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EnSeal Device Versus Ferguson Technique in Hemorrhoidectomy

NCT00853853 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-11-20

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Ethicon, Inc.

    collaborator INDUSTRY

  • Steven Schechter, M.D.

    lead OTHER

Principal Investigators

  • Steven Schechter, MD · The Miriam Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00853853 on ClinicalTrials.gov