Postoperative OutcomesNCT06989229
The Effect of Perioperative Nutritional Care on Recovery After Knee and Hip Replacement Surgery
An observational study of Postoperative Outcomes and Postoperative Complications, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
Trial summary
This prospective observational study will assess the impact of standardized perioperative nutritional care on postoperative outcomes in patients undergoing elective total hip (THA) or knee arthroplasty (TKA) at the First Department of Orthopaedic Surgery, St. Anne's University Hospital in Brno. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Outcomes, Postoperative Complications, Length of Hospital Stay
- How many people
- 1,000 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2025to 31 Dec 2027
- Phase
- Observational
- 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
Study population: Patients to undergo elective total hip and knee arthroplasty
Who may be able to join
- Elective total hip replacement Elective total knee replacement
Who cannot join
- Hip fracture Diabetes mellitus 1 Insulinotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
First Department of Orthopaedic Surgery, St. Anne's University Hospital and Faculty of Medicine, Masaryk University, Brno, Czechia
Brno, Czechia, 60200
Vasileios Apostolopoulos, 722101065, Vasilis.apo@email.cz
Tomáš Tomáš, Assoc.Prof., M.D., Ph.D.
About this study
Official title: Prospective Study on the Impact of Perioperative Nutritional Care in Patients Undergoing Total Knee and Hip Arthroplasty on Postoperative Outcomes
This prospective observational study will assess the impact of standardized perioperative nutritional care on postoperative outcomes in patients undergoing elective total hip (THA) or knee arthroplasty (TKA) at the First Department of Orthopaedic Surgery, St. Anne's University Hospital in Brno. The protocol includes preoperative patient education, nutritional risk screening, and carbohydrate loading up to two hours before anesthesia, followed by early postoperative refeeding.
Data collection will include demographic and surgical variables, nutritional status, carbohydrate intake, and the occurrence of intra- and postoperative complications, including infection and delayed wound healing.
As perioperative nutritional care is part of routine clinical practice, the study requires no additional interventions or resources. Results will provide evidence on the effectiveness of structured nutritional support in enhancing recovery and reducing complications after joint replacement surgery.
Read the detailed description
At the First Department of Orthopaedics of St. Anne's University Hospital in Brno, nutritional intervention is an established and integral part of care for patients undergoing total knee and hip arthroplasty. As part of long-term preoperative preparation, emphasis is placed on patient education and the optimization of their nutritional status even before hospital admission. Education on the importance of proper nutrition is provided through the Patient Academy, where preoperative nutritional risk is also assessed. In patients identified as being at nutritional risk, targeted efforts are made to improve their nutritional status.
Preoperative fasting is an outdated method of preparing for surgical stress and can negatively affect the overall recovery process. Therefore, our clinic focuses on eliminating fasting by using carbohydrate loading, allowing patients to consume a carbohydrate drink up to two hours before the induction of anesthesia. After surgery, early refeeding is consistently applied, which supports faster recovery and reduces the risk of complications.
The aim of this study is to investigate the impact of specialized perioperative nutritional care on postoperative outcomes, with the primary objective being to assess the occurrence of postoperative complications and the length of hospital stay. For this purpose, a wide range of clinical data will be collected and analyzed, including patient age, type of surgery, BMI (body mass index), preoperative nutritional risk, amount of carbohydrate drink consumed (including taste rating), occurrence of intraoperative complications-especially aspiration-and postoperative complications such as infections and wound healing issues, as well as length of hospitalization. Data will be securely stored in the REDCap (Research Electronic Data Capture) system.
The research project will be conducted at the 1st Department of Orthopaedics of St. Anne's University Hospital in Brno (sponsor), and will include all patients undergoing elective total hip (THA) or knee (TKA) arthroplasty for whom carbohydrate loading is indicated. The implementation of the study will not incur any additional costs, as preoperative nutritional care is already a standard and established part of routine care for patients undergoing elective joint replacements. The study will provide important insights into the effectiveness of specialized nutritional care in the perioperative period and its impact on overall postoperative outcomes.
Preoperative Fasting and Nutritional Preparation Preoperative fasting is considered an unsuitable approach to preparing for surgical stress. Therefore, international societies such as ESA - European Society of Anaesthesiology and Intensive Care, ERAS - Enhanced Recovery After Surgery and ESPEN - European Society for Clinical Nutrition and Metabolism recommend minimizing fasting periods to support improved postoperative recovery.
Oral Intake Before Surgery The final meal before surgery is dinner, including a late-night snack, which is part of the low-residue diet provided by the dietary system at St. Anne's University Hospital in Brno. On the day before surgery, patients are routinely prescribed a low-residue diet (Diet No. 5) with possible modifications (5MM, 5ML, 5BML, 0/5). Patients with diabetes mellitus or impaired glucose tolerance are prescribed a diabetic low-residue diet (Diet No. 9/5), with appropriate modifications (9/5MM, 9/5ML, 90/5). Diet orders are entered into the hospital information system (NIS-SP) no later than 14:00 on the day prior to surgery.
Carbohydrate Loading
Carbohydrate loading is prescribed by the admitting physician in the orthopedic outpatient clinic based on the following criteria:
Indications:
Elective surgical procedure
Total knee or hip arthroplasty (TKA, THA)
Age ≥ 18 years
Contraindications:
Diabetes mellitus requiring insulin therapy
Carbohydrate drink schedule:
Preoperative day: PreOp 200 ml at 18:00
Day of surgery: PreOp 200 ml no later than 2 hours before anesthesia
In cases of gastrointestinal motility disorders or significant hiatal hernia, the preoperative fasting window is extended up to 4 hours. If the patient is scheduled first on the operating list, the morning dose is administered postoperatively in the ICU - Intensive Care Unit. The PreOp drink is stored refrigerated on the ward for improved taste.
Carbohydrate loading is monitored using a dedicated form ("Preoperative Preparation - Carbohydrate Loading"), given to the patient during education. The form includes patient identification, instructions, a checklist calendar, and a taste rating section. Patients record the volume consumed, which is verified by nursing staff. The completed form is placed in the patient's medical record and, after ICU discharge, stored in the departmental file accessible to the clinical dietitian.
Mechanical Bowel Preparation
Patients do not undergo mechanical bowel preparation if:
They had a bowel movement on the day before surgery
They have regular bowel habits and no chronic constipation
If necessary, a glycerin suppository is the first-line method. If ineffective, more invasive methods such as a rectal enema may be considered.
Oral Intake After Surgery Oral intake is resumed immediately postoperatively once the patient regains consciousness. The first postoperative meal is dinner, including a late-night snack, which follows the hospital's low-residue diet protocol.
On the day of surgery, patients are prescribed a low-residue diet (Diet No. 5) with applicable modifications (5MM, 5ML, 5BML, 0/5). Diabetic patients or those with impaired glucose tolerance receive a diabetic low-residue diet (Diet No. 9/5) with appropriate modifications (9/5MM, 9/5ML, 90/5).
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Complications
Measurement: Number and type of complications documented in the patient's medical records during hospitalization and up to discharge, including infections, aspiration, and other clinical events.
Measured: 2 weeks postoperatively
Secondary outcomes (2)
Length of Hospital Stay
Number of days from the date of surgery to the date of hospital discharge, as recorded in the hospital information system (NIS-SP).
Measured: 2 weeks postoperatively
Wound Healing Status
Clinical assessment of wound healing based on medical documentation and nursing records, including presence of wound dehiscence, delayed healing, or surgical site infection, evaluated until discharge.
Measured: 2 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative OutcomesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Anne's University Hospital Brno, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasileios Apostolopoulos, St. Anne's University Hospital Brno, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989229
- Sponsor's protocol ID
- 7V/2025
- Status last verified
- Oct 2026
- First submitted
- 13 May 2025
- Last updated
- 13 Oct 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Impact of Perioperative Nutritional Care in Patients Undergoing Total Knee and Hip Arthroplasty on Postoperative Outcomes
- ClinicalTrials.gov ID
- NCT06989229
- Acronym / sponsor ID
- 7V/2025
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- St. Anne's University Hospital Brno, Czech RepublicUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 May 2025 (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.
This prospective observational study will assess the impact of standardized perioperative nutritional care on postoperative outcomes in patients undergoing elective total hip (THA) or knee arthroplasty (TKA) at the First Department of Orthopaedic Surgery, St. Anne's University Hospital in Brno. The protocol includes preoperative patient education, nutritional risk screening, and carbohydrate loading up to two hours before anesthesia, followed by early postoperative refeeding.
Data collection will include demographic and surgical variables, nutritional status, carbohydrate intake, and the occurrence of intra- and postoperative complications, including infection and delayed wound healing.
As perioperative nutritional care is part of routine clinical practice, the study requires no additional interventions or resources. Results will provide evidence on the effectiveness of structured nutritional support in enhancing recovery and reducing complications after joint replacement surgery.
Detailed description
At the First Department of Orthopaedics of St. Anne's University Hospital in Brno, nutritional intervention is an established and integral part of care for patients undergoing total knee and hip arthroplasty. As part of long-term preoperative preparation, emphasis is placed on patient education and the optimization of their nutritional status even before hospital admission. Education on the importance of proper nutrition is provided through the Patient Academy, where preoperative nutritional risk is also assessed. In patients identified as being at nutritional risk, targeted efforts are made to improve their nutritional status.
Preoperative fasting is an outdated method of preparing for surgical stress and can negatively affect the overall recovery process. Therefore, our clinic focuses on eliminating fasting by using carbohydrate loading, allowing patients to consume a carbohydrate drink up to two hours before the induction of anesthesia. After surgery, early refeeding is consistently applied, which supports faster recovery and reduces the risk of complications.
The aim of this study is to investigate the impact of specialized perioperative nutritional care on postoperative outcomes, with the primary objective being to assess the occurrence of postoperative complications and the length of hospital stay. For this purpose, a wide range of clinical data will be collected and analyzed, including patient age, type of surgery, BMI (body mass index), preoperative nutritional risk, amount of carbohydrate drink consumed (including taste rating), occurrence of intraoperative complications-especially aspiration-and postoperative complications such as infections and wound healing issues, as well as length of hospitalization. Data will be securely stored in the REDCap (Research Electronic Data Capture) system.
The research project will be conducted at the 1st Department of Orthopaedics of St. Anne's University Hospital in Brno (sponsor), and will include all patients undergoing elective total hip (THA) or knee (TKA) arthroplasty for whom carbohydrate loading is indicated. The implementation of the study will not incur any additional costs, as preoperative nutritional care is already a standard and established part of routine care for patients undergoing elective joint replacements. The study will provide important insights into the effectiveness of specialized nutritional care in the perioperative period and its impact on overall postoperative outcomes.
Preoperative Fasting and Nutritional Preparation Preoperative fasting is considered an unsuitable approach to preparing for surgical stress. Therefore, international societies such as ESA - European Society of Anaesthesiology and Intensive Care, ERAS - Enhanced Recovery After Surgery and ESPEN - European Society for Clinical Nutrition and Metabolism recommend minimizing fasting periods to support improved postoperative recovery.
Oral Intake Before Surgery The final meal before surgery is dinner, including a late-night snack, which is part of the low-residue diet provided by the dietary system at St. Anne's University Hospital in Brno. On the day before surgery, patients are routinely prescribed a low-residue diet (Diet No. 5) with possible modifications (5MM, 5ML, 5BML, 0/5). Patients with diabetes mellitus or impaired glucose tolerance are prescribed a diabetic low-residue diet (Diet No. 9/5), with appropriate modifications (9/5MM, 9/5ML, 90/5). Diet orders are entered into the hospital information system (NIS-SP) no later than 14:00 on the day prior to surgery.
Carbohydrate Loading
Carbohydrate loading is prescribed by the admitting physician in the orthopedic outpatient clinic based on the following criteria:
Indications:
Elective surgical procedure
Total knee or hip arthroplasty (TKA, THA)
Age ≥ 18 years
Contraindications:
Diabetes mellitus requiring insulin therapy
Carbohydrate drink schedule:
Preoperative day: PreOp 200 ml at 18:00
Day of surgery: PreOp 200 ml no later than 2 hours before anesthesia
In cases of gastrointestinal motility disorders or significant hiatal hernia, the preoperative fasting window is extended up to 4 hours. If the patient is scheduled first on the operating list, the morning dose is administered postoperatively in the ICU - Intensive Care Unit. The PreOp drink is stored refrigerated on the ward for improved taste.
Carbohydrate loading is monitored using a dedicated form ("Preoperative Preparation - Carbohydrate Loading"), given to the patient during education. The form includes patient identification, instructions, a checklist calendar, and a taste rating section. Patients record the volume consumed, which is verified by nursing staff. The completed form is placed in the patient's medical record and, after ICU discharge, stored in the departmental file accessible to the clinical dietitian.
Mechanical Bowel Preparation
Patients do not undergo mechanical bowel preparation if:
They had a bowel movement on the day before surgery
They have regular bowel habits and no chronic constipation
If necessary, a glycerin suppository is the first-line method. If ineffective, more invasive methods such as a rectal enema may be considered.
Oral Intake After Surgery Oral intake is resumed immediately postoperatively once the patient regains consciousness. The first postoperative meal is dinner, including a late-night snack, which follows the hospital's low-residue diet protocol.
On the day of surgery, patients are prescribed a low-residue diet (Diet No. 5) with applicable modifications (5MM, 5ML, 5BML, 0/5). Diabetic patients or those with impaired glucose tolerance receive a diabetic low-residue diet (Diet No. 9/5) with appropriate modifications (9/5MM, 9/5ML, 90/5).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients to undergo elective total hip and knee arthroplasty
Key inclusion criteria (1 listed)
- Elective total hip replacement Elective total knee replacement
Key exclusion criteria (1 listed)
- Hip fracture Diabetes mellitus 1 Insulinotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Postoperative Complications
Time frame: 2 weeks postoperatively
Measurement: Number and type of complications documented in the patient's medical records during hospitalization and up to discharge, including infections, aspiration, and other clinical events.
2 secondary outcomes
Length of Hospital Stay
Time frame: 2 weeks postoperatively
Wound Healing Status
Time frame: 2 weeks 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 13 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Outcomes and Postoperative Complications, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
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 1 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 13 Oct 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 Czechia. 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 Vasileios Apostolopoulos, M.D., Ph.D. (+420722101065, vasileios.apostolopoulos@fnusa.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Complications (time frame: 2 weeks postoperatively). 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 Oct 2026.