Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy

Not Applicable

Terminated

• Conditions: Excisional Hemorrhoidectomy

• Registration Number: NCT01264835
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-17
• Study First Submitted QC: 2010-12-20
• Study First Posted: 2010-12-22
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2011-11-28
• Status Verified: 2012-02
• Results First Submitted QC: 2012-02-01
• Last Update Submitted: 2012-02-01
• Results First Posted: 2012-03-02
• Last Update Posted: 2012-03-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Procedure Duration (Surgery Time)	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.

Trial Locations

Locations (3)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

University of South Alabama; 🇺🇸 Mobile, Alabama, United States

Saint Joseph's Hospital of Atlanta; 🇺🇸 Atlanta, Georgia, United States