Total Knee ArthroplastyNCT07336160
ERAS-Based Preoperative Nutrition and Fasting in Total Knee Arthroplasty
A study testing ERAS-Based Preoperative Nutrition Education and Fasting Protocol and Standard Preoperative Care in people with Total Knee Arthroplasty and Postoperative Nausea and Vomiting, run by Nermin Ocaktan at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled study is to investigate the effect of implementing a preoperative nutrition education and fasting protocol prepared in accordance with Enhanced Recovery After Surgery (ERAS) guidelines during the 24-hour preoperative period on postoperative hydration status and the incidence of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Postoperative Nausea and Vomiting
- What is being tested?
- ERAS-Based Preoperative Nutrition Education and Fasting Protocol and Standard Preoperative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Dec 2025to 1 Sep 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older.
- Patients scheduled for elective total knee arthroplasty.
- Patients expected to be hospitalized for at least 48 hours postoperatively.
- Ability to communicate verbally and provide informed consent.
- Patients with adequate cognitive and neurological capacity to understand study procedures.
Who cannot join
- Presence of any chronic disease requiring fluid restriction.
- Diagnosed cognitive impairment or psychiatric disorders affecting comprehension (e.g., Alzheimer's disease, dementia, psychotic disorders).
- Acute conditions causing dehydration in the preoperative period (e.g., vomiting, diarrhea, excessive fluid loss).
- Intraoperative complications requiring intensive care unit admission.
- Postoperative follow-up shorter than 48 hours due to early discharge or transfer to another clinic.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acıbadem Health Group Atakent Hospital
Istanbul, Istanbul, 34752
Nermin Ocaktan, PhD, 05337373306, nermin.ocaktan@acibadem.edu.tr
About this study
Official title: Effect of ERAS-Based Preoperative Nutrition Education and Fasting Protocol on Postoperative Hydration Status and Nausea-Vomiting in Patients Undergoing Total Knee Arthroplasty
The aim of this randomized controlled study is to investigate the effect of implementing a preoperative nutrition education and fasting protocol prepared in accordance with Enhanced Recovery After Surgery (ERAS) guidelines during the 24-hour preoperative period on postoperative hydration status and the incidence of nausea and vomiting in patients scheduled for total knee arthroplasty.
Total knee arthroplasty is a commonly performed surgical procedure, particularly in older adults, and postoperative recovery may be negatively affected by surgical stress, anesthesia-related complications, dehydration, and postoperative nausea and vomiting. ERAS protocols emphasize the optimization of preoperative nutrition and hydration as key components to improve postoperative outcomes.
Read more
In this study, patients undergoing elective total knee arthroplasty will be randomly assigned to an intervention group or a control group. Patients in the intervention group will receive ERAS-based preoperative nutrition education and a standardized fasting protocol during the 24 hours prior to surgery, while patients in the control group will receive routine standard care.
Postoperative hydration status, nausea and vomiting severity, and fluid intake-output balance will be assessed and compared between the two groups. The findings of this study are expected to contribute to improving perioperative nursing care practices and enhancing patient recovery and comfort following total knee arthroplasty.
Read the detailed description
This randomized controlled trial is designed to evaluate the effect of ERAS protocol-based preoperative nutrition education and fasting management on postoperative hydration status and nausea-vomiting outcomes in patients undergoing elective total knee arthroplasty.
Total knee arthroplasty is an effective and frequently performed surgical intervention, particularly among older adults with degenerative joint disease. However, perioperative stress, prolonged fasting, and anesthesia-related factors may adversely affect postoperative recovery, leading to dehydration, nausea, and vomiting. Optimizing perioperative care through evidence-based ERAS protocols is therefore essential to improve patient outcomes.
ERAS protocols promote a multidisciplinary approach aimed at reducing surgical stress and accelerating postoperative recovery. One of the core components of ERAS is the optimization of preoperative nutrition and hydration. According to evidence-based guidelines, solid foods may be consumed up to 6 hours and clear liquids up to 2 hours prior to elective surgery. This approach reduces unnecessary prolonged fasting, prevents dehydration and insulin resistance, and improves postoperative comfort without increasing anesthesia-related risks.
The study will be conducted in the orthopedic clinic of Acıbadem Altunizade Hospital. Eligible patients scheduled for elective total knee arthroplasty will be recruited and randomly assigned to either the intervention or control group using a simple randomization method. Written informed consent will be obtained from all participants prior to enrollment.
Patients in the intervention group will receive an ERAS-based preoperative nutrition education leaflet and will be instructed to follow the standardized nutrition and fasting protocol during the 24-hour preoperative period. Patients in the control group will receive routine standard preoperative care as applied in the clinic.
Data collection will include demographic and clinical characteristics, postoperative hydration status, nausea and vomiting frequency and severity, and fluid intake-output monitoring. The following validated instruments will be used: the Surgical Thirst Discomfort Scale, the Rhodes Index of Nausea, Vomiting and Retching, a numeric nausea rating scale, and fluid balance monitoring forms.
Postoperative outcomes will be assessed for both groups, including hydration status, nausea and vomiting incidence, and fluid intake-output balance. Statistical analyses will be performed using SPSS software. Appropriate parametric or non-parametric tests will be applied based on data distribution, with a significance level set at p < 0.05.
This study aims to provide evidence on the effectiveness of ERAS-based preoperative nutrition education and fasting protocols in improving postoperative hydration and reducing nausea and vomiting, thereby supporting the development of structured, evidence-based nursing interventions in perioperative care.
- Being tested
- ERAS-Based Preoperative Nutrition Education and Fasting Protocol, Standard Preoperative Care
- Keywords
- Enhanced Recovery After Surgery, ERAS Protocol, Preoperative Nutrition, Fasting Protocol, Total Knee Replacement, Postoperative Hydration, Nausea and Vomiting, Perioperative Nursing Care
- Medical subject headings
- Postoperative Nausea and Vomiting, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS-Based Preoperative Nutrition Education and Fasting ProtocolBehavioural
A structured preoperative nutrition education program and evidence-based fasting protocol developed in accordance with ERAS guidelines, implemented during the 24 hours prior to total knee arthroplasty.
Standard Preoperative CareOther
Participants receive routine preoperative care according to standard institutional clinical practice without ERAS-based nutrition education or fasting protocol.
| Study group | Role | What they receive |
|---|---|---|
| ERAS-Based Preoperative Nutrition and Fasting Protocol Group | Experimental | Participants receive ERAS-based preoperative nutrition education and an evidence-based fasting protocol during the 24 hours before total knee arthroplasty. Receives: Behavioral: ERAS-Based Preoperative Nutrition Education and Fasting Protocol |
| Standard Care Group | Active comparator | Participants receive routine preoperative care according to standard clinical practice without ERAS-based nutrition education or fasting protocol. Receives: Other: Standard Preoperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Thirst Discomfort
Postoperative thirst discomfort assessed using the Surgical Thirst Discomfort Scale. The scale includes 6 items (dry mouth, dry lips, thick saliva, dry throat, bad taste in the mouth, desire to drink water), each rated from 0 to 2 (0 = not uncomfortable, 1 = slightly uncomfortable, 2 = very uncomfortable). Total score range: 0-12. Higher scores indicate greater thirst-related discomfort (worse outcome).
Measured: Within the first 48 hours after surgery
Postoperative Fluid Balance
Postoperative hydration status assessed by fluid intake-output balance records.
Measured: Within the first 48 hours after surgery
Secondary outcomes (3)
Postoperative Nausea and Vomiting Severity
Severity of postoperative nausea and vomiting assessed using the Rhodes Index of Nausea, Vomiting, and Retching (RINVR). The RINVR is an 8-item patient-reported scale. Each item is scored from 0 (no distress) to 4 (maximum distress), yielding a total score range of 0-32. Higher total scores indicate greater nausea/vomiting severity and distress (worse outcome).
Measured: Within the first 48 hours after surgery
Postoperative Nausea Intensity
Intensity of postoperative nausea assessed using the Numeric Nausea Rating Scale (NNRS). Participants rate their current nausea severity on a numeric scale from 0 to 10, where 0 indicates no nausea and 10 indicates the most severe nausea. Higher scores indicate greater nausea intensity (worse outcome).
Measured: Within the first 48 hours after surgery
Perioperative Fluid Balance
Perioperative fluid balance assessed as net fluid balance, calculated by subtracting total fluid output from total fluid intake using intake-output records.
Measured: From preoperative period to 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start26 Dec 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two parallel groups: an intervention group receiving ERAS-based preoperative nutrition education and fasting protocol, and a control group receiving standard care. Outcomes will be assessed preoperatively and postoperatively.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nermin Ocaktan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nermin Ocaktan, Acibadem University
- Investigators
- Nermin Ocaktan, PhD, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336160
- Sponsor's protocol ID
- 2025-12/474
- Status last verified
- Jan 2026
- First submitted
- 26 Dec 2025
- Last updated
- 14 Jan 2026
- 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 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of ERAS-Based Preoperative Nutrition Education and Fasting Protocol on Postoperative Hydration Status and Nausea-Vomiting in Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07336160
- Acronym / sponsor ID
- 2025-12/474
- Keywords
- Enhanced Recovery After Surgery, ERAS Protocol, Preoperative Nutrition, Fasting Protocol, Total Knee Replacement, Postoperative Hydration, Nausea and Vomiting, Perioperative Nursing Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Nermin OcaktanUniversity, hospital or other
- Study start
- 26 Dec 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 13 Jan 2026 (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 aim of this randomized controlled study is to investigate the effect of implementing a preoperative nutrition education and fasting protocol prepared in accordance with Enhanced Recovery After Surgery (ERAS) guidelines during the 24-hour preoperative period on postoperative hydration status and the incidence of nausea and vomiting in patients scheduled for total knee arthroplasty.
Total knee arthroplasty is a commonly performed surgical procedure, particularly in older adults, and postoperative recovery may be negatively affected by surgical stress, anesthesia-related complications, dehydration, and postoperative nausea and vomiting. ERAS protocols emphasize the optimization of preoperative nutrition and hydration as key components to improve postoperative outcomes.
In this study, patients undergoing elective total knee arthroplasty will be randomly assigned to an intervention group or a control group. Patients in the intervention group will receive ERAS-based preoperative nutrition education and a standardized fasting protocol during the 24 hours prior to surgery, while patients in the control group will receive routine standard care.
Postoperative hydration status, nausea and vomiting severity, and fluid intake-output balance will be assessed and compared between the two groups. The findings of this study are expected to contribute to improving perioperative nursing care practices and enhancing patient recovery and comfort following total knee arthroplasty.
Detailed description
This randomized controlled trial is designed to evaluate the effect of ERAS protocol-based preoperative nutrition education and fasting management on postoperative hydration status and nausea-vomiting outcomes in patients undergoing elective total knee arthroplasty.
Total knee arthroplasty is an effective and frequently performed surgical intervention, particularly among older adults with degenerative joint disease. However, perioperative stress, prolonged fasting, and anesthesia-related factors may adversely affect postoperative recovery, leading to dehydration, nausea, and vomiting. Optimizing perioperative care through evidence-based ERAS protocols is therefore essential to improve patient outcomes.
ERAS protocols promote a multidisciplinary approach aimed at reducing surgical stress and accelerating postoperative recovery. One of the core components of ERAS is the optimization of preoperative nutrition and hydration. According to evidence-based guidelines, solid foods may be consumed up to 6 hours and clear liquids up to 2 hours prior to elective surgery. This approach reduces unnecessary prolonged fasting, prevents dehydration and insulin resistance, and improves postoperative comfort without increasing anesthesia-related risks.
The study will be conducted in the orthopedic clinic of Acıbadem Altunizade Hospital. Eligible patients scheduled for elective total knee arthroplasty will be recruited and randomly assigned to either the intervention or control group using a simple randomization method. Written informed consent will be obtained from all participants prior to enrollment.
Patients in the intervention group will receive an ERAS-based preoperative nutrition education leaflet and will be instructed to follow the standardized nutrition and fasting protocol during the 24-hour preoperative period. Patients in the control group will receive routine standard preoperative care as applied in the clinic.
Data collection will include demographic and clinical characteristics, postoperative hydration status, nausea and vomiting frequency and severity, and fluid intake-output monitoring. The following validated instruments will be used: the Surgical Thirst Discomfort Scale, the Rhodes Index of Nausea, Vomiting and Retching, a numeric nausea rating scale, and fluid balance monitoring forms.
Postoperative outcomes will be assessed for both groups, including hydration status, nausea and vomiting incidence, and fluid intake-output balance. Statistical analyses will be performed using SPSS software. Appropriate parametric or non-parametric tests will be applied based on data distribution, with a significance level set at p < 0.05.
This study aims to provide evidence on the effectiveness of ERAS-based preoperative nutrition education and fasting protocols in improving postoperative hydration and reducing nausea and vomiting, thereby supporting the development of structured, evidence-based nursing interventions in perioperative care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel groups: an intervention group receiving ERAS-based preoperative nutrition education and fasting protocol, and a control group receiving standard care. Outcomes will be assessed preoperatively and postoperatively.
| Arm | Type | Receives |
|---|---|---|
| ERAS-Based Preoperative Nutrition and Fasting Protocol Group | Experimental | Behavioral: ERAS-Based Preoperative Nutrition Education and Fasting ProtocolParticipants receive ERAS-based preoperative nutrition education and an evidence-based fasting protocol during the 24 hours before total knee arthroplasty. |
| Standard Care Group | Active comparator | Other: Standard Preoperative CareParticipants receive routine preoperative care according to standard clinical practice without ERAS-based nutrition education or fasting protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years and older.
- Patients scheduled for elective total knee arthroplasty.
- Patients expected to be hospitalized for at least 48 hours postoperatively.
- Ability to communicate verbally and provide informed consent.
- Patients with adequate cognitive and neurological capacity to understand study procedures.
Key exclusion criteria (5 listed)
- Presence of any chronic disease requiring fluid restriction.
- Diagnosed cognitive impairment or psychiatric disorders affecting comprehension (e.g., Alzheimer's disease, dementia, psychotic disorders).
- Acute conditions causing dehydration in the preoperative period (e.g., vomiting, diarrhea, excessive fluid loss).
- Intraoperative complications requiring intensive care unit admission.
- Postoperative follow-up shorter than 48 hours due to early discharge or transfer to another clinic.
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 |
|---|---|---|
| ERAS-Based Preoperative Nutrition Education and Fasting ProtocolA structured preoperative nutrition education program and evidence-based fasting protocol developed in accordance with ERAS guidelines, implemented during the 24 hours prior to total knee arthroplasty. | Behavioural | ERAS-Based Preoperative Nutrition and Fasting Protocol Group |
| Standard Preoperative CareParticipants receive routine preoperative care according to standard institutional clinical practice without ERAS-based nutrition education or fasting protocol. | Other | Standard Care Group |
Primary outcome
Postoperative Thirst Discomfort
Time frame: Within the first 48 hours after surgery
Postoperative thirst discomfort assessed using the Surgical Thirst Discomfort Scale. The scale includes 6 items (dry mouth, dry lips, thick saliva, dry throat, bad taste in the mouth, desire to drink water), each rated from 0 to 2 (0 = not uncomfortable, 1 = slightly uncomfortable, 2 = very uncomfortable). Total score range: 0-12. Higher scores indicate greater thirst-related discomfort (worse outcome).
Postoperative Fluid Balance
Time frame: Within the first 48 hours after surgery
Postoperative hydration status assessed by fluid intake-output balance records.
3 secondary outcomes
Postoperative Nausea and Vomiting Severity
Time frame: Within the first 48 hours after surgery
Postoperative Nausea Intensity
Time frame: Within the first 48 hours after surgery
Perioperative Fluid Balance
Time frame: From preoperative period to 48 hours postoperatively
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 14 Jan 2026.
- 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.
Nermin Ocaktan, PhD principal investigator
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS-Based Preoperative Nutrition Education and Fasting Protocol and Standard Preoperative Care in people with Total Knee Arthroplasty and Postoperative Nausea and Vomiting, run by Nermin Ocaktan 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 14 Jan 2026. 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?
Contact Nermin Ocaktan, PhD (+905337373306, nermin.ocaktan@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Thirst Discomfort (time frame: Within the first 48 hours after surgery). The study lists 2 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 14 Jan 2026.