An interventional study of EnSeal Trio Tissue Sealing Device in Hemorrhoids, sponsored by Swedish Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-06-05.
Sponsored by Swedish Medical Center · Not applicable, Interventional, and Treatment
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.
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.
221 studies on the registry are indexed under Hemorrhoids; 64 are open to participants now.
This study's enrollment of 9 is below the median of 97 across 169 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Swedish Medical Center is the lead sponsor of 40 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
EnSeal Trio Tissue Sealing Device
Device: EnSeal Trio Tissue Sealing Device
For surgery in ligating and dividing vascular tissue during abdominal surgery.
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.
Time frame: 3 to 4 weeks
Delayed Post-Operative Complications
Delayed complications (greater than 4 weeks) will be followed including impaired healing, constipation, abscess, fistula formation, fissure, and stenosis.
Time frame: 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.
Time frame: 1 month
This study is terminated, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Swedish Medical Center