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

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.

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)