Postoperative Peripheral Neuropathy After Laparoscopic Colorectal Surgery

Not Applicable

Completed

• Conditions: Postoperative Complications; Peripheral Neuropathy
• Interventions: Device: Pink Pad ® (Xodus Medical Inc., New Kensington, PA)

• Registration Number: NCT04343911
• Lead Sponsor: Copenhagen University Hospital, Hvidovre

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.

Study Timeline

• Study Start: 2014-11-01
• Primary Completion: 2015-06-30
• Study Completion: 2019-12-15
• Study First Submitted: 2020-02-13
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-10
• Last Update Submitted: 2020-04-10
• Study First Posted: 2020-04-13
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
positioning on Pink Pad ®	Pink Pad ® (Xodus Medical Inc., New Kensington, PA)	-

Primary Outcome Measures

Name	Time	Method
position related postoperative peripheral neuropathy	24-hours after surgery	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

Name	Time	Method
Position related postoperative peripheral neuropathy	30 day follow-up after surgery	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.