Comparison Study of Hemorrhoid Surgery Using the Enseal Device to Standard Hemorrhoid Surgical Techniques

June 4, 2013 updated by: Swedish Medical Center

Hemorrhoidectomy Using the Enseal Device: A Comparison to Open Hemorrhoidectomy Techniques

The purpose of this study is to examine the advantages and disadvantages of using the EnSeal device in hemorrhoid surgery as compared to traditional hemorrhoid surgery techniques.

It is hypothesized that the use of the Enseal device will demonstrate an improvement a patient's overall experience through less postoperative bleeding and pain, decreased time for wound healing, and a faster return to work.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The EnSeal Device is FDA approved for surgery in ligating and dividing vascular tissue during abdominal surgery. Electrical energy is converted into heat energy and resultant simultaneous division of tissues. This allows surgery to be bloodless and sutureless. It has been successfully used by many individual practitioners for hemorrhoidectomy, with apparent advantage and success; but to date, no comparative study has been done to assess the advantages and disadvantages of this method of hemorrhoidectomy, when compared to traditional excisional techniques. The investigators propose to use this device in the current study in the treatment of hemorrhoidal disease where vascular tissue is excised in bloodless and sutureless fashion. It is currently being used in institutions throughout the United States and Europe.

After surgery, patients will receive the same standard postoperative instructions as for conventional hemorrhoidectomy, which include wound care, pain medicine, and other standard instructions. The patient will be followed in the office with visits at 3 to 4weeks, and 3 months postoperatively.

At these visits, they will be assessed for postoperative complications including but not limited to: bleeding, urinary retention, fecal impaction, hospital re-admission and pain. Delayed complications -greater than four weeks- will be followed including impaired healing, constipation, abscess, fistula formation, fissure, and stenosis. The patient's pain score and type and amount of pain medications taken will be recorded by the patient daily for the first 2 weeks then weekly for a month postoperatively. This will be assessed using a pain diary which includes a visual analog pain scale (allowing the patient to describe their pain level on a scale between 1 and 10) and space to note the quantity of pain medications used. During each office visit, the operating surgeon will evaluate the patient.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center Colon Rectal Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women between ages 18 through 80
  • American Society of Anesthesiologists (ASA) level I, II and III
  • External hemorrhoids must be present and deemed sufficiently symptomatic to warrant removal
  • Internal hemorrhoids at least Grade II
  • Must be able to be seen post-operatively by the surgeon at 3 to 4 weeks and 3 months after surgery

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) level IV
  • Grade I internal hemorrhoids
  • Currently receiving coumadin, plavix, or other anticoagulants
  • No prior sphincterotomy, drainage of abscess, fistulotomy, or similar procedures
  • No pregnant women at the time of surgery
  • No lactating women
  • No inflammatory bowel disease
  • No history of chronic, active hepatitis B, C, or HIV infection
  • No prior chronic narcotic use (more than 30 days)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EnSeal Device
EnSeal Trio Tissue Sealing Device
Device: EnSeal Trio Tissue Sealing Device
For surgery in ligating and dividing vascular tissue during abdominal surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative complications
Time Frame: 3 to 4 weeks
Patients will be assess for postoperative complications including but not limited to: bleeding, urinary retention, fecal impaction, hospital re-admission and pain.
3 to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delayed Post-Operative Complications
Time Frame: 3 months
Delayed complications (greater than 4 weeks) will be followed including impaired healing, constipation, abscess, fistula formation, fissure, and stenosis.
3 months
Post-Operative Pain
Time Frame: 1 month
The patient's pain score and type and amount of pain medications taken will be recorded by the patient daily for the first 2 weeks then weekly for a month postoperatively.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swedish Medical Center

Investigators

  • Principal Investigator: Richard Billingham, MD, Swedish Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

August 22, 2011

First Submitted That Met QC Criteria

August 23, 2011

First Posted (Estimate)

August 24, 2011

Study Record Updates

Last Update Posted (Estimate)

June 5, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR 4957

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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