Comparison Study of Hemorrhoid Surgery Using the Enseal Device to Standard Hemorrhoid Surgical Techniques

Hemorrhoids Clinical Trial

Official title:

Hemorrhoidectomy Using the Enseal Device: A Comparison to Open Hemorrhoidectomy Techniques

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01422473
• Other study ID #: IR 4957
• Status: Terminated
• Phase: N/A
• First received: August 22, 2011
• Last updated: June 4, 2013
• Start date: August 2011
• Est. completion date: January 2013

Study information

• Verified date: June 2013
• Source: Swedish Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• No inflammatory bowel disease

• No history of chronic, active hepatitis B, C, or HIV infection

• No prior chronic narcotic use (more than 30 days)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

Device:
• EnSeal Trio Tissue Sealing Device
For surgery in ligating and dividing vascular tissue during abdominal surgery.

Locations

Country	Name	City	State
United States	Swedish Medical Center Colon Rectal Clinic	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 to 4 weeks	No
Secondary	Delayed Post-Operative Complications	Delayed complications (greater than 4 weeks) will be followed including impaired healing, constipation, abscess, fistula formation, fissure, and stenosis.	3 months	No
Secondary	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.	1 month	No