Pink Pad ® (Xodus Medical Inc., New Kensington, PA)
Devicea non-sliding foam mattress
NCT Number: NCT04343911
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a non-sliding foam mattress
Time frame: 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.
Time frame: 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.
Copenhagen University Hospital, Hvidovre
Other
Position-related Postoperative Peripheral Neuropathy After Laparoscopic Colorectal Surgery - a Comparative Single-center Prospective Cohort Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05623449
Nervous System Diseases, Neurologic Manifestations
Pessac, France
View Trial DetailsNCT06030297
Nervous System Diseases, Neuralgia
Palo Alto, California, United States
View Trial DetailsNCT06499129
Anxiety, Anxiety Disorders
Konya, Meram, Turkey (Türkiye)
View Trial DetailsNCT05821127
Behavior, Carpal Tunnel Syndrome
Istanbul, Turkey (Türkiye)
View Trial Details