HemorrhoidsNCT01422473
Comparison Study of Hemorrhoid Surgery Using the Enseal Device to Standard Hemorrhoid Surgical Techniques
A study testing EnSeal Trio Tissue Sealing Device in people with Hemorrhoids, run by Swedish Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the advantages and disadvantages of using the EnSeal device in hemorrhoid surgery as compared to traditional hemorrhoid surgery techniques. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemorrhoids
- What is being tested?
- EnSeal Trio Tissue Sealing Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jan 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between ages 18 through 80
- American Society of Anesthesiologists (ASA) level I, II and III
- External hemorrhoids must be present and deemed sufficiently symptomatic to warrant removal
- Internal hemorrhoids at least Grade II
- Must be able to be seen post-operatively by the surgeon at 3 to 4 weeks and 3 months after surgery
Who cannot join
- American Society of Anesthesiologists (ASA) level IV
- Grade I internal hemorrhoids
- Currently receiving coumadin, plavix, or other anticoagulants
- No prior sphincterotomy, drainage of abscess, fistulotomy, or similar procedures
- No pregnant women at the time of surgery
- No lactating women
Show all 9Show fewer
- No inflammatory bowel disease
- No history of chronic, active hepatitis B, C, or HIV infection
- No prior chronic narcotic use (more than 30 days)
Trial locations and contacts
1 site in 1 country.
United States1 site
Swedish Medical Center Colon Rectal Clinic
Seattle, Washington, 98104
About this study
Official title: Hemorrhoidectomy Using the Enseal Device: A Comparison to Open Hemorrhoidectomy Techniques
The purpose of this study is to examine the advantages and disadvantages of using the EnSeal device in hemorrhoid surgery as compared to traditional hemorrhoid surgery techniques.
It is hypothesized that the use of the Enseal device will demonstrate an improvement a patient's overall experience through less postoperative bleeding and pain, decreased time for wound healing, and a faster return to work.
Read the detailed description
The EnSeal Device is FDA approved for 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. It has been successfully used by many individual practitioners for hemorrhoidectomy, with apparent advantage and success; but to date, no comparative study has been done to assess the advantages and disadvantages of this method of hemorrhoidectomy, when compared to traditional excisional techniques. The investigators propose to use this device in the current study in the treatment of hemorrhoidal disease where vascular tissue is excised in bloodless and sutureless fashion. It is currently being used in institutions throughout the United States and Europe.
After surgery, patients will receive the same standard postoperative instructions as for conventional hemorrhoidectomy, which include wound care, pain medicine, and other standard instructions. The patient will be followed in the office with visits at 3 to 4weeks, and 3 months postoperatively.
At these visits, they will be assessed for postoperative complications including but not limited to: bleeding, urinary retention, fecal impaction, hospital re-admission and pain. Delayed complications -greater than four weeks- will be followed including impaired healing, constipation, abscess, fistula formation, fissure, and stenosis. The patient's pain score and type and amount of pain medications taken will be recorded by the patient daily for the first 2 weeks then weekly for a month postoperatively. This will be assessed using a pain diary which includes a visual analog pain scale (allowing the patient to describe their pain level on a scale between 1 and 10) and space to note the quantity of pain medications used. During each office visit, the operating surgeon will evaluate the patient.
- Conditions
- Hemorrhoids
- Being tested
- EnSeal Trio Tissue Sealing Device
- Keywords
- Hemorrhoids, Rectal Diseases, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases
- Medical subject headings
- Hemorrhoids, Rectal Diseases, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnSeal Trio Tissue Sealing DeviceDevice
For surgery in ligating and dividing vascular tissue during abdominal surgery.
| Study group | Role | What they receive |
|---|---|---|
| EnSeal Device | Experimental | EnSeal Trio Tissue Sealing Device Receives: Device: EnSeal Trio Tissue Sealing Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative complications
Patients will be assess for postoperative complications including but not limited to: bleeding, urinary retention, fecal impaction, hospital re-admission and pain.
Measured: 3 to 4 weeks
Secondary outcomes (2)
Delayed Post-Operative Complications
Delayed complications (greater than 4 weeks) will be followed including impaired healing, constipation, abscess, fistula formation, fissure, and stenosis.
Measured: 3 months
Post-Operative Pain
The patient's pain score and type and amount of pain medications taken will be recorded by the patient daily for the first 2 weeks then weekly for a month postoperatively.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Terminated due to poor accrual.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Billingham, MD, Principal investigator, Swedish Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422473
- Sponsor's protocol ID
- IR 4957
- Status last verified
- Jun 2013
- First submitted
- 22 Aug 2011
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemorrhoidectomy Using the Enseal Device: A Comparison to Open Hemorrhoidectomy Techniques
- ClinicalTrials.gov ID
- NCT01422473
- Acronym / sponsor ID
- IR 4957
- Conditions
- Hemorrhoids
- Keywords
- Hemorrhoids, Rectal Diseases, Intestinal Diseases, Gastrointestinal Diseases, Digestive System Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to poor accrual.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 24 Aug 2011 (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.
The purpose of this study is to examine the advantages and disadvantages of using the EnSeal device in hemorrhoid surgery as compared to traditional hemorrhoid surgery techniques.
It is hypothesized that the use of the Enseal device will demonstrate an improvement a patient's overall experience through less postoperative bleeding and pain, decreased time for wound healing, and a faster return to work.
Detailed description
The EnSeal Device is FDA approved for 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. It has been successfully used by many individual practitioners for hemorrhoidectomy, with apparent advantage and success; but to date, no comparative study has been done to assess the advantages and disadvantages of this method of hemorrhoidectomy, when compared to traditional excisional techniques. The investigators propose to use this device in the current study in the treatment of hemorrhoidal disease where vascular tissue is excised in bloodless and sutureless fashion. It is currently being used in institutions throughout the United States and Europe.
After surgery, patients will receive the same standard postoperative instructions as for conventional hemorrhoidectomy, which include wound care, pain medicine, and other standard instructions. The patient will be followed in the office with visits at 3 to 4weeks, and 3 months postoperatively.
At these visits, they will be assessed for postoperative complications including but not limited to: bleeding, urinary retention, fecal impaction, hospital re-admission and pain. Delayed complications -greater than four weeks- will be followed including impaired healing, constipation, abscess, fistula formation, fissure, and stenosis. The patient's pain score and type and amount of pain medications taken will be recorded by the patient daily for the first 2 weeks then weekly for a month postoperatively. This will be assessed using a pain diary which includes a visual analog pain scale (allowing the patient to describe their pain level on a scale between 1 and 10) and space to note the quantity of pain medications used. During each office visit, the operating surgeon will evaluate the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EnSeal Device | Experimental | Device: EnSeal Trio Tissue Sealing DeviceEnSeal Trio Tissue Sealing Device |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women between ages 18 through 80
- American Society of Anesthesiologists (ASA) level I, II and III
- External hemorrhoids must be present and deemed sufficiently symptomatic to warrant removal
- Internal hemorrhoids at least Grade II
- Must be able to be seen post-operatively by the surgeon at 3 to 4 weeks and 3 months after surgery
Key exclusion criteria (9 listed)
- American Society of Anesthesiologists (ASA) level IV
- Grade I internal hemorrhoids
- Currently receiving coumadin, plavix, or other anticoagulants
- No prior sphincterotomy, drainage of abscess, fistulotomy, or similar procedures
- No pregnant women at the time of surgery
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 Trio Tissue Sealing DeviceFor surgery in ligating and dividing vascular tissue during abdominal surgery. | Device | EnSeal Device |
Primary outcome
Post-operative complications
Time frame: 3 to 4 weeks
Patients will be assess for postoperative complications including but not limited to: bleeding, urinary retention, fecal impaction, hospital re-admission and pain.
2 secondary outcomes
Delayed Post-Operative Complications
Time frame: 3 months
Post-Operative Pain
Time frame: 1 month
Results and safety
The study was stopped early (reason given: Terminated due to poor accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
Related trials for Hemorrhoids
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Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain
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Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
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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.
Richard Billingham, MD principal investigator
Swedish Medical Center
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 Trio Tissue Sealing Device in people with Hemorrhoids, run by Swedish Medical Center 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 5 Jun 2013. 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?
The study was stopped early (reason given: Terminated due to poor accrual.). 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?
Post-operative complications (time frame: 3 to 4 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 5 Jun 2013.