Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids

Hemorrhoids Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306877
• Other study ID #: COVHEPH0109
• Status: Completed
• Phase: N/A
• First received: January 28, 2011
• Last updated: October 24, 2014
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: October 2014
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: January 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

Device:
• EEA Hemorrhoid and Prolapse Stapling Set
Surgical device
• Endosurgery Proximate PPH03 Stapling Set
Surgical device

Locations

Country	Name	City	State
United States	USF Tampa General Hospital Dept of Surgery	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Location of the Staple Line	Distance of staple line to dentate line as measure by surgical ruler	Day 0	No
Secondary	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	No
Secondary	Operative Room (OR) Time	Time of insertion of anoscope to time of anoscope removal after stapleline evaluation	Day 0	No