Can Wearable Technology Products Change Our Patient Management in Laparoscopic Colorectal Cancer Surgery

The clinical progress of the patients whose mobilization the investigators follow up with wearable technology products will be observed in the early postoperative period until discharge. In this way, the investigators primarily aim to examine whether the bowel movements of our more mobilized patients return earlier.

Study Overview

• Status: Recruiting
• Conditions: Ambulation Difficulty; Physical Examination
• Intervention / Treatment: Procedure: Mobilization recommendations

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kamil Erozkan, Fellow; Phone Number: +905366154532; Email: kamilerozkan@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06620
    • Not yet recruiting
    • Ankara University Faculty of Medicine, Surgical Oncology Department
    • Contact: Ali Ekrem Unal, Professor; Phone Number: +905555137136; Email: aliekremunal@yahoo.com
  • Ankara, Turkey, 06620
    • Recruiting
    • Ankara University
    • Contact: Ali Ekrem Unal, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients who underwent laparoscopic abdominal surgery
• Colorectal cancer patients
• Curative surgeries
• Stage 0,1,2,3 patients

Exclusion Criteria:

• Patients who cannot walk
• Patients converted to open procedure
• Patients with ostomy
• Patients for whom laparoscopy is contraindicated
• Palliative surgeries
• Patients with distant organ metastases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Standard treatment and mobilization recommendations will be given to this group.
Experimental: Mobilization Group; Mobilization of patients will be encouraged.	Procedure: Mobilization recommendations; Standard mobilization recommendations will be given to all patients, and feedback will be given to the intervention group to increase the number of steps 4 times a day according to the daily targeted number of steps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to start flatus	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of stay	1 year
Rate of Complications	1 year
Rate of Mortality	1 year

Collaborators and Investigators

• Sponsor: Ankara University

Publications and helpful links

General Publications

• Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
• Daskivich TJ, Houman J, Lopez M, Luu M, Fleshner P, Zaghiyan K, Cunneen S, Burch M, Walsh C, Paiement G, Kremen T, Soukiasian H, Spitzer A, Jackson T, Kim HL, Li A, Spiegel B. Association of Wearable Activity Monitors With Assessment of Daily Ambulation and Length of Stay Among Patients Undergoing Major Surgery. JAMA Netw Open. 2019 Feb 1;2(2):e187673. doi: 10.1001/jamanetworkopen.2018.7673.
• Heron N, Tully MA, McKinley MC, Cupples ME. Physical activity assessment in practice: a mixed methods study of GPPAQ use in primary care. BMC Fam Pract. 2014 Jan 15;15:11. doi: 10.1186/1471-2296-15-11.
• Ganer Herman H, Kleiner I, Tairy D, Gonen N, Ben Zvi M, Kovo M, Bar J, Weiner E. Effect of Digital Step Counter Feedback on Mobility After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2020 Jun;135(6):1345-1352. doi: 10.1097/AOG.0000000000003879.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Estimated): November 15, 2024
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mobility Limitation
• Other Study ID Numbers: AnkaraUSurgOnc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: If requested, individual participant data (IPD) will be shared via e-mail after the reason has been evaluated.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No