Assessment of a Slotted Anoscope That Facilitates Hemorrhoidectomy

Ethicon Endo-Surgery2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Excisional Hemorrhoidectomy

Interventions

Slotted AnoscopeDEVICE

SA411

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

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

Outcomes

Primary Outcomes

Procedure Duration (Surgery Time)

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.

Time frame: Time of surgery

Data from ClinicalTrials.gov

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