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

NCT ID: NCT05598294

Last Updated: 2024-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-10

Study Completion Date

2024-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Ambulation Difficulty Physical Examination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Mobilization Group

Mobilization of patients will be encouraged.

Group Type EXPERIMENTAL

Mobilization recommendations

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Kamil Erozkan

Clinical Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara University Faculty of Medicine, Surgical Oncology Department

Ankara, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Ankara University

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Kamil Erozkan, Fellow

Role: CONTACT

+905366154532

Facility Contacts

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Ali Ekrem Unal, Professor

Role: primary

+905555137136

Ali Ekrem Unal, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 30707226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3558716 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24422666 (View on PubMed)

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.

Reference Type RESULT
PMID: 32459426 (View on PubMed)

Other Identifiers

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AnkaraUSurgOnc

Identifier Type: -

Identifier Source: org_study_id

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