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

Primary Purpose

Hemorrhoids

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EEA Hemorrhoid and Prolapse Stapling Set
Endosurgery Proximate PPH03 Stapling Set
Sponsored by
Medtronic - MITG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhoids focused on measuring hemorrhoid, hemorrhoid stapler

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • USF Tampa General Hospital Dept of Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EEA Hemorrhoid and Prolapse Stapling Set

Endosurgery Proximate PPH03 Stapling Set

Arm Description

Outcomes

Primary Outcome Measures

Intraoperative Bleeding
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)
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)
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
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
Distance of staple line to dentate line as measure by surgical ruler
Length of Stay
Length of hospital stay is defined as time of anoscope insertion until discharge
Operative Room (OR) Time
Time of insertion of anoscope to time of anoscope removal after stapleline evaluation

Full Information

First Posted
January 28, 2011
Last Updated
October 24, 2014
Sponsor
Medtronic - MITG
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1. Study Identification

Unique Protocol Identification Number
NCT01306877
Brief Title
Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids
Acronym
HEMOSTASIS
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

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoids
Keywords
hemorrhoid, hemorrhoid stapler

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EEA Hemorrhoid and Prolapse Stapling Set
Arm Type
Experimental
Arm Title
Endosurgery Proximate PPH03 Stapling Set
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
EEA Hemorrhoid and Prolapse Stapling Set
Intervention Description
Surgical device
Intervention Type
Device
Intervention Name(s)
Endosurgery Proximate PPH03 Stapling Set
Intervention Description
Surgical device
Primary Outcome Measure Information:
Title
Intraoperative Bleeding
Description
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.
Time Frame
Day 0 - time of surgery
Secondary Outcome Measure Information:
Title
Post Operative Pain - (PI-NIRS)
Description
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.
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
Title
Post-Operative Pain (Analgesic Intake)
Description
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.
Time Frame
Day 0, 1 week, 2 week, 1 month, 3 month, 6 month
Title
Overall Quality of Life - General Health Score
Description
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
Time Frame
Day 0 minus 60, 1 week, 1 month, 3 months, 6 months
Title
Location of the Staple Line
Description
Distance of staple line to dentate line as measure by surgical ruler
Time Frame
Day 0
Title
Length of Stay
Description
Length of hospital stay is defined as time of anoscope insertion until discharge
Time Frame
Day 0 time of discharge minus time of admission
Title
Operative Room (OR) Time
Description
Time of insertion of anoscope to time of anoscope removal after stapleline evaluation
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Marcet, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
USF Tampa General Hospital Dept of Surgery
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids

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