Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy

Stopped early · Not applicable

Conditions studied: Excisional Hemorrhoidectomy

In brief

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.

Key facts

Study ID

NCT01264835

Run by

Ethicon Endo-Surgery

People needed

2

Starts

2010-12-01

Expected to finish

2011-06-01

Last updated by the study team

2012-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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