HemorrhoidsNCT00853853
EnSeal Device Versus Ferguson Technique in Hemorrhoidectomy
A study testing EnSeal Device and Ferguson Hemorrhoidectomy technique in people with Hemorrhoids, run by Steven Schechter, M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- EnSeal Device and Ferguson Hemorrhoidectomy technique
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial Comparing Standard Ferguson Technique With the EnSeal Device During Hemorrhoidectomy
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.
Read the 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.
- Conditions
- Hemorrhoids
- Being tested
- EnSeal Device, Ferguson Hemorrhoidectomy technique
- Keywords
- Hemorrhoidectomy, Hemorrhoids
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnSeal DeviceDevice
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 techniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1. EnSeal Device | Active comparator | 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. Receives: Device: EnSeal Device |
| 2. Ferguson Hemorrhoidectomy | Active comparator | 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. Receives: Procedure: Ferguson Hemorrhoidectomy technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week, 4 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steven Schechter, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon, Inc.
- Responsible party
- Sponsor-investigator, Steven Schechter, M.D., The Miriam Hospital
- Investigators
- Steven Schechter, MD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00853853
- Sponsor's protocol ID
- 2048-08
- Status last verified
- Nov 2012
- First submitted
- 27 Feb 2009
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Standard Ferguson Technique With the EnSeal Device During Hemorrhoidectomy
- ClinicalTrials.gov ID
- NCT00853853
- Acronym / sponsor ID
- 2048-08
- Conditions
- Hemorrhoids
- Keywords
- Hemorrhoidectomy, Hemorrhoids
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Steven Schechter, M.D.University, hospital or other
- Collaborators
- Ethicon, Inc.
- Study start
- Mar 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 2 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. EnSeal Device | Active comparator | Device: EnSeal DeviceThe 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. |
| 2. Ferguson Hemorrhoidectomy | Active comparator | Procedure: Ferguson Hemorrhoidectomy techniqueThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnSeal DeviceHemorrhoidectomy using the EnSeal Device, which is an instrument cuts and seals with heat energy leaving a sutureless wound, which heals with security against bleeding. | Device | 1. EnSeal Device |
| Ferguson Hemorrhoidectomy techniqueThe 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. | Procedure or surgery | 2. Ferguson Hemorrhoidectomy |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Schechter, MD principal investigator
The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EnSeal Device and Ferguson Hemorrhoidectomy technique in people with Hemorrhoids, run by Steven Schechter, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 1 week, 4 weeks and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.