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Completed

NCT Number: NCT01306877

Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids

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.

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Key information

Conditions

Hemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USF Tampa General Hospital Dept of Surgery

Tampa, Florida, 33606, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EEA Hemorrhoid and Prolapse Stapling Set

Device

Surgical device

Endosurgery Proximate PPH03 Stapling Set

Device

Surgical device

Primary outcomes

  1. Intraoperative Bleeding

    Time frame: 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 outcomes

  1. Post Operative Pain - (PI-NIRS)

    Time frame: 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.

  2. Post-Operative Pain (Analgesic Intake)

    Time frame: 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.

  3. Overall Quality of Life - General Health Score

    Time frame: 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

  4. Location of the Staple Line

    Time frame: Day 0

    Distance of staple line to dentate line as measure by surgical ruler

  5. Length of Stay

    Time frame: Day 0 time of discharge minus time of admission

    Length of hospital stay is defined as time of anoscope insertion until discharge

  6. Operative Room (OR) Time

    Time frame: Day 0

    Time of insertion of anoscope to time of anoscope removal after stapleline evaluation

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study 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)

Acronym: HEMOSTASIS

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Mar 2, 2011
Registry last updated
Oct 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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