Back to resultsCan Wearable Technology Products Change Our Patient Management in Laparoscopic Colorectal Cancer Surgery
Primary Purpose
Ambulation Difficulty, Physical Examination
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mobilization recommendations
Sponsored by
About this trial
This is an interventional screening trial for Ambulation Difficulty
Eligibility Criteria
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
Sites / Locations
- Ankara University Faculty of Medicine, Surgical Oncology Department
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Mobilization Group
Arm Description
Standard treatment and mobilization recommendations will be given to this group.
Mobilization of patients will be encouraged.
Outcomes
Primary Outcome Measures
Time to start flatus
Secondary Outcome Measures
Rate of Complications
Length of stay
Rate of Mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05598294
Brief Title
Can Wearable Technology Products Change Our Patient Management in Laparoscopic Colorectal Cancer Surgery
Official Title
Can Wearable Technology Products Change Our Patient Management in Laparoscopic Colorectal Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2022 (Anticipated)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ambulation Difficulty, Physical Examination
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Standard treatment and mobilization recommendations will be given to this group.
Arm Title
Mobilization Group
Arm Type
Experimental
Arm Description
Mobilization of patients will be encouraged.
Intervention Type
Procedure
Intervention Name(s)
Mobilization recommendations
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to start flatus
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Rate of Complications
Time Frame
1 year
Title
Length of stay
Time Frame
1 year
Title
Rate of Mortality
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kamil Erozkan, Fellow
Phone
+905366154532
Email
kamilerozkan@gmail.com
Facility Information:
Facility Name
Ankara University Faculty of Medicine, Surgical Oncology Department
City
Ankara
ZIP/Postal Code
06620
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ekrem Unal, Professor
Phone
+905555137136
Email
aliekremunal@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
If requested, individual participant data (IPD) will be shared via e-mail after the reason has been evaluated.
Citations:
PubMed Identifier
30707226
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.
Results Reference
background
PubMed Identifier
3558716
Citation
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.
Results Reference
background
PubMed Identifier
24422666
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.
Results Reference
background
PubMed Identifier
32459426
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.0000000000003879.
Results Reference
result
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Can Wearable Technology Products Change Our Patient Management in Laparoscopic Colorectal Cancer Surgery
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