excisional Hemorrhoidectomy Device: Slotted Anoscope Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Intervention Details:
  • Device: Slotted Anoscope

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01264835

United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36693
United States, Georgia
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Ethicon Endo-Surgery

Responsible Party: Ethicon Endo-Surgery Identifier: NCT01264835     History of Changes
Other Study ID Numbers: CI-10-0003
First Posted: December 22, 2010    Key Record Dates
Results First Posted: March 2, 2012
Last Update Posted: March 2, 2012
Last Verified: February 2012