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Clinical Trials/NCT01306877
NCT01306877CompletedNot Applicable

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)

Medtronic - MITG1 site in 1 country149 target enrollmentStarted: January 1, 2011Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
149
Locations
1
Primary Endpoint
Intraoperative Bleeding
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

EEA Hemorrhoid and Prolapse Stapling Set

Experimental

Intervention: EEA Hemorrhoid and Prolapse Stapling Set (Device)

Endosurgery Proximate PPH03 Stapling Set

Active Comparator

Intervention: Endosurgery Proximate PPH03 Stapling Set (Device)

Outcomes

Primary Outcomes

Intraoperative Bleeding

Time Frame: Day 0 - time of surgery

Number of subjects who require intervention to stop intraoperative bleeding The analysis is based on the per protocol analysis set. Subjects who were misrandomized for excluded from this analysis therefore, the population here will differ from the participant flow.

Secondary Outcomes

  • Post Operative Pain - (PI-NIRS)(Day 0 minus 60 (baseline), Day 0 (discharge), Day 0 plus 7, Day 0 plus 30, Day 0 plus 90, Day 0 plus 180)
  • Post-Operative Pain (Analgesic Intake)(Day 0, 1 week, 2 week, 1 month, 3 month, 6 month)
  • Overall Quality of Life - General Health Score(Day 0 minus 60, 1 week, 1 month, 3 months, 6 months)
  • Location of the Staple Line(Day 0)
  • Length of Stay(Day 0 time of discharge minus time of admission)
  • Operative Room (OR) Time(Day 0)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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