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Postoperative Peripheral Neuropathy After Laparoscopic Colorectal Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04343911
Enrollment
207
Registered
2020-04-13
Start date
2014-11-01
Completion date
2019-12-15
Last updated
2020-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Neuropathy, Postoperative Complications

Keywords

positioning, neuropathy, trendelenburg

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.

Interventions

DEVICEPink Pad ® (Xodus Medical Inc., New Kensington, PA)

a non-sliding foam mattress

Sponsors

Copenhagen University Hospital, Hvidovre
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
position related postoperative peripheral neuropathy24-hours after surgeryThis 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

MeasureTime frameDescription
Position related postoperative peripheral neuropathy30 day follow-up after surgeryThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026