Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids

Not Applicable

Completed

Interventions: Device: EEA Hemorrhoid and Prolapse Stapling Set
Device: Endosurgery Proximate PPH03 Stapling Set

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.

Recruitment & 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.

Arm && Interventions

Group	Intervention	Description
EEA Hemorrhoid and Prolapse Stapling Set	EEA Hemorrhoid and Prolapse Stapling Set	-
Endosurgery Proximate PPH03 Stapling Set	Endosurgery Proximate PPH03 Stapling Set	-

Primary Outcome Measures

Name	Time	Method
Intraoperative Bleeding	Day 0 - time of surgery	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

Name	Time	Method
Length of Stay	Day 0 time of discharge minus time of admission	Length of hospital stay is defined as time of anoscope insertion until discharge
Operative Room (OR) Time	Day 0	Time of insertion of anoscope to time of anoscope removal after stapleline evaluation
Post Operative Pain - (PI-NIRS)	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 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)	Day 0, 1 week, 2 week, 1 month, 3 month, 6 month	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	Day 0 minus 60, 1 week, 1 month, 3 months, 6 months	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	Day 0	Distance of staple line to dentate line as measure by surgical ruler