Postoperative Peripheral Neuropathy After Laparoscopic Colorectal Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Peripheral Neuropathy
• Intervention / Treatment: Device: Pink Pad ® (Xodus Medical Inc., New Kensington, PA)

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.

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital, Hvidovre
• Investigators: Principal Investigator: Signe AW Laursen, MD, Copenhagen University Hospital, Hvidovre

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): June 30, 2015
• Study Completion (Actual): December 15, 2019

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 10, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: neuropathy; positioning; trendelenburg
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Postoperative Complications
• Other Study ID Numbers: 44954

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No