Trials / Completed
CompletedNCT04343911
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 207 (actual)
- Sponsor
- Copenhagen University Hospital, Hvidovre · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pink Pad ® (Xodus Medical Inc., New Kensington, PA) | a non-sliding foam mattress |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2015-06-30
- Completion
- 2019-12-15
- First posted
- 2020-04-13
- Last updated
- 2020-04-13
Source: ClinicalTrials.gov record NCT04343911. Inclusion in this directory is not an endorsement.