Tolerance of Early Postoperative Mobilization and Ambulation

Bariatric Surgery Clinical Trial

— MOBTOL  

Official title:

Tolerance of Early Mobilization and Ambulation the Day of Colorectal and Bariatric Surgery in an Enhanced Recovery Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04040647
• Other study ID #: 2019/MOBTOL
• Status: Completed
• Start date: September 15, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: May 2020
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients scheduled for colorectal or bariatric surgery within an ERP

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Ambulation Difficulty
• Bariatric Surgery
• Colorectal Surgery
• Mobility Limitation

Intervention

Behavioral:
• mobilization and ambulation
6-min walk test (6-MWT)

Locations

Country	Name	City	State
Belgium	CHU Liege	Liège
Belgium	CHU Liege,	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Eriksen JR, Munk-Madsen P, Kehlet H, Gögenur 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. — View 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 abd — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6-min walk test	This test measures the distance covered during 6-min at normal speed	24 hour after surgery