Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy

Ethicon

Status: Terminated

Conditions: Excisional Hemorrhoidectomy

Treatments: Device: Slotted Anoscope

Study type: Interventional

Funder types: Industry

Identifiers

NCT01264835

CI-10-0003

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)