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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01306877
Recruitment Status : Completed
First Posted : March 2, 2011
Results First Posted : October 29, 2014
Last Update Posted : October 29, 2014
Information provided by (Responsible Party):
Medtronic - MITG

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.

Condition or disease Intervention/treatment Phase
Hemorrhoids Device: EEA Hemorrhoid and Prolapse Stapling Set Device: Endosurgery Proximate PPH03 Stapling Set Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
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)
Study Start Date : January 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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

  4. Location of the Staple Line [ Time Frame: Day 0 ]
    Distance of staple line to dentate line as measure by surgical ruler

  5. 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

  6. Operative Room (OR) Time [ Time Frame: Day 0 ]
    Time of insertion of anoscope to time of anoscope removal after stapleline evaluation

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01306877

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United States, Florida
USF Tampa General Hospital Dept of Surgery
Tampa, Florida, United States, 33606
Sponsors and Collaborators
Medtronic - MITG
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Principal Investigator: Jorge Marcet, MD University of South Florida
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Responsible Party: Medtronic - MITG Identifier: NCT01306877    
Other Study ID Numbers: COVHEPH0109
First Posted: March 2, 2011    Key Record Dates
Results First Posted: October 29, 2014
Last Update Posted: October 29, 2014
Last Verified: October 2014
Keywords provided by Medtronic - MITG:
hemorrhoid stapler
Additional relevant MeSH terms:
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Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases