Postoperative Peripheral Neuropathy After Laparoscopic Colorectal Surgery

Study Overview
=================
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.

Official Title
-----------------
Position-related Postoperative Peripheral Neuropathy After Laparoscopic Colorectal Surgery - a Comparative Single-center Prospective Cohort Study

Conditions
-----------------
Peripheral Neuropathy, Postoperative Complications

Intervention / Treatment
-----------------
* Device: Pink Pad ® (Xodus Medical Inc., New Kensington, PA)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: conventional positioning<br>positioning with shoulder braces | |
| Active Comparator: positioning on Pink Pad ®<br> | Device: Pink Pad ® (Xodus Medical Inc., New Kensington, PA)<br>* a non-sliding foam mattress<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24-hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 day follow-up after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
positioning, neuropathy, trendelenburg