EnSeal Device Versus Ferguson Technique in Hemorrhoidectomy

The EnSeal Device is approved for laparoscopic 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. This device is being used in the current study in the treatment of hemorrhoidal
disease where vascular tissue is excised in bloodless and sutureless fashion. The device is
FDA-approved for laparoscopic surgery. This is currently being used in institutions
throughout the United States and Europe.

This study is looking at the EnSeal device and comparing it to a gold standard hemorrhoidal
procedure to see if the OR procedure can be simplified and the postoperative course
improved.

The trial is a randomized, controlled, prospective study. Patients will be informed of the
two techniques being studied and will be randomized in the operating room by opening up an
envelope with the procedure to be employed inside. The envelopes will be numbered 1 through
100, with 50 envelopes containing a slip of paper stating that the surgery will be done
using the Ferguson technique and 50 envelopes containing a slip of paper stating the that
the surgery will be done using the EnSeal device. These slips of paper will be placed in the
envelopes and sealed. The envelopes will be mixed up by someone not involved in the study
and then numbered 1 through 100. No one will know which surgical technique will be used on
the patient until the surgeon opens the envelope on the day of surgery.

Patients will be followed postoperatively in the office during week 1, week 4, and week 12.
At this time, they will be assessed for postoperative complications including but not
limited to: bleeding, urinary retention, infection, fecal impaction, hospital re-admission
and pain. Delayed complications will also be followed including urinary retention, impaired
healing, constipation, abscess, fistula formation, fissure, stenosis, fecal incontinence,
and flatus incontinence. The patient's pain score will be assessed using the Universal Pain
Assessment Tool, allowing the patient to describe their pain level on a scale between 1 and
10.