Status:

TERMINATED

Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy

Lead Sponsor:

Ethicon Endo-Surgery

Conditions:

Excisional Hemorrhoidectomy

Eligibility:

All Genders

18+ years

Phase:

NA

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 u...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2011

Estimated Enrollment :

2 Patients enrolled

Trial Details

Trial ID

NCT01264835

Start Date

December 1 2010

End Date

June 1 2011

Last Update

March 2 2012

Active Locations (3)

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Page 1 of 1 (3 locations)

1

University of South Alabama

Mobile, Alabama, United States, 36693

2

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, United States, 30342

3

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106