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

This study has been completed.
Information provided by (Responsible Party):
Medtronic - MITG Identifier:
First received: January 28, 2011
Last updated: October 24, 2014
Last verified: October 2014
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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Medtronic - MITG:

Primary Outcome Measures:
  • 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 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 ]

    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 ]
    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 ]
    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 ]
    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 ]
    Length of hospital stay is defined as time of anoscope insertion until discharge

  • Operative Room (OR) Time [ Time Frame: Day 0 ]
    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


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01306877

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

Responsible Party: Medtronic - MITG 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

Keywords provided by Medtronic - MITG:
hemorrhoid stapler

Additional relevant MeSH terms:
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on September 20, 2017