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Postoperative Peripheral Neuropathy After Laparoscopic Colorectal Surgery

Primary Purpose

Peripheral Neuropathy, Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pink Pad ® (Xodus Medical Inc., New Kensington, PA)
Sponsored by
Copenhagen University Hospital, Hvidovre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peripheral Neuropathy focused on measuring positioning, neuropathy, trendelenburg

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >18 years
  • Elective laparoscopic colorectal surgery
  • Sufficient written and verbal Danish skills
  • Awake, responsive and oriented in the post-surgical inclusion period

Exclusion Criteria:

  • Pre-existing peripheral neuro- or musculopathy,
  • Conversion to open operation
  • Lack of consent were defined as exclusion criteria.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    conventional positioning

    positioning on Pink Pad ®

    Arm Description

    positioning with shoulder braces

    Outcomes

    Primary Outcome Measures

    position related postoperative peripheral neuropathy
    This study's primary outcome is to evaluated the incidence of postoperative peripheral neuropathy in patients positioned conventionally compared to patients positioned on the Pink Pad foam mattress 24-hours after surgery.

    Secondary Outcome Measures

    Position related postoperative peripheral neuropathy
    The secondary outcome of this study is to evaluate the incidence of postoperative peripheral neuropathy in patients positioned conventionally compared to patients positioned on the Pink Pad foam mattress 30 days after surgery.

    Full Information

    First Posted
    February 13, 2020
    Last Updated
    April 10, 2020
    Sponsor
    Copenhagen University Hospital, Hvidovre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04343911
    Brief Title
    Postoperative Peripheral Neuropathy After Laparoscopic Colorectal Surgery
    Official Title
    Position-related Postoperative Peripheral Neuropathy After Laparoscopic Colorectal Surgery - a Comparative Single-center Prospective Cohort Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2014 (Actual)
    Primary Completion Date
    June 30, 2015 (Actual)
    Study Completion Date
    December 15, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Copenhagen University Hospital, Hvidovre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This prospective cohort study of patients undergoing colorectal surgery positioned conventionally with shoulder braces was performed. After initial results the implementation of the Pink Pad ® took place in order to compare the two groups. This study favours Pink Pad over conventional positioning concerning postoperative neuropathy.
    Detailed Description
    Laparoscopic colorectal surgery requires perioperative positioning in the dorsal lithotomy position and intermittent Trendelenburg position, which is associated with postoperative peripheral neuropathy, which is a substantial cause of anesthesia-related claims. This study aims to primarily assess the incidence of postoperative peripheral neuropathy of patients positioned conventionally by shoulder braces and secondly to compare this group with patients positioned on the foam mattress Pink Pad ® 24-hours after surgery and secondarily at a 30-day postoperative follow-up. This consecutive single-center prospective cohort study of 155 patients undergoing colorectal surgery was performed between November 2014 and June 2015. After initial results the implementation of the Pink Pad ® took place and a total of 52 patients were included between May 2016 and February 2017 in order to compare the two groups. Position related postoperative peripheral neuropathy is an important complication after laparoscopic colorectal surgery. This study concludes that careful attention should be payed to positioning and favors Pink Pad ® over conventional positioning with shoulder braces.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Neuropathy, Postoperative Complications
    Keywords
    positioning, neuropathy, trendelenburg

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    207 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    conventional positioning
    Arm Type
    No Intervention
    Arm Description
    positioning with shoulder braces
    Arm Title
    positioning on Pink Pad ®
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Pink Pad ® (Xodus Medical Inc., New Kensington, PA)
    Intervention Description
    a non-sliding foam mattress
    Primary Outcome Measure Information:
    Title
    position related postoperative peripheral neuropathy
    Description
    This study's primary outcome is to evaluated the incidence of postoperative peripheral neuropathy in patients positioned conventionally compared to patients positioned on the Pink Pad foam mattress 24-hours after surgery.
    Time Frame
    24-hours after surgery
    Secondary Outcome Measure Information:
    Title
    Position related postoperative peripheral neuropathy
    Description
    The secondary outcome of this study is to evaluate the incidence of postoperative peripheral neuropathy in patients positioned conventionally compared to patients positioned on the Pink Pad foam mattress 30 days after surgery.
    Time Frame
    30 day follow-up after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age >18 years Elective laparoscopic colorectal surgery Sufficient written and verbal Danish skills Awake, responsive and oriented in the post-surgical inclusion period Exclusion Criteria: Pre-existing peripheral neuro- or musculopathy, Conversion to open operation Lack of consent were defined as exclusion criteria.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Signe AW Laursen, MD
    Organizational Affiliation
    Copenhagen University Hospital, Hvidovre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Postoperative Peripheral Neuropathy After Laparoscopic Colorectal Surgery

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