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
About this trial
This is an interventional prevention trial for Peripheral Neuropathy focused on measuring positioning, neuropathy, trendelenburg
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.
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
NCT ID
NCT04343911
First Posted
February 13, 2020
Last Updated
April 10, 2020
Sponsor
Copenhagen University Hospital, Hvidovre
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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