Clinical trial NCT01306877: Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids
Official title: Prospective Single Blinded Randomized Controlled Trial Comparing The Covidien EEA™ Hemorrhoid and Prolapse Stapling Set With DST Series™ Technology Vs. Ethicon PPH03 In A Hemorrhoidopexy Procedure (HEMOSTASIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoids
Keywords: hemorrhoid
hemorrhoid stapler
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2011-03-02
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.


Eligibility criteria: Inclusion Criteria:

* The subject is able to understand and sign Informed Consent Form
* The subject is between 18-85 years of age.
* The subject has (symptomatic) Grade 2-3 Hemorrhoids and is eligible for stapled hemorrhoidopexy

Exclusion Criteria:

* The procedure is needed as revision hemorrhoid surgery.
* Any female patient, who is pregnant, suspected pregnant, or nursing.
* The participant has an active or a history of infection requiring antibiotics at the intended operative site within thirty (30) days prior to the planned surgery date.
* The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
* The participant has a 1 year history of drug or alcohol abuse.
* The participant has a history of venous thrombosis or pulmonary embolism.
* The participant has a history of coagulopathy.
* The participant has taken aspirin, anti-coagulation and/or anti platelet therapies (e.g. Warfarin, Lovenox) within 7 days prior to the planned date of surgery.
* The participant has a history of fecal incontinence
* The participant has had injection therapy, infrared laser treatment or rubber band ligation for treatment of hemorrhoids within 1 month of screening
* The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.

Primary outcomes:
measure: Intraoperative Bleeding
timeFrame: Day 0 - time of surgery
Secondary outcomes:
measure: Post Operative Pain - (PI-NIRS)
timeFrame: Day 0 minus 60 (baseline), Day 0 (discharge), Day 0 plus 7, Day 0 plus 30, Day 0 plus 90, Day 0 plus 180
measure: Post-Operative Pain (Analgesic Intake)
timeFrame: Day 0, 1 week, 2 week, 1 month, 3 month, 6 month
measure: Overall Quality of Life - General Health Score
timeFrame: Day 0 minus 60, 1 week, 1 month, 3 months, 6 months
measure: Location of the Staple Line
timeFrame: Day 0
measure: Length of Stay
timeFrame: Day 0 time of discharge minus time of admission
measure: Operative Room (OR) Time
timeFrame: Day 0
Other outcomes:
Locations:
city: Tampa
country: United States
facility: USF Tampa General Hospital Dept of Surgery
state: Florida
Study officials:
affiliation: University of South Florida
name: Jorge Marcet, MD
role: PRINCIPAL_INVESTIGATOR
References: