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: July 18, 2013
Last verified: July 2013
  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 Phase
Hemorrhoids
Device: EEA Hemorrhoid and Prolapse Stapling Set
Device: Endosurgery Proximate PPH03 Stapling Set
Phase 4

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: Intraoperative period (January 2011- March 2012) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Post operative pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Overall quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Location of the staple line [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of patients with device related adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Length of stay [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Operative Room (OR) time [ Time Frame: Intraoperative period (January 2011- March 2012) ] [ Designated as safety issue: No ]

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
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
Last Updated: July 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Covidien:
hemorrhoid
hemorrhoid stapler

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

ClinicalTrials.gov processed this record on April 20, 2014