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Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids (HEMOSTASIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01306877
First received: January 28, 2011
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Hemorrhoids
Device: EEA Hemorrhoid and Prolapse Stapling Set
Device: Endosurgery Proximate PPH03 Stapling Set

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Intraoperative Bleeding [ Time Frame: Day 0 - time of surgery ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Post Operative Pain - (PI-NIRS) [ Time Frame: Day 0 minus 60 (baseline), Day 0 (discharge), Day 0 plus 7, Day 0 plus 30, Day 0 plus 90, Day 0 plus 180 ] [ Designated as safety issue: No ]

    Post-operative pain as change from baseline pain score as measured by an 11-point Pain Intensity Numeric Rating Scale (PI-NRS). The range of the scale is 0-10 with 0 representing no pain and 10 representing the worst possible pain.

    The data represented is the change in baseline score at the different timepoints.


  • Post-Operative Pain (Analgesic Intake) [ Time Frame: Day 0, 1 week, 2 week, 1 month, 3 month, 6 month ] [ Designated as safety issue: No ]
    post operative pain measured in pos-surgical consumption of strong opioids by the number of participants in the study. Participants are included if they consumed analgesics or strong opiod at anytime during the study.

  • Overall Quality of Life - General Health Score [ Time Frame: Day 0 minus 60, 1 week, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
    Quality of life was measured by SF-12 questionnaire in change from baseline; the socring range is 0 - 100 with 0 = poor overall health and 100 = excellent overall health

  • Location of the Staple Line [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Distance of staple line to dentate line as measure by surgical ruler

  • Length of Stay [ Time Frame: Day 0 time of discharge minus time of admission ] [ Designated as safety issue: No ]
    Length of hospital stay is defined as time of anoscope insertion until discharge

  • Operative Room (OR) Time [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Time of insertion of anoscope to time of anoscope removal after stapleline evaluation


Enrollment: 149
Study Start Date: January 2011
Study Completion Date: January 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EEA Hemorrhoid and Prolapse Stapling Set Device: EEA Hemorrhoid and Prolapse Stapling Set
Surgical device
Active Comparator: Endosurgery Proximate PPH03 Stapling Set Device: Endosurgery Proximate PPH03 Stapling Set
Surgical device

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306877

Locations
United States, Florida
USF Tampa General Hospital Dept of Surgery
Tampa, Florida, United States, 33606
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Jorge Marcet, MD University of South Florida
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01306877     History of Changes
Other Study ID Numbers: COVHEPH0109
Study First Received: January 28, 2011
Results First Received: February 20, 2014
Last Updated: October 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Covidien:
hemorrhoid
hemorrhoid stapler

Additional relevant MeSH terms:
Hemorrhoids
Cardiovascular Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014