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

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)

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 Overview

• Status: Completed
• Conditions: Hemorrhoids
• Intervention / Treatment: Device: EEA Hemorrhoid and Prolapse Stapling Set; Device: Endosurgery Proximate PPH03 Stapling Set

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • USF Tampa General Hospital Dept of Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0 - time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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.	Day 0, 1 week, 2 week, 1 month, 3 month, 6 month
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	Day 0 minus 60, 1 week, 1 month, 3 months, 6 months
Location of the Staple Line	Distance of staple line to dentate line as measure by surgical ruler	Day 0
Length of Stay	Length of hospital stay is defined as time of anoscope insertion until discharge	Day 0 time of discharge minus time of admission
Operative Room (OR) Time	Time of insertion of anoscope to time of anoscope removal after stapleline evaluation	Day 0

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Jorge Marcet, MD, University of South Florida

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: January 28, 2011
• First Submitted That Met QC Criteria: February 28, 2011
• First Posted (ESTIMATE): March 2, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 29, 2014
• Last Update Submitted That Met QC Criteria: October 24, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: hemorrhoid; hemorrhoid stapler
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids
• Other Study ID Numbers: COVHEPH0109