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

This study has been terminated.
(Terminated due to poor accrual.)
Sponsor:
Information provided by (Responsible Party):
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT01422473
First received: August 22, 2011
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Hemorrhoids
Device: EnSeal Trio Tissue Sealing Device

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hemorrhoidectomy Using the Enseal Device: A Comparison to Open Hemorrhoidectomy Techniques

Resource links provided by NLM:


Further study details as provided by Swedish Medical Center:

Primary Outcome Measures:
  • Post-operative complications [ Time Frame: 3 to 4 weeks ] [ Designated as safety issue: No ]
    Patients will be assess for postoperative complications including but not limited to: bleeding, urinary retention, fecal impaction, hospital re-admission and pain.


Secondary Outcome Measures:
  • Delayed Post-Operative Complications [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Delayed complications (greater than 4 weeks) will be followed including impaired healing, constipation, abscess, fistula formation, fissure, and stenosis.

  • Post-Operative Pain [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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.


Enrollment: 9
Study Start Date: August 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422473

Locations
United States, Washington
Swedish Medical Center Colon Rectal Clinic
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Swedish Medical Center
Investigators
Principal Investigator: Richard Billingham, MD Swedish Medical Center
  More Information

No publications provided

Responsible Party: Swedish Medical Center
ClinicalTrials.gov Identifier: NCT01422473     History of Changes
Other Study ID Numbers: IR 4957
Study First Received: August 22, 2011
Last Updated: June 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Swedish Medical Center:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014