Study Stopped
Terminated due to poor accrual.
Comparison Study of Hemorrhoid Surgery Using the Enseal Device to Standard Hemorrhoid Surgical Techniques
Hemorrhoidectomy Using the Enseal Device: A Comparison to Open Hemorrhoidectomy Techniques
1 other identifier
interventional
9
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 22, 2011
CompletedFirst Posted
Study publicly available on registry
August 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJune 5, 2013
June 1, 2013
1.4 years
August 22, 2011
June 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Delayed Post-Operative Complications
3 months
Post-Operative Pain
1 month
Study Arms (1)
EnSeal Device
EXPERIMENTALEnSeal Trio Tissue Sealing Device
Interventions
For surgery in ligating and dividing vascular tissue during abdominal surgery.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Swedish Medical Center Colon Rectal Clinic
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Billingham, MD
Swedish Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2011
First Posted
August 24, 2011
Study Start
August 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
June 5, 2013
Record last verified: 2013-06