Ambulation DifficultyNCT05598294
Can Wearable Technology Products Change Our Patient Management in Laparoscopic Colorectal Cancer Surgery
A study testing Mobilization recommendations in people with Ambulation Difficulty and Physical Examination, run by Ankara University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ambulation Difficulty, Physical Examination
- What is being tested?
- Mobilization recommendations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Oct 2022to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent laparoscopic abdominal surgery
- Colorectal cancer patients
- Curative surgeries
- Stage 0,1,2,3 patients
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Ankara University Faculty of Medicine, Surgical Oncology Department
Ankara, 06620
Ali Ekrem Unal, Professor, +905555137136, aliekremunal@yahoo.com
- Recruiting
Ankara University
Ankara, 06620
Ali Ekrem Unal, MD
About this study
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
- Being tested
- Mobilization recommendations
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization recommendationsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Standard treatment and mobilization recommendations will be given to this group. |
| Mobilization Group | Experimental | Mobilization of patients will be encouraged. Receives: Procedure: Mobilization recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to start flatus
Measured: 1 year
Secondary outcomes (3)
Rate of Complications
Measured: 1 year
Length of stay
Measured: 1 year
Rate of Mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start10 Oct 2022
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ambulation DifficultyStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamil Erozkan, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598294
- Sponsor's protocol ID
- AnkaraUSurgOnc
- Status last verified
- Jan 2024
- First submitted
- 25 Oct 2022
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If requested, individual participant data (IPD) will be shared via e-mail after the reason has been evaluated.
Publications
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.
PubMed 30707226Charlson 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.
PubMed 3558716Heron 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.
PubMed 24422666Ganer 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.
PubMed 32459426
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Wearable Technology Products Change Our Patient Management in Laparoscopic Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT05598294
- Acronym / sponsor ID
- AnkaraUSurgOnc
- Conditions
- Ambulation Difficulty, Physical Examination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Standard treatment and mobilization recommendations will be given to this group. |
| Mobilization Group | Experimental | Procedure: Mobilization recommendationsMobilization of patients will be encouraged. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who underwent laparoscopic abdominal surgery
- Colorectal cancer patients
- Curative surgeries
- Stage 0,1,2,3 patients
Key exclusion criteria (6 listed)
- Patients who cannot walk
- Patients converted to open procedure
- Patients with ostomy
- Patients for whom laparoscopy is contraindicated
- Palliative surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobilization recommendationsStandard 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. | Procedure or surgery | Mobilization Group |
Primary outcome
Time to start flatus
Time frame: 1 year
3 secondary outcomes
Rate of Complications
Time frame: 1 year
Length of stay
Time frame: 1 year
Rate of Mortality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Background: PubMed 30707226Daskivich 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.
- Background: PubMed 3558716Charlson 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.
- Background: PubMed 24422666Heron 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 publication: PubMed 32459426Ganer 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.
- Individual participant dataSharing planned: No. If requested, individual participant data (IPD) will be shared via e-mail after the reason has been evaluated.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilization recommendations in people with Ambulation Difficulty and Physical Examination, run by Ankara University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kamil Erozkan, Fellow (+905366154532, kamilerozkan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to start flatus (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05598294, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.