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

NCT ID: NCT01422473

Last Updated: 2013-06-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-01-31

Brief Summary

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.

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.

Conditions

Hemorrhoids

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EnSeal Device

EnSeal Trio Tissue Sealing Device

Group Type: EXPERIMENTAL

EnSeal Trio Tissue Sealing Device

Intervention Type: DEVICE

For surgery in ligating and dividing vascular tissue during abdominal surgery.

Interventions

EnSeal Trio Tissue Sealing Device

For surgery in ligating and dividing vascular tissue during abdominal surgery.

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swedish Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Billingham, MD

Role: PRINCIPAL_INVESTIGATOR

Swedish Medical Center

Locations

Swedish Medical Center Colon Rectal Clinic

Seattle, Washington, United States

Countries

United States

Other Identifiers

IR 4957

Identifier Type: -

Identifier Source: org_study_id