Postoperative Peripheral Neuropathy After Laparoscopic Colorectal Surgery

Copenhagen University Hospital, Hvidovre

Status: Completed

Conditions: Postoperative Complications; Peripheral Neuropathy

Treatments: Device: Pink Pad ® (Xodus Medical Inc., New Kensington, PA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04343911

44954

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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207 participants in 2 patient groups

conventional positioning

No Intervention group

Description:

positioning with shoulder braces

positioning on Pink Pad ®

Active Comparator group

Treatment:

Device: Pink Pad ® (Xodus Medical Inc., New Kensington, PA)