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
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, see Learn About Clinical Studies.

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 August 21, 2014