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Completed

NCT Number: NCT01169311

Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure

Trial Objectives

The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set:

overall performance defined by the successful creation of a normal staple line safety as measured by the 30 day incidence of adverse events.

Completed

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Key information

Conditions

Hemorrhoid Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Hemic and Lymphatic Diseases Hemorrhoids Immune System Diseases Immunoproliferative Disorders Intestinal Diseases Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Rectal Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medical Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to understand and sign Informed Consent Form
  • The participant must be 18-80 years of age.
  • The participant has (symptomatic) Grade 2-4 Hemorrhoids and is eligible for stapled hemorrhoidopexy.

Exclusion criteria

  • The procedure is needed as revision hemorrhoid surgery.
  • The participant is pregnant.
  • 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 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 is taking aspirin, anti-coagulation and/or anti platelet therapies (e.g.: Warfarin, Levonox) within the last 7 days prior to the planned surgery date
  • The participant has a history of fecal incontinence.
  • The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.

Treatment and study plan

Hemorrhoidopexy

Device

Other names: Covidien EEA Hemorrhoid and Prolapse Stapling set

Primary outcomes

  1. Uneventful Creation of a Functional Staple Line at First Firing of Device

    Time frame: about 20 minutes for procedure

    Successful creation of staple line at first firing of device during hemorrhoidopexy

Secondary outcomes

  1. OR Time

    Time frame: Day 0 - Time of stop minus time of start

    Duration of procedure

  2. Intra-Operative Bleeding Requiring Intervention

    Time frame: Day 0 - time of surgery

    Incidence of intervention for intra-operative staple-line bleeding

  3. Length of Stay

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

    length of time between time of admission and time of discharge

  4. Time to Return to Normal Activity

    Time frame: 30 days post op

  5. Incidence of Stapler Malfunction or Misfires

    Time frame: about 20 minutes for procedure

  6. Post Operative Pain

    Time frame: baseline, 30 days post op

    Post operative pain measured by 11 point visual analog scale, measured as change from baseline The scale range is 0-10, where 0 = no pain and 10 = worst possible pain

  7. Quality of Life, Physical Component

    Time frame: baseline, 30 days post op

    Physical component score SF36 scale measured as change from baseline the scoring ranges from 0 to 100 with 0 = unable to do anything while 100 = capable of physical activity without limitation

  8. Quality of Life, Mental Component

    Time frame: Baseline, 30 days post op

    quality of life, SF36 measure as change from baseline the scoring ranges from 0 to 100 with 0 = complete mental activity limitation; while 100 = capable of mental activity without limitation

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

A Prospective, Multi-Center Investigation Of The Safety And Performance Of The Covidien EEA™ Hemorrhoid And Prolapse Stapling Set With DST Series™ Technology Im A Hemorrhoidopexy Procedure

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 26, 2010
Registry last updated
Oct 6, 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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