NCT04040647

Brief Summary

Enhanced recovery programme (ERP) includes early postoperative mobilization and ambulation the day of surgery. Data suggest that orthostatic symptoms prevent a large number of patients from ambulating the day of surgery. The investigators plan to include 50 patients scheduled for colorectal surgery and bariatric surgery in an ERP. A 6-min walk test (6MWT) will be performed before surgery, 3 hour after the end of surgery, and 24 hour after surgery. The day of surgery a 2-min walk test will be realized.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

July 24, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

July 24, 2019

Last Update Submit

May 13, 2020

Conditions

Ambulation DifficultyColorectal SurgeryBariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • Number of patients with orthostatic intolerance

    orthostatic intolerance is defined as the occurrence of one of the following symptom when the patient stands up : presyncope, dizziness, nausea-vomiting, feeling of heat and blurred vision

    24 hour after surgery

Secondary Outcomes (1)

  • 6-min walk test

    24 hour after surgery

Study Arms (2)

colorectal surgery

50 consecutive patients scheduled to colorectal surgery in an enhanced recovery programme

Behavioral: mobilization and ambulation

bariatric surgery

50 consecutive patients scheduled to bariatric surgery (gastric by-pass, sleeve gastrectomy) in an enhanced recovery programme

Behavioral: mobilization and ambulation

Interventions

mobilization and ambulationBEHAVIORAL

6-min walk test (6-MWT)

bariatric surgerycolorectal surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for colorectal or bariatric surgery within an ERP

You may qualify if:

  • Patients scheduled for colorectal or bariatric surgery within an ERP

You may not qualify if:

  • Patient refusal to participate, inability to walk or stand up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Liege,

Liège, 4000, Belgium

Location

CHU Liege

Liège, 4000, Belgium

Location

Related Publications (3)

  • Eriksen JR, Munk-Madsen P, Kehlet H, Gogenur I. Orthostatic intolerance in enhanced recovery laparoscopic colorectal resection. Acta Anaesthesiol Scand. 2019 Feb;63(2):171-177. doi: 10.1111/aas.13238. Epub 2018 Aug 10.

    PMID: 30094811RESULT

  • Hanada M, Tawara Y, Miyazaki T, Sato S, Morimoto Y, Oikawa M, Niwa H, Eishi K, Nagayasu T, Eguchi S, Kozu R. Incidence of orthostatic hypotension and cardiovascular response to postoperative early mobilization in patients undergoing cardiothoracic and abdominal surgery. BMC Surg. 2017 Nov 28;17(1):111. doi: 10.1186/s12893-017-0314-y.

    PMID: 29183368RESULT

  • Skarin MU, Rice DA, McNair PJ, Kluger MT. Orthostatic intolerance following hip arthroplasty: incidence, risk factors and effect on length of stay: A prospective cohort study. Eur J Anaesthesiol. 2019 Feb;36(2):123-129. doi: 10.1097/EJA.0000000000000940.

    PMID: 30540643RESULT

MeSH Terms

Conditions

Mobility Limitation

Interventions

Walking

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Jean L Joris, MD

    Centre Hospitalier Universitaire de Liege

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Anesthesiology, chief of service

Study Record Dates

First Submitted

July 24, 2019

First Posted

August 1, 2019

Study Start

September 15, 2019

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

May 14, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)