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Completed

NCT Number: NCT04040647

Tolerance of Early Postoperative Mobilization and Ambulation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Liege, Liège, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients scheduled for colorectal or bariatric surgery within an ERP

Exclusion criteria

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

Treatment and study plan

mobilization and ambulation

Behavioral

6-min walk test (6-MWT)

Primary outcomes

  1. Number of patients with orthostatic intolerance

    Time frame: 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 outcomes

  1. 6-min walk test

    Time frame: 24 hour after surgery

    This test measures the distance covered during 6-min at normal speed

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

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

Acronym: MOBTOL

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 1, 2019
Registry last updated
May 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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