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

NCT05598294 | Unknown

• 1 other identifier: AnkaraUSurgOnc
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Ambulation Difficulty; Physical Examination

Outcome Measures

Primary Outcomes (1)

• Time to start flatus

  1 year

Secondary Outcomes (3)

• Rate of Complications

  1 year

• Length of stay

  1 year

• Rate of Mortality

  1 year

Study Arms (2)

Control Group

NO INTERVENTION

Standard treatment and mobilization recommendations will be given to this group.

Mobilization Group

EXPERIMENTAL

Mobilization of patients will be encouraged.

Procedure: Mobilization recommendations

Interventions

Mobilization recommendations PROCEDURE

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.

Mobilization Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (2)

Ankara University Faculty of Medicine, Surgical Oncology Department

Ankara, 06620, Turkey (Türkiye)

NOT YET RECRUITING

Ankara University

Ankara, 06620, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 30707226 BACKGROUND

• 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.

  PMID: 3558716 BACKGROUND

• 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.

  PMID: 24422666 BACKGROUND

• 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.

  PMID: 32459426 RESULT

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kamil Erozkan, Fellow

CONTACT

+905366154532; kamilerozkan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 28, 2022
• Study Start: October 10, 2022
• Primary Completion: November 15, 2024
• Study Completion: December 15, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)