Clinical trial NCT04040647: Tolerance of Early Postoperative Mobilization and Ambulation
Official title: Tolerance of Early Mobilization and Ambulation the Day of Colorectal and Bariatric Surgery in an Enhanced Recovery Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ambulation Difficulty
Colorectal Surgery
Bariatric Surgery
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for colorectal or bariatric surgery within an ERP

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.

Detailed description: 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 (up to 50%) from ambulating the day of surgery.

The investigators plan to include 50 patients scheduled for colorectal surgery and bariatric surgery in an ERP.

The primary endpoint will be the ability to get out of the bed and sit in an armchair. Orthostatic symptom will be recorded. The secondary endpoint will be a 6-min walk test (6-MWT). This test 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 (2-MWT) will be realized.

Correlation of the ability to early ambulate and postoperative course (adherence to ERP, complications) will be analyzed.

Eligibility criteria: Inclusion Criteria:

Patients scheduled for colorectal or bariatric surgery within an ERP

Exclusion Criteria:

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

Primary outcomes:
measure: Number of patients with orthostatic intolerance
timeFrame: 24 hour after surgery
Secondary outcomes:
measure: 6-min walk test
timeFrame: 24 hour after surgery
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU Liege,
city: Liège
country: Belgium
facility: CHU Liege
Study officials:
affiliation: Centre Hospitalier Universitaire de Liege
name: Jean L Joris, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.