Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy

This study has been terminated.
(Slow Enrollment)
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT01264835
First received: December 17, 2010
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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 Intervention
Excisional Hemorrhoidectomy
Device: Slotted Anoscope

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:
  • Procedure Duration (Surgery Time) [ Time Frame: Time of surgery ] [ Designated as safety issue: No ]
    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.


Enrollment: 2
Study Start Date: December 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Slotted Anoscope
    SA411
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264835

Locations
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
  More Information

No publications provided

Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT01264835     History of Changes
Other Study ID Numbers: CI-10-0003
Study First Received: December 17, 2010
Results First Received: November 28, 2011
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014