Very Early Mobilization of Colorectal Surgery Patients

• ClinicalTrials.gov Identifier: NCT03357497
• Recruitment Status: Completed
• First Posted: November 30, 2017
• Last Update Posted: November 7, 2019
• Sponsor: Region Örebro County
• Information provided by (Responsible Party): Region Örebro County

Study Description

Brief Summary:

Early mobilization is an important part of Enhanced Recovery Programs (ERP)in colorectal surgery. The aim of this randomized controlled trial is to investigate the impact of very early mobilization, starting within 1 hour after surgery, on further mobilization within an existing Enhanced Recovery Program.

Condition or disease	Intervention/treatment	Phase
Postoperative Care; Colorectal Surgery	Other: Very early mobilization	Not Applicable

Detailed Description:

Post-operative bed rest and immobility has a negative effect on morbidity and mortality after colorectal surgery.To prevent immobilization early mobilization is a well established part of Enhanced Recovery Programs. This facility uses protocols developed by the ERAS (Enhanced Recovery After Surgery)-society. However not all patients can reach the level physical activity needed to be in compliance with the ERP. This being more frequent in the elderly frail patient. This may contribute to longer hospital stay and increase the risk of complications. The aim of this trial is to investigate if a very early mobilization intervention will lead to a higher lever of physical activity after surgery compared with standard-care.

The aim is to include 150 patients scheduled to undergo colorectal surgery. Patients will receive written and verbal information about the trial before written consent is obtained. The patients will undergo an extended pre-operative assessment during which a baseline for patients physical activity level will be established before surgery. For this purpose the patients will be evaluated by a physiotherapist with the following tools; 6-minutes walk test, Timed up and go-test (TUG), mini modified Functional Independence Measure (mFIM), WHO disability assessment score (WHODAS) and activity measurement with accelerometry for up to 7 days. (Actigraph GT3X device)

The randomization will take place on the day of the surgery and the patients will be assigned to either intervention (very early mobilization) or control group (standard post-operative care). A stratified randomization will be performed to ensure an even spread within three patient categories: Laparoscopic surgery, Open surgery and Rectum amputation. The randomization is performed using concealed allocation where envelopes are prepared externally using a randomization list prepared by a statistician.

After surgery the patients will be transferred to the post-operative care unit where the patients included in the intervention group will be mobilized with the help of a physiotherapist and post-operative unit staff. The intervention will begin as early as 30 minutes after arrival in the post-operative unit. The intervention will follow the Surgical ICU Optimal Mobilization Score (SOMS) which includes four steps of mobilization from movement in bed up to walking. Progress from each step to the next will be conditioned with patient fulfilling criteria for a safe mobilization including stable physiological parameters and adequate pain situation. The patients in the standard care group will not receive the intervention.

All patients will receive information about early mobilization. The patients will not receive information on the timing of the mobilization intervention in an effort to remain blinded to the intervention. The patient in the standard care group will be mobilized accordingly to the ERP protocol, which also includes early mobilization in the surgical ward. Upon transfer from the post-operative unit to the surgical ward all study patients will be again fitted with the activity monitor to measure their physical activity during the post-operative phase.

During hospital stay all study patients will be subject to routine mobilization within the existing ERP protocol. To determine the physical activity level the patient will be wearing the activity monitoring device until discharge from the surgical ward. The study patients will also be evaluated by blinded physiotherapists with mFIM and 6 minutes walk-test. In addition information will be gathered regarding routine documentation on patient mobilization progress to measure adherence to ERP goals.

After four to six weeks the patients are scheduled for a standard post-operative follow-up visit. The study patients will then also meet a blinded physiotherapist that previously was not participating in the intervention who will repeat the following tests: 6 minutes walk-test, WHODAS, TUG. All study patients will also be instructed to wear the activity monitor for additional seven days to again measure their physical activity level. All patients who have undergone the intervention will be scheduled for a semi-structured telephone interview about their perception of the SOMS intervention.

Follow-up questionnaire with WHODAS self-reported questions will be gathered through a telephone interview with the patients three, six and twelve months after surgery.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 146 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Very Early Mobilization of Colorectal Surgery Patients - A Randomized Controlled Trial
• Actual Study Start Date: September 25, 2017
• Actual Primary Completion Date: May 30, 2019
• Actual Study Completion Date: May 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Very early mobilization; This group will be mobilized in the post-operative unit by a designated physiotherapist. The intervention will be conducted accordingly with the SOMS protocol.	Other: Very early mobilization; The patient will be mobilized by a physiotherapist in our postoperative care unit. The intervention uses the SOMS protocol.
No Intervention: Standard post-operative care; This group will receive standard post-operative care. Mobilization will only take place if the patient request it or to facilitate god post-operative care.

Outcome Measures

Primary Outcome Measures :

1. Physical activity level measured with accelerometry [ Time Frame: 72 hours ]
   Comparison between intervention and standard-care group by measurements of physical activity level with an accelerometer that the patient wears during the day. The accelerometer is worn at hip level.

Secondary Outcome Measures :

1. Time out of bed measured with a protocol [ Time Frame: 7 days ]
   Comparison between intervention and standard-care group, analysis of time out of bed and thus compliance to ERP goals using written documentation in the surgical ward.
2. Minutes in the postoperative ward [ Time Frame: one year ]
   To ascertain if this intervention is cost effective by comparing time in the post-operative unit between intervention and standard care group.
3. Days in the hospital ward [ Time Frame: one year ]
   To ascertain if this intervention is cost effective by comparing total hospital stay time between intervention and standard care group.
4. Number of adverse events during the SOMS intervention. [ Time Frame: one day ]
   Frequency of adverse events during the intervention using the SOMS-protocol. Adverse events here are abnormal blood pressure, pulse, oxygen saturation %, respiratory rate, pain, presence of vertigo, presence of nausea and vomiting.
5. Blood pressure during the SOMS intervention. [ Time Frame: one day ]
   Blood pressure are registered during the intervention.
6. Pulse during the SOMS intervention. [ Time Frame: one day ]
   Number of heartbeats are registered during the intervention with a device on the patients finger.
7. Oxygen saturation during the SOMS intervention. [ Time Frame: one day ]
   Oxygen saturation are registered during the intervention with a device on the patients finger.
8. Pain [ Time Frame: one day ]
   Pain experienced by the patient during the SOMS intervention, rated using a Visual analogue scale 0-100.
9. Presence of vertigo [ Time Frame: one day ]
   Vertigo experienced by the patient during the SOMS intervention, presence rated as yes/no.
10. Presence of nausea [ Time Frame: one day ]
    Nausea experienced by the patient during the SOMS intervention, presence rated as yes/no. If patient vomits due to nausea is also rated yes/no.
11. 6 minute Walking test [ Time Frame: 6 weeks ]
    Physical capacity measured with the 6 minute Walking test. The number of meters a patient walks during 6 minutes.
12. Timed up and Go (TUG) test [ Time Frame: 6 weeks ]
    Test of functional mobility. The patient sits on a chair, rises and walks 3 meters, turns och walks back and sits down on the chair. Time in seconds to perform the test.
13. Patient perception of the SOMS intervention [ Time Frame: 6 weeks ]
    Semi structured telephone interview with patients in the intervention group about their perception of the intervention.
14. Severity of post-operative complications [ Time Frame: one year ]
    Monitoring number and frequency of patient complications with review of patient records using Clavien-Dindo complication classification
15. Self-perceived health and physical function level one year after surgery [ Time Frame: one year ]
    Using the WHODAS questionnaire, self-reported

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• All patients over the age of 18 scheduled for colorectal surgery

Exclusion Criteria:

• Unable to understand study information (language,cognitive impairment, etc.)
• Unable to walk

Contacts and Locations

Locations

Sweden

Universitetssjukhuset Örebro

Örebro, Sweden, 70185

Sponsors and Collaborators

Region Örebro County

Investigators

• Principal Investigator: Rebecca Ahlstrand, M.D. PhD; Region Örebro Län
• Principal Investigator: Anette Forsberg, PhD; Region Örebro Län

More Information

Publications:

Harper CM, Lyles YM. Physiology and complications of bed rest. J Am Geriatr Soc. 1988 Nov;36(11):1047-54. Review.

Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS(®)) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0.

Smart NJ, White P, Allison AS, Ockrim JB, Kennedy RH, Francis NK. Deviation and failure of enhanced recovery after surgery following laparoscopic colorectal surgery: early prediction model. Colorectal Dis. 2012 Oct;14(10):e727-34. doi: 10.1111/j.1463-1318.2012.03096.x.

Castelino T, Fiore JF Jr, Niculiseanu P, Landry T, Augustin B, Feldman LS. The effect of early mobilization protocols on postoperative outcomes following abdominal and thoracic surgery: A systematic review. Surgery. 2016 Apr;159(4):991-1003. doi: 10.1016/j.surg.2015.11.029. Epub 2016 Jan 21.

Shulman MA, Myles PS, Chan MT, McIlroy DR, Wallace S, Ponsford J. Measurement of disability-free survival after surgery. Anesthesiology. 2015 Mar;122(3):524-36. doi: 10.1097/ALN.0000000000000586.

Meyer MJ, Stanislaus AB, Lee J, Waak K, Ryan C, Saxena R, Ball S, Schmidt U, Poon T, Piva S, Walz M, Talmor DS, Blobner M, Latronico N, Eikermann M. Surgical Intensive Care Unit Optimal Mobilisation Score (SOMS) trial: a protocol for an international, multicentre, randomised controlled trial focused on goal-directed early mobilisation of surgical ICU patients. BMJ Open. 2013 Aug 19;3(8):e003262. doi: 10.1136/bmjopen-2013-003262.

Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5. Review.

Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8.

Keith RA, Granger CV, Hamilton BB, Sherwin FS. The functional independence measure: a new tool for rehabilitation. Adv Clin Rehabil. 1987;1:6-18.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Thörn RW, Stepniewski J, Hjelmqvist H, Forsberg A, Ahlstrand R, Ljungqvist O. Supervised Immediate Postoperative Mobilization After Elective Colorectal Surgery: A Feasibility Study. World J Surg. 2022 Jan;46(1):34-42. doi: 10.1007/s00268-021-06347-2. Epub 2021 Oct 19.

• Responsible Party: Region Örebro County
• ClinicalTrials.gov Identifier: NCT03357497
• Other Study ID Numbers: 230961
• First Posted: November 30, 2017
• Last Update Posted: November 7, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Region Örebro County:

colorectal surgery, early mobilization, postoperative care