Clinical trial NCT00853853: EnSeal Device Versus Ferguson Technique in Hemorrhoidectomy
Official title: Randomized Trial Comparing Standard Ferguson Technique With the EnSeal Device During Hemorrhoidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhoids
Keywords: Hemorrhoidectomy
Hemorrhoids
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: Ethicon, Inc.
First posted: 2009-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare hemorrhoid surgery by comparing a sutureless heating device with the old standard hemorrhoid surgery. Patients will be followed closely for wound healing and satisfaction.

Hypothesis: The sutureless device will be less painful for the patient and easier for the surgeon to perform.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Men \& woman between ages 18-80.
2. ASA level I, II, and III.
3. External hemorrhoids may or may not be present.
4. Internal hemorrhoids at least Grade II, III, and IV.

Exclusion Criteria:

1. Age less than 18, or greater than 80.
2. ASA level IV.
3. Grade I internal hemorrhoids.
4. Patients on Coumadin, Plavix, or other anticoagulant.
5. Associated procedure such as sphincterotomy, drainage of abscess, fistulotomy, or the like.
6. Pregnancy - Women who have a positive urine pregnancy test pre-op will be excluded from the study.
7. Inflammatory bowel disease.
8. History of chronic active hepatitis B, C, or HIV infection.
9. Lactating women.
10. Inability to follow up with surgeon in office at 1 week, 4 weeks, and 3 months postoperatively.
11. Prior chronic narcotic use (\> 30 days)

Primary outcomes:
measure: to examine the advantage and disadvantages of the EnSeal device as it applies to hemorrhoidal surgery and document outcomes as compared to the traditional closed Ferguson hemorrhoidectomy
timeFrame: 1 week, 4 weeks and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Steven Schechter, MD
role: PRINCIPAL_INVESTIGATOR
References: