Postoperative Peripheral Neuropathy After Laparoscopic Colorectal Surgery

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04343911
• Other study ID #: 44954
• Status: Completed
• Phase: N/A
• Start date: November 1, 2014
• Est. completion date: December 15, 2019

Study information

• Verified date: April 2020
• Source: Copenhagen University Hospital, Hvidovre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: December 15, 2019
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Postoperative Complications

Intervention

Device:
• Pink Pad ® (Xodus Medical Inc., New Kensington, PA)
a non-sliding foam mattress

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen University Hospital, Hvidovre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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