Tolerance of Early Postoperative Mobilization and Ambulation

Completed

• Conditions: Bariatric Surgery; Ambulation Difficulty; Colorectal Surgery
• Interventions: Behavioral: mobilization and ambulation

• Registration Number: NCT04040647
• Lead Sponsor: University of Liege

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.

Study Timeline

• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-07-30
• Study First Posted: 2019-08-01
• Study Start: 2019-09-15
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-13
• Last Update Posted: 2020-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Patients scheduled for colorectal or bariatric surgery within an ERP

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
colorectal surgery	mobilization and ambulation	50 consecutive patients scheduled to colorectal surgery in an enhanced recovery programme
bariatric surgery	mobilization and ambulation	50 consecutive patients scheduled to bariatric surgery (gastric by-pass, sleeve gastrectomy) in an enhanced recovery programme

Primary Outcome Measures

Name	Time	Method
Number of patients with orthostatic intolerance	24 hour after surgery	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

Secondary Outcome Measures

Name	Time	Method
6-min walk test	24 hour after surgery	This test measures the distance covered during 6-min at normal speed

Trial Locations

Locations (2)

CHU Liege; 🇧🇪 Liège, Belgium

CHU Liege,; 🇧🇪 Liège, Belgium