NCT04343911

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2015

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

8 months

First QC Date

February 13, 2020

Last Update Submit

April 10, 2020

Conditions

Peripheral NeuropathyPostoperative Complications

Keywords

positioningneuropathytrendelenburg

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Position related postoperative peripheral neuropathy

    30 day follow-up after surgery

Study Arms (2)

conventional positioning

NO INTERVENTION

positioning with shoulder braces

positioning on Pink Pad ®

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

Interventions

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

a non-sliding foam mattress

positioning on Pink Pad ®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Elective laparoscopic colorectal surgery
  • Sufficient written and verbal Danish skills

You may not qualify if:

  • Pre-existing peripheral neuro- or musculopathy,
  • Conversion to open operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peripheral Nervous System DiseasesPostoperative Complications

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Signe AW Laursen, MD

    Copenhagen University Hospital, Hvidovre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and Specialist Registrar in Anesthesiology

Study Record Dates

First Submitted

February 13, 2020

First Posted

April 13, 2020

Study Start

November 1, 2014

Primary Completion

June 30, 2015

Study Completion

December 15, 2019

Last Updated

April 13, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share