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

Ambulation Difficulty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598294
• Other study ID #: AnkaraUSurgOnc
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: December 15, 2024

Study information

• Verified date: January 2024
• Source: Ankara University
• Contact: Kamil Erozkan, Fellow
• Phone: +905366154532
• Email: kamilerozkan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ambulation Difficulty
• Mobility Limitation
• Physical Examination

Intervention

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.

Locations

Country	Name	City	State
Turkey	Ankara University	Ankara
Turkey	Ankara University Faculty of Medicine, Surgical Oncology Department	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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. — View Citation

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.000000 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to start flatus		1 year
Secondary	Rate of Complications		1 year
Secondary	Length of stay		1 year
Secondary	Rate of Mortality		1 year