EnSeal Device Versus Ferguson Technique in Hemorrhoidectomy
NCT ID: NCT00853853
Last Updated: 2012-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2009-03-31
2012-12-31
Brief Summary
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Hypothesis: The sutureless device will be less painful for the patient and easier for the surgeon to perform.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1. EnSeal Device
The EnSeal device cuts and seals with heat energy leaving a sutureless wound, which heals with security against bleeding. The device is able to seal blood vessels up to 7mm and hemorrhoidal vessels are much smaller than this size.
EnSeal Device
Hemorrhoidectomy using the EnSeal Device, which is an instrument cuts and seals with heat energy leaving a sutureless wound, which heals with security against bleeding.
2. Ferguson Hemorrhoidectomy
The closed Ferguson hemorrhoidectomy technique is a gold standard operation that has been in existence for 50 years. This operation is done under general or intravenous sedation, and the operating surgeon uses a special clamp to go across the hemorrhoidal complex followed by excision of the hemorrhoid. Sutures that dissolve are then placed at the root of the hemorrhoid, securely tied, and then run about the clamp. The clamp is removed and then the suture tightened, then the suture line is reinforced.
Ferguson Hemorrhoidectomy technique
The closed Ferguson hemorrhoidectomy technique is a gold standard operation that has been in existence for 50 years. This operation is done under general or intravenous sedation, and the operating surgeon uses a special clamp to go across the hemorrhoidal complex followed by excision of the hemorrhoid. Sutures that dissolve (such as 3.0 vicryl) are then placed at the root of the hemorrhoid, securely tied, and then run about the clamp. The clamp is removed and then the suture tightened, then the suture line is reinforced. This can be done from 1-3 hemorrhoidal groups at a single time.
Interventions
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EnSeal Device
Hemorrhoidectomy using the EnSeal Device, which is an instrument cuts and seals with heat energy leaving a sutureless wound, which heals with security against bleeding.
Ferguson Hemorrhoidectomy technique
The closed Ferguson hemorrhoidectomy technique is a gold standard operation that has been in existence for 50 years. This operation is done under general or intravenous sedation, and the operating surgeon uses a special clamp to go across the hemorrhoidal complex followed by excision of the hemorrhoid. Sutures that dissolve (such as 3.0 vicryl) are then placed at the root of the hemorrhoid, securely tied, and then run about the clamp. The clamp is removed and then the suture tightened, then the suture line is reinforced. This can be done from 1-3 hemorrhoidal groups at a single time.
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
80 Years
ALL
Yes
Sponsors
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Ethicon, Inc.
INDUSTRY
Steven Schechter, M.D.
OTHER
Responsible Party
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Steven Schechter, M.D.
Site Director of Colorectal Fellowship program for The Miriam Hospital affiliated with Brown University Program in Colorectal Surgery
Principal Investigators
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Steven Schechter, MD
Role: PRINCIPAL_INVESTIGATOR
The Miriam Hospital
Locations
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The Miriam Hospital
Providence, Rhode Island, United States
Countries
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Other Identifiers
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2048-08
Identifier Type: -
Identifier Source: org_study_id