Spine FusionNCT06102681
Examination of the Effect of Early Mobilization on Postoperative Recovery, Pain, Quality of Life and Complication Development in Elective Minimally Invasive Spine Surgery
A study testing intervention group in people with Spine Fusion and Lumbar Disc Herniation, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
Accelerated Postoperative Recovery (ERAS) is a multidisciplinary approach aimed at facilitating faster and more effective recovery for patients undergoing surgical procedures. The ERAS protocol encompasses specific measures implemented during the preoperative, intraoperative, and postoperative phases. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spine Fusion, Lumbar Disc Herniation, Cervical Disc Disease
- What is being tested?
- intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Nov 2023to 15 Sep 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective minimal invasive spinal surgery patients
Who cannot join
- patients who is under 18 and over 65
- patients who have intubation tupe
- patients have mental disorders
- patients who underwent emergency surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duzce University Faculty of Health Science
Düzce, 81000
About this study
Accelerated Postoperative Recovery (ERAS) is a multidisciplinary approach aimed at facilitating faster and more effective recovery for patients undergoing surgical procedures. The ERAS protocol encompasses specific measures implemented during the preoperative, intraoperative, and postoperative phases. Its goal is to enable patients to achieve better outcomes by reducing postoperative pain, complications, and hospital stays. The multimodal and multidisciplinary approach to patient care during the perioperative period includes a combination of evidence-based interventions designed to reduce the stress of surgery to maintain anabolic homeostasis and promote recovery.
This approach involves preparing patients for surgery through assessment and education, optimizing intraoperative management (such as minimally invasive surgery, pain control, and optimal fluid management), and expediting postoperative recovery (e.g., through early feeding and mobilization). Early mobilization is considered a crucial element of this approach and is strongly recommended as part of ERAS guidelines across various surgical disciplines.
Prolonged bed rest following surgical treatment has been associated with adverse outcomes, such as thromboembolism, pneumonia, muscle weakness, and loss of physical conditioning. If a patient does not have physical limitations in the postoperative period, early ambulation benefits in the preservation of respiratory, circulatory, musculoskeletal, and gastrointestinal system functions, as well as in reducing complications related to anesthesia and surgery. Ultimately, it accelerates recovery, enables early discharge, reduces hospital costs, and lightens the workload of healthcare professionals.
Read the detailed description
Postoperative Accelerated Recovery (ERAS) is a multidisciplinary approach aimed at facilitating the faster and more effective recovery of patients undergoing surgical operations. The ERAS protocol encompasses specific measures implemented during the preoperative, intraoperative, and postoperative periods. Its objective is to ensure better outcomes for patients by reducing postoperative pain, complications, and the duration of hospital stays. The multimodal and multidisciplinary approach to patient care during the perioperative period includes a combination of evidence-based interventions aimed at reducing the stress of surgery to maintain anabolic homeostasis and promote recovery.
This includes preparing the patient for surgery through assessment and education, ensuring the best possible management during surgery (such as minimally invasive surgery, pain control, and optimal fluid management), and expediting postoperative recovery (for example, through early feeding and mobilization). Early mobilization is considered one of the most crucial elements of this approach and is strongly recommended as part of ERAS guidelines in many surgical disciplines.
Prolonged post-surgical bed rest has been associated with adverse outcomes such as thromboembolism, pneumonia, reduced muscle strength, and physical conditioning loss. If a patient does not have physical limitations in the postoperative period, early mobilization is beneficial in preserving respiratory, circulatory, musculoskeletal, and gastrointestinal system functions and in reducing complications related to anesthesia and surgery. Ultimately, it accelerates recovery, enables early discharge, and reduces hospital costs and the workload of healthcare professionals.
Despite the well-recognized importance of early mobilization in surgical procedures, it has been reported that compliance with mobilization goals is low, and those unable to achieve early postoperative mobilization are at a higher risk of complications. Reviewing the literature, it is observed that patients undergoing spinal surgery tend to avoid movement during the postoperative period due to experiencing intense pain before the surgery.
In this context, the aim of this study is to examine the impact of postoperative mobilization timing on patients' recovery status, pain levels, quality of life, and the development of complications following spinal surgery. The results obtained from the study are intended to be reported, thus contributing to the literature in this field and serving as a resource for future studies in this area.
- Conditions
- Spine Fusion, Lumbar Disc Herniation, Cervical Disc Disease
- Being tested
- intervention group
- Keywords
- quality of life, pain, minimal invasive surgery, ambulation, ERAS, recovery
- Medical subject headings
- Intervertebral Disc Displacement, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention groupOther
we will measure, consider and compare patients pain level, quality of life and recovery process. For these aims we will use numeric pain scale, nottingham health profile and postoperative recovery index.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Patients who are in the control group will receive standard clinical care and these patient will be stand up 1. day after operation. |
| experimental group | Experimental | Patients who are in the experimental group will receive standard clinical care and they will stand up 8. hours after operation. Receives: Other: intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
we will use to measure patient pain level Numeric Pain Scale (NPS) several times. The intensity of pain will measure the area in which the individual mark between 0 (no pain) and 10 (worst pain i felt in my life).
Measured: before operation and after 10 days operation
Secondary outcomes (2)
Life Quality
we will use to measure quality of life of patients with Nottingham Health Profile. Thanks to survey we will compare to both group quality of life level. the survey is consist of six sub-dimention and thirty-eight item. the survey will use two times, first one will measure after first ambulation and the second one will measure after 10 days later.
Measured: before operation and after 10 days operation
recovery process
we will use to measure post operative recovery index to me for patients recovery process. the questionnaire is consist of 5 sub-dimention and 25 item. the survey will use two times, first one will measure after first ambulation and the second one will measure after 10 days later.
Measured: before operation and after 10 days operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start27 Nov 2023
- Primary completion6 May 2024
- Study completion15 Sep 2024 (estimated)
Why it stopped: because of less patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine FusionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- all participants will assigned to two grup. one grup will be intervention the other will be control.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102681
- Sponsor's protocol ID
- AtiyeErbas
- Status last verified
- Oct 2023
- First submitted
- 21 Oct 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Effect of Early Mobilization on Postoperative Recovery, Pain, Quality of Life and Complication Development in Elective Minimally Invasive Spine Surgery
- ClinicalTrials.gov ID
- NCT06102681
- Acronym / sponsor ID
- AtiyeErbas
- Conditions
- Spine Fusion, Lumbar Disc Herniation, Cervical Disc Disease
- Keywords
- quality of life, pain, minimal invasive surgery, ambulation, ERAS, recovery
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: because of less patient
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 26 Oct 2023 (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.
Accelerated Postoperative Recovery (ERAS) is a multidisciplinary approach aimed at facilitating faster and more effective recovery for patients undergoing surgical procedures. The ERAS protocol encompasses specific measures implemented during the preoperative, intraoperative, and postoperative phases. Its goal is to enable patients to achieve better outcomes by reducing postoperative pain, complications, and hospital stays. The multimodal and multidisciplinary approach to patient care during the perioperative period includes a combination of evidence-based interventions designed to reduce the stress of surgery to maintain anabolic homeostasis and promote recovery.
This approach involves preparing patients for surgery through assessment and education, optimizing intraoperative management (such as minimally invasive surgery, pain control, and optimal fluid management), and expediting postoperative recovery (e.g., through early feeding and mobilization). Early mobilization is considered a crucial element of this approach and is strongly recommended as part of ERAS guidelines across various surgical disciplines.
Prolonged bed rest following surgical treatment has been associated with adverse outcomes, such as thromboembolism, pneumonia, muscle weakness, and loss of physical conditioning. If a patient does not have physical limitations in the postoperative period, early ambulation benefits in the preservation of respiratory, circulatory, musculoskeletal, and gastrointestinal system functions, as well as in reducing complications related to anesthesia and surgery. Ultimately, it accelerates recovery, enables early discharge, reduces hospital costs, and lightens the workload of healthcare professionals.
Detailed description
Postoperative Accelerated Recovery (ERAS) is a multidisciplinary approach aimed at facilitating the faster and more effective recovery of patients undergoing surgical operations. The ERAS protocol encompasses specific measures implemented during the preoperative, intraoperative, and postoperative periods. Its objective is to ensure better outcomes for patients by reducing postoperative pain, complications, and the duration of hospital stays. The multimodal and multidisciplinary approach to patient care during the perioperative period includes a combination of evidence-based interventions aimed at reducing the stress of surgery to maintain anabolic homeostasis and promote recovery.
This includes preparing the patient for surgery through assessment and education, ensuring the best possible management during surgery (such as minimally invasive surgery, pain control, and optimal fluid management), and expediting postoperative recovery (for example, through early feeding and mobilization). Early mobilization is considered one of the most crucial elements of this approach and is strongly recommended as part of ERAS guidelines in many surgical disciplines.
Prolonged post-surgical bed rest has been associated with adverse outcomes such as thromboembolism, pneumonia, reduced muscle strength, and physical conditioning loss. If a patient does not have physical limitations in the postoperative period, early mobilization is beneficial in preserving respiratory, circulatory, musculoskeletal, and gastrointestinal system functions and in reducing complications related to anesthesia and surgery. Ultimately, it accelerates recovery, enables early discharge, and reduces hospital costs and the workload of healthcare professionals.
Despite the well-recognized importance of early mobilization in surgical procedures, it has been reported that compliance with mobilization goals is low, and those unable to achieve early postoperative mobilization are at a higher risk of complications. Reviewing the literature, it is observed that patients undergoing spinal surgery tend to avoid movement during the postoperative period due to experiencing intense pain before the surgery.
In this context, the aim of this study is to examine the impact of postoperative mobilization timing on patients' recovery status, pain levels, quality of life, and the development of complications following spinal surgery. The results obtained from the study are intended to be reported, thus contributing to the literature in this field and serving as a resource for future studies in this area.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- all participants will assigned to two grup. one grup will be intervention the other will be control.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Patients who are in the control group will receive standard clinical care and these patient will be stand up 1. day after operation. |
| experimental group | Experimental | Other: intervention groupPatients who are in the experimental group will receive standard clinical care and they will stand up 8. hours after operation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective minimal invasive spinal surgery patients
Key exclusion criteria (4 listed)
- patients who is under 18 and over 65
- patients who have intubation tupe
- patients have mental disorders
- patients who underwent emergency surgery
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 |
|---|---|---|
| intervention groupwe will measure, consider and compare patients pain level, quality of life and recovery process. For these aims we will use numeric pain scale, nottingham health profile and postoperative recovery index. | Other | experimental group |
Primary outcome
Pain level
Time frame: before operation and after 10 days operation
we will use to measure patient pain level Numeric Pain Scale (NPS) several times. The intensity of pain will measure the area in which the individual mark between 0 (no pain) and 10 (worst pain i felt in my life).
2 secondary outcomes
Life Quality
Time frame: before operation and after 10 days operation
recovery process
Time frame: before operation and after 10 days operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention group in people with Spine Fusion and Lumbar Disc Herniation, run by Duzce 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 1 inclusion and 4 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: paused, as of the sponsor's last update on 9 Aug 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?
Results are not available in the source record.
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?
Pain level (time frame: before operation and after 10 days operation). 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 9 Aug 2024.