Very Early Mobilization of Colorectal Surgery Patients

NCT03357497 | Completed

• 1 other identifier: 230961
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Care; Colorectal Surgery

Keywords

colorectal surgery, early mobilization, postoperative care

Outcome Measures

Primary Outcomes (1)

• Physical activity level measured with accelerometry

  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.

  72 hours

Secondary Outcomes (15)

• Time out of bed measured with a protocol

  7 days

• Minutes in the postoperative ward

  one year

• Days in the hospital ward

  one year

• Number of adverse events during the SOMS intervention.

  one day

• Blood pressure during the SOMS intervention.

  one day

Study Arms (2)

Very early mobilization

EXPERIMENTAL

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

Standard post-operative care

NO INTERVENTION

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.

Interventions

Very early mobilization OTHER

The patient will be mobilized by a physiotherapist in our postoperative care unit. The intervention uses the SOMS protocol.

Very early mobilization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Universitetssjukhuset Örebro

Örebro, 70185, Sweden

Location

Related Publications (10)

• Harper CM, Lyles YM. Physiology and complications of bed rest. J Am Geriatr Soc. 1988 Nov;36(11):1047-54. doi: 10.1111/j.1532-5415.1988.tb04375.x.

  PMID: 3049751 BACKGROUND

• 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((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.

  PMID: 23052794 BACKGROUND

• 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.

  PMID: 22594524 BACKGROUND

• 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.

  PMID: 26804821 BACKGROUND

• 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.

  PMID: 25689757 BACKGROUND

• 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.

  PMID: 23959756 BACKGROUND

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

  PMID: 12890299 BACKGROUND

• 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. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 BACKGROUND

• Keith RA, Granger CV, Hamilton BB, Sherwin FS. The functional independence measure: a new tool for rehabilitation. Adv Clin Rehabil. 1987;1:6-18. No abstract available.

  PMID: 3503663 BACKGROUND

• Thorn 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.

  PMID: 34668047 DERIVED

Study Officials

• Rebecca Ahlstrand, M.D. PhD

  Region Örebro län

  PRINCIPAL INVESTIGATOR

• Anette Forsberg, PhD

  Region Örebro län

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: November 30, 2017
• Study Start: September 25, 2017
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: November 7, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)