EnSeal Device Versus Ferguson Technique in Hemorrhoidectomy - Full Text View

Purpose

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.

Condition	Intervention
Hemorrhoids	Device: EnSeal Device Procedure: Ferguson Hemorrhoidectomy technique

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized Trial Comparing Standard Ferguson Technique With the EnSeal Device During Hemorrhoidectomy

Resource links provided by NLM:

MedlinePlus related topics: Hemorrhoids

U.S. FDA Resources

Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:

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 [ Time Frame: 1 week, 4 weeks and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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.	Device: 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.
Active Comparator: 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.	Procedure: 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.

Arms

Assigned Interventions

Active Comparator: 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.

Device: 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.

Active Comparator: 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.

Procedure: 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.

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853853

Locations

United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906

Sponsors and Collaborators

Steven Schechter, M.D.

Ethicon, Inc.

Investigators

Principal Investigator:

Steven Schechter, MD

The Miriam Hospital

More Information

No publications provided

Responsible Party:	Steven Schechter, M.D., Site Director of Colorectal Fellowship program for The Miriam Hospital affiliated with Brown University Program in Colorectal Surgery, The Miriam Hospital
ClinicalTrials.gov Identifier:	NCT00853853 History of Changes
Other Study ID Numbers:	2048-08
Study First Received:	February 27, 2009
Last Updated:	November 19, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by The Miriam Hospital:

Hemorrhoidectomy
Hemorrhoids

Additional relevant MeSH terms:

Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases

Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013