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

Sponsor

Swedish Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT01422473

Collaborator

(none)

Enrollment

Location

Arm

17.1

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhoids	Device: EnSeal Trio Tissue Sealing Device	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Post-operative complications [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.

Secondary Outcome Measures

Delayed Post-Operative Complications [3 months]
Delayed complications (greater than 4 weeks) will be followed including impaired healing, constipation, abscess, fistula formation, fissure, and stenosis.
Post-Operative Pain [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)