Gastrointestinal DiseasesNCT06679478
Evaluation of Early Mobilization Protocol in Patients Undergoing Gastrointestinal Surgery
A study testing Enhanced Recovery After Surgery (ERAS) Early Mobilization Protocol in people with Gastrointestinal Diseases, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators aimed to evaluate the early mobilization protocol created in accordance with the accelerated recovery guide after surgery in patients undergoing gastrointestinal surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Diseases
- What is being tested?
- Enhanced Recovery After Surgery (ERAS) Early Mobilization Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2024to 9 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years of age or older
- Agreeing to participate in the study
- Being able to understand, speak Turkish or have no obstacle to communication
- Having undergone open gastrointestinal surgery
- Having an American Society of Anesthesiologists (ASA) score <IV
- Being fully independent according to the Modified Barthel Index during the pre-operative period
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- Staying in the hospital for at least 48 hours after the surgery
- Having a phone
- Agreeing to download the 'StepsApp Pedometer' application to their phone
- Agreeing to carry the phone with them during the post-operative mobilization processes
Who cannot join
- Being taken into emergency surgery
- Having had major gastrointestinal surgery before
- Having a diagnosis that may restrict mobilization (neurological, cardiovascular, respiratory and musculoskeletal comorbidities)
- High risk of falling in the preoperative period
- Using medication that may affect mobilization
- Having a diagnosis of any psychiatric disease
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- Having a Nutritional Risk Score score of ≥3
- Being in contact isolation
- Being morbidly obese
- Being in intensive care for more than 24 hours during the postoperative period
- Having an intubation period of more than 24 hours during the postoperative period
- Developing a complication that may prevent mobilization after surgery
- Withdrawing from participating in the study,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Early Mobilization Protocol Established in Accordance With Enhanced Recovery After Surgery Guidelines in Patients Undergoing Gastrointestinal Surgery
In this study, the investigators aimed to evaluate the early mobilization protocol created in accordance with the accelerated recovery guide after surgery in patients undergoing gastrointestinal surgery.
Read the detailed description
This study is an experimental study. The participants in the control group are applied to the mobilization applied in routine clinics. The participants in the intervention group are applied to the mobilization protocol created in accordance with the Enhanced Recovery After Surgery (ERAS) guidelines. It is planned to evaluate the postoperative mobilization process of both groups.
In this study, the researchers aimed to evaluate the early mobilization protocol created in accordance with the accelerated recovery guide after surgery in patients undergoing gastrointestinal surgery.
- Conditions
- Gastrointestinal Diseases
- Being tested
- Enhanced Recovery After Surgery (ERAS) Early Mobilization Protocol
- Keywords
- Gastrointestinal Diseases, Enhanced Recovery After Surgery, Early Ambulation
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After Surgery (ERAS) Early Mobilization ProtocolProcedure or surgery
Also called Early Mobilization Protocol
The intervention is applied from the first day after surgery until discharge. (including the day of discharge).
| Study group | Role | What they receive |
|---|---|---|
| Mobilization Performed in Routine Clinic Group | No intervention | Participants undergoing gastrointestinal surgery will receive routine clinic mobilization. The investigator will not perform any interventions. |
| Early Mobilization Protocol Created in Enhanced Recovery After Surgery (ERAS) Guidelines Group | Experimental | Participants undergoing gastrointestinal surgery will watch a video 1 day before surgery that includes information about the importance of mobilization and the process.
The participant will be applied a mobilization protocol created in line with the postoperative mobilization eras (enhanced recovery after surgery) guidelines. Receives: Procedure: Enhanced Recovery After Surgery (ERAS) Early Mobilization Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of the ERAS (Enhanced Recovery After Surgery) early mobilization protocol on the number of steps taken daily after surgery
The number of steps taken by the participant daily after surgery will be measured via a phone pedometer application (StepsApp).
Measured: From admission to discharge, up to 1 week
The effect of the ERAS (Enhanced Recovery After Surgery) early mobilization protocol on the distance moved after surgery
The daily distance moved by the participant after surgery will be measured via a phone pedometer application (StepsApp).
Measured: From admission to discharge, up to 1 week
The effect of the ERAS early mobilization protocol on the recovery of the gastrointestinal system after surgery
The researcher will record the day the participant first passed gas after surgery and the date of his/her first defecation.
Measured: From admission to discharge, up to 1 week
The effect of the ERAS (Enhanced Recovery After Surgery) early mobilization protocol on the level of ability to perform daily living activities after surgery
The researcher makes the measurement with the Modified Barthel Index scale. Modified Barthel Index: The highest score is 100, the lowest score is 0. The patient is stated as fully dependent in the range of 0-20 points, highly dependent in the range of 21-61 points, moderately dependent in the range of 62-90 points, slightly dependent in the range of 91-99 points, and fully independent in the range of 100 points. Daily evaluations are made until discharge after surgery.
Measured: (From admission to discharge, up to 1 week) and (When he comes for a check-up 1 week after discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start11 Nov 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion9 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The participants in the control group are given the mobilization applied in routine clinics. The participants in the intervention group are given the mobilization protocol created in accordance with the enhanced recovery after surgery guidelines.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Şayır Koksal, Uludag University
- Investigators
- Derya Şayır Köksal, Lecturer, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679478
- Sponsor's protocol ID
- UludagU-SBF-DSK-01
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Early Mobilization Protocol Established in Accordance With Enhanced Recovery After Surgery Guidelines in Patients Undergoing Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT06679478
- Acronym / sponsor ID
- UludagU-SBF-DSK-01
- Conditions
- Gastrointestinal Diseases
- Keywords
- Gastrointestinal Diseases, Enhanced Recovery After Surgery, Early Ambulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 9 Nov 2025 (estimated)
- First posted
- 7 Nov 2024 (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.
In this study, the investigators aimed to evaluate the early mobilization protocol created in accordance with the accelerated recovery guide after surgery in patients undergoing gastrointestinal surgery.
Detailed description
This study is an experimental study. The participants in the control group are applied to the mobilization applied in routine clinics. The participants in the intervention group are applied to the mobilization protocol created in accordance with the Enhanced Recovery After Surgery (ERAS) guidelines. It is planned to evaluate the postoperative mobilization process of both groups.
In this study, the researchers aimed to evaluate the early mobilization protocol created in accordance with the accelerated recovery guide after surgery in patients undergoing gastrointestinal surgery.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The participants in the control group are given the mobilization applied in routine clinics. The participants in the intervention group are given the mobilization protocol created in accordance with the enhanced recovery after surgery guidelines.
| Arm | Type | Receives |
|---|---|---|
| Mobilization Performed in Routine Clinic Group | No intervention | –Participants undergoing gastrointestinal surgery will receive routine clinic mobilization. The investigator will not perform any interventions. |
| Early Mobilization Protocol Created in Enhanced Recovery After Surgery (ERAS) Guidelines Group | Experimental | Procedure: Enhanced Recovery After Surgery (ERAS) Early Mobilization ProtocolParticipants undergoing gastrointestinal surgery will watch a video 1 day before surgery that includes information about the importance of mobilization and the process. The participant will be applied a mobilization protocol created in line with the postoperative mobilization eras (enhanced recovery after surgery) guidelines. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Being 18 years of age or older
- Agreeing to participate in the study
- Being able to understand, speak Turkish or have no obstacle to communication
- Having undergone open gastrointestinal surgery
- Having an American Society of Anesthesiologists (ASA) score <IV
Key exclusion criteria (13 listed)
- Being taken into emergency surgery
- Having had major gastrointestinal surgery before
- Having a diagnosis that may restrict mobilization (neurological, cardiovascular, respiratory and musculoskeletal comorbidities)
- High risk of falling in the preoperative period
- Using medication that may affect mobilization
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 |
|---|---|---|
| Enhanced Recovery After Surgery (ERAS) Early Mobilization ProtocolAlso: Early Mobilization ProtocolThe intervention is applied from the first day after surgery until discharge. (including the day of discharge). | Procedure or surgery | Early Mobilization Protocol Created in Enhanced Recovery After Surgery (ERAS) Guidelines Group |
Primary outcome
The effect of the ERAS (Enhanced Recovery After Surgery) early mobilization protocol on the number of steps taken daily after surgery
Time frame: From admission to discharge, up to 1 week
The number of steps taken by the participant daily after surgery will be measured via a phone pedometer application (StepsApp).
The effect of the ERAS (Enhanced Recovery After Surgery) early mobilization protocol on the distance moved after surgery
Time frame: From admission to discharge, up to 1 week
The daily distance moved by the participant after surgery will be measured via a phone pedometer application (StepsApp).
The effect of the ERAS early mobilization protocol on the recovery of the gastrointestinal system after surgery
Time frame: From admission to discharge, up to 1 week
The researcher will record the day the participant first passed gas after surgery and the date of his/her first defecation.
The effect of the ERAS (Enhanced Recovery After Surgery) early mobilization protocol on the level of ability to perform daily living activities after surgery
Time frame: (From admission to discharge, up to 1 week) and (When he comes for a check-up 1 week after discharge)
The researcher makes the measurement with the Modified Barthel Index scale. Modified Barthel Index: The highest score is 100, the lowest score is 0. The patient is stated as fully dependent in the range of 0-20 points, highly dependent in the range of 21-61 points, moderately dependent in the range of 62-90 points, slightly dependent in the range of 91-99 points, and fully independent in the range of 100 points. Daily evaluations are made until discharge after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Derya Şayır Köksal, Lecturer principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Recovery After Surgery (ERAS) Early Mobilization Protocol in people with Gastrointestinal Diseases, run by Uludag University at 1 site 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 10 inclusion and 13 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: enrolling by invitation, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of the ERAS (Enhanced Recovery After Surgery) early mobilization protocol on the number of steps taken daily after surgery (time frame: From admission to discharge, up to 1 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2024.