SurgeryNCT05535205
Effectiveness and Costs of a Digital Versus Face-to-face Preoperative Assessment Clinic
A study testing Digital preoperative assessment and Face-to-face preoperative assessment in people with Surgery, run by Diakonessenhuis, Utrecht at 1 site in Netherlands.
Trial summary
A digital preoperative assessment clinic provides a solution for the increasing demand and declining performance on waiting times for surgery, while conducting assessments to a high standard. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- Digital preoperative assessment and Face-to-face preoperative assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2021to 5 Sep 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients to the PAC department with a request of undergoing surgery
- 18 and older
- ASA classification I to IV
- general surgery (vascular, traumatic, gastrointestinal, oncological), gynecology, otolaryngology, neurosurgery, plastic surgery, orthopedics, and ophthalmology.
- fluent in Dutch
- the availability of an online personal computer at home
- and able to give informed consent.
Who cannot join
- pregnant women
- patients undergoing a non-standard pre-operative assessment procedure which included breast- and gastrointestinal oncology and cardiac procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Costs of a Digital Versus Face-to-face Preoperative Assessment Clinic: a Non-inferiority Trial
A digital preoperative assessment clinic provides a solution for the increasing demand and declining performance on waiting times for surgery, while conducting assessments to a high standard. However, it remains unclear if a digital preoperative assessment is as effective as a face-to-face clinic in terms of patient health outcomes and experience compared. This study aimed to compare quality or recovery and overall patient experience in patients undergoing a digital preoperative assessment versus regular face-to-face consultations.
Read the detailed description
Study design This is a randomized (1:1), open label, noninferiority trial performed at 2 locations of a Dutch, urban, secondary care hospital.
Aims
- demonstrate the noninferiority of a digital PAC, in terms of postoperative quality of recovery, compared with a face-to-face PAC, and
- demonstrate if there is a difference in preoperative anxiety, decisional conflict, patient satisfaction, morbidity, mortality, American Society of Anesthesiologists score (ASA) reliability, and costs.
Study population Participants aged 18 and older admitted to the PAC department with a request of undergoing surgery were evaluated for study enrollment. The trial inclusion criteria are age 18 and older, ASA classification I to IV, fluent in Dutch, the availability of an online personal computer at home, and able to give informed consent. Exclusion criteria are pregnant women, and patients undergoing a non-standard pre-operative assessment procedure which included breast- and gastrointestinal oncology and cardiac procedures.
Outcomes Primary: Quality of recovery 40 (QOR-40) scale assessed at 48 hours postoperative.
Secondary outcomes (Measured 1 day prior to surgery):
- State-Trait Anxiety Inventory (STAI) form Y1 (also at baseline)
- Decisional conflict scale (DCS)
- Patient satisfaction with information (NR 1-10)
- Patient satisfaction with the screening process (NR 1-10) Measured during the study
- ASA reliability
- Postoperative length of stay
- 30-day complications
- 30-day mortality
- preoperative anesthetic assessment and surgery cancelation
- loan costs
Sample size This sample size calculation will be based on noninferiority tests for the continuous primary outcome quality of recovery score (QoR-40) measured at 48 hours after surgery. The noninferiority margin is set at -6 points, which is based on a study by Myles et al. who found a minimal clinical important difference (MCID) of 6.3 for the QOR-40 questionnaire, which was subsequently rounded down. Based on this study, the expected QoR-40 score was177 with a standard deviation of 16 on postoperative day 2 for the control group (face-to-face consultations). A total of 224 patients, 112 in each group, would yield a power of 80%, using a one-sided 97,5% confidence interval (CI), to establish whether a digital PAC is noninferior compared to a face-to-face PAC. With an estimated dropout rate of 25%, a total of 299 patients (150 patients per group) need to be enrolled.
Analysis Data will be analyzed as per-protocol. A linear mixed effects model will be conducted with study group and QOR-baseline as fixed effects and treating specialism as random effect. The primary outcome of QoR-40 will be presented as the mean difference between study groups (digital screening - face-to-face screening) with the upper and lower bound of the 95% CI and will be labelled non-inferior when the non-inferiority margin of -6 lies outside the lower bound of the 95% CI. CIs will be calculated using linear regression analysis.
- Conditions
- Surgery
- Being tested
- Digital preoperative assessment, Face-to-face preoperative assessment
- Keywords
- Preoperative assessment clinic, Preoperative anesthetic screening, Patients requiring surgery, Surgical patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital preoperative assessmentOther
a digital preoperative assessment for patient requiring surgery
Face-to-face preoperative assessmentOther
a face-to-face preoperative assessment for patient requiring surgery
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face preoperative assessment group | Active comparator | The face-to-face screening consist of two 20-minute consecutive consultations with a nurse and subsequently an anesthesiologist or PA. The nurse obtains basic patient health information, provides information on the upcoming hospital admission, and gives advice in lifestyle procedures around the surgery. The physician assesses the patient's health status based on co-morbidities, medication use, previous surgery, and lifestyle habits to predict preoperative risks and determine the optimal anesthetic technique. Additional diagnostics, such as blood tests or electrocardiogram, can be ordered and optional anesthetic techniques will subsequently be presented and discussed with the patient, after which informed consent will be obtained. Receives: Other: Face-to-face preoperative assessment |
| Digital preoperative assessment group | Active comparator | Patients in the digital preoperative assessment group are asked to complete an electronic screening questionnaire through the digital patient portal of the hospital. The questionnaire was designed by the anesthetic department physicians and consisted of 50 health related questions. Through the same digital patient portal, patients have access to animated instructional videos that provides information on anesthetic techniques, preoperative lifestyle advises and procedures around the upcoming surgery. The videos can be reviewed at any desired moment in time. A telephone appointment is scheduled solemnly to decide on the anesthesia technique and obtain informed consent since this process was technically not available in the electronic portal. Physicians were thoroughly instructed not to provide more information or answer questions. Patients are instructed to complete the electronic screening questionnaire and assess the animated videos before the scheduled appointment with the physician. Receives: Other: Digital preoperative assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery 40 (QOR-40) scale
The QoR-40 is a validated composite endpoint that can be used to evaluate anesthetic or surgical procedure. The questionnaire consists of 40 questions on a 5-point Likert scale that provides a global score and sub scores across five dimensions: patient support, comfort, emotions, physical independence, and pain. The highest achievable score, indicating maximum quality of recovery, is 200. The lowest score, indicating worst quality of recovery, is 40. The questions are related to the quality of recovery over the past 24 hours.
Measured: Measured 48 hours postoperative
Secondary outcomes (9)
State-Trait Anxiety Inventory (STAI) form Y1
A psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Higher scores are positively correlated with higher levels of anxiety. The range of possible scores of the STAI varies from a minimum score of 20 (minimum anxiety) to a maximum score of 80 (maximum anxiety)
Measured: Measured at 24 hours preoperative
Decisional conflict scale (DCS)
The decisional conflict scale (DCS) measures personal perceptions of:
uncertainty in choosing options; modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making (in full version) such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice.
Scores range from 0, no decisional conflict, to 100, extremely high decisional conflict.
Measured: Measured at 24 hours preoperative
Patient satisfaction with the information
On a NR-scale from 1-10. 1 is least satisfied, 10 is most satisfied.
Measured: Measured at 24 hours preoperative
Patient satisfaction with the entire screening process
On a NR-scale from 1-10. 1 is least satisfied, 10 is most satisfied.
Measured: Measured at 24 hours preoperative
ASA score reliability
Reliability of the ASA score administered by the physician during the PAC and the ASA score administered by the physician just before surgery. Reliability is presented as quadratic weighted kappa values: 0 is low agreement, 1 is perfect agreement.
Measured: During the PAC and just before surgery (1-2 hours)
Postoperative length of stay
in days
Measured: until 30 days after surgery
30-day complications and mortality
Complications due to surgery or anesthesia are registered, as well as 30-day mortality
Measured: until 30 days after surgery
Cancelation of PAC appointment or cancelation of surgery
Number of PAC appointment cancellations and cancelled surgeries. Each cancelled appointment of surgery is registered in the medical record an retrospectively assessed.
Measured: This is measured from moment of randomization to moment of surgery, which is on average 2 months from randomization.
Loan costs
Difference in loan costs of nurses and physicians
Measured: until 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Mar 2021
- Primary completion1 Jul 2022
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonessenhuis, Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reinier Tromp Meesters, Msc, Study chair, Diakonessenhuis, UtrechtMark van Heijl, PhD, Study chair, Diakonessenhuis, Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535205
- Sponsor's protocol ID
- 21-010
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van den Blink A, Janssen LMJ, Hermanides J, Loer SA, Straat FK, Jessurun EN, Schwarte LA, Schober P. Evaluation of electronic screening in the preoperative process. J Clin Anesth. 2022 Nov;82:110941. doi: 10.1016/j.jclinane.2022.110941. Epub 2022 Aug 5.
PubMed 35939972Milne-Ives M, Leyden J, Maramba I, Chatterjee A, Meinert E. The Potential Impacts of a Digital Preoperative Assessment Service on Appointments, Travel-Related Carbon Dioxide Emissions, and User Experience: Case Study. JMIR Perioper Med. 2022 Feb 16;5(1):e28612. doi: 10.2196/28612.
PubMed 35171104Blanco Vargas D, Faura Messa A, Izquierdo Tugas E, Santa-Olalla Bergua M, Noguera Sopena MM, Manoso Noriego M. [Online versus non-standard face to face preoperative assessment: cost effectiveness]. Rev Esp Anestesiol Reanim. 2012 Aug-Sep;59(7):350-6. doi: 10.1016/j.redar.2012.05.039. Epub 2012 Jul 10. Spanish.
PubMed 22784647Howell M, Hood AJ, Jayne DG. Use of a patient completed iPad questionnaire to improve pre-operative assessment. J Clin Monit Comput. 2017 Feb;31(1):221-225. doi: 10.1007/s10877-015-9818-0. Epub 2015 Dec 29.
PubMed 26715416Taylor SK, Andrzejowski JC, Wiles MD, Bland S, Jones GL, Radley SC. A prospective observational study of the impact of an electronic questionnaire (ePAQ-PO) on the duration of nurse-led pre-operative assessment and patient satisfaction. PLoS One. 2018 Oct 19;13(10):e0205439. doi: 10.1371/journal.pone.0205439. eCollection 2018.
PubMed 30339687Osman T, Lew E, Lum EP, van Galen L, Dabas R, Sng BL, Car J. PreAnaesThesia computerized health (PATCH) assessment: development and validation. BMC Anesthesiol. 2020 Nov 14;20(1):286. doi: 10.1186/s12871-020-01202-8.
PubMed 33189131van Hoorn BT, Tromp DJ, van Rees RCM, van Rossenberg LX, Cazemier HK, van Heijl M, Tromp Meesters RC. Effectiveness of a digital vs face-to-face preoperative assessment: A randomized, noninferiority clinical trial. J Clin Anesth. 2023 Nov;90:111192. doi: 10.1016/j.jclinane.2023.111192. Epub 2023 Jul 18.
PubMed 37467628
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Costs of a Digital Versus Face-to-face Preoperative Assessment Clinic: a Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05535205
- Acronym / sponsor ID
- 21-010
- Conditions
- Surgery
- Keywords
- Preoperative assessment clinic, Preoperative anesthetic screening, Patients requiring surgery, Surgical patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Diakonessenhuis, UtrechtUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 10 Sep 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.
A digital preoperative assessment clinic provides a solution for the increasing demand and declining performance on waiting times for surgery, while conducting assessments to a high standard. However, it remains unclear if a digital preoperative assessment is as effective as a face-to-face clinic in terms of patient health outcomes and experience compared. This study aimed to compare quality or recovery and overall patient experience in patients undergoing a digital preoperative assessment versus regular face-to-face consultations.
Detailed description
Study design This is a randomized (1:1), open label, noninferiority trial performed at 2 locations of a Dutch, urban, secondary care hospital.
Aims
- demonstrate the noninferiority of a digital PAC, in terms of postoperative quality of recovery, compared with a face-to-face PAC, and
- demonstrate if there is a difference in preoperative anxiety, decisional conflict, patient satisfaction, morbidity, mortality, American Society of Anesthesiologists score (ASA) reliability, and costs.
Study population Participants aged 18 and older admitted to the PAC department with a request of undergoing surgery were evaluated for study enrollment. The trial inclusion criteria are age 18 and older, ASA classification I to IV, fluent in Dutch, the availability of an online personal computer at home, and able to give informed consent. Exclusion criteria are pregnant women, and patients undergoing a non-standard pre-operative assessment procedure which included breast- and gastrointestinal oncology and cardiac procedures.
Outcomes Primary: Quality of recovery 40 (QOR-40) scale assessed at 48 hours postoperative.
Secondary outcomes (Measured 1 day prior to surgery):
- State-Trait Anxiety Inventory (STAI) form Y1 (also at baseline)
- Decisional conflict scale (DCS)
- Patient satisfaction with information (NR 1-10)
- Patient satisfaction with the screening process (NR 1-10) Measured during the study
- ASA reliability
- Postoperative length of stay
- 30-day complications
- 30-day mortality
- preoperative anesthetic assessment and surgery cancelation
- loan costs
Sample size This sample size calculation will be based on noninferiority tests for the continuous primary outcome quality of recovery score (QoR-40) measured at 48 hours after surgery. The noninferiority margin is set at -6 points, which is based on a study by Myles et al. who found a minimal clinical important difference (MCID) of 6.3 for the QOR-40 questionnaire, which was subsequently rounded down. Based on this study, the expected QoR-40 score was177 with a standard deviation of 16 on postoperative day 2 for the control group (face-to-face consultations). A total of 224 patients, 112 in each group, would yield a power of 80%, using a one-sided 97,5% confidence interval (CI), to establish whether a digital PAC is noninferior compared to a face-to-face PAC. With an estimated dropout rate of 25%, a total of 299 patients (150 patients per group) need to be enrolled.
Analysis Data will be analyzed as per-protocol. A linear mixed effects model will be conducted with study group and QOR-baseline as fixed effects and treating specialism as random effect. The primary outcome of QoR-40 will be presented as the mean difference between study groups (digital screening - face-to-face screening) with the upper and lower bound of the 95% CI and will be labelled non-inferior when the non-inferiority margin of -6 lies outside the lower bound of the 95% CI. CIs will be calculated using linear regression analysis.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-to-face preoperative assessment group | Active comparator | Other: Face-to-face preoperative assessmentThe face-to-face screening consist of two 20-minute consecutive consultations with a nurse and subsequently an anesthesiologist or PA. The nurse obtains basic patient health information, provides information on the upcoming hospital admission, and gives advice in lifestyle procedures around the surgery. The physician assesses the patient's health status based on co-morbidities, medication use, previous surgery, and lifestyle habits to predict preoperative risks and determine the optimal anesthetic technique. Additional diagnostics, such as blood tests or electrocardiogram, can be ordered and optional anesthetic techniques will subsequently be presented and discussed with the patient, after which informed consent will be obtained. |
| Digital preoperative assessment group | Active comparator | Other: Digital preoperative assessmentPatients in the digital preoperative assessment group are asked to complete an electronic screening questionnaire through the digital patient portal of the hospital. The questionnaire was designed by the anesthetic department physicians and consisted of 50 health related questions. Through the same digital patient portal, patients have access to animated instructional videos that provides information on anesthetic techniques, preoperative lifestyle advises and procedures around the upcoming surgery. The videos can be reviewed at any desired moment in time. A telephone appointment is scheduled solemnly to decide on the anesthesia technique and obtain informed consent since this process was technically not available in the electronic portal. Physicians were thoroughly instructed not to provide more information or answer questions. Patients are instructed to complete the electronic screening questionnaire and assess the animated videos before the scheduled appointment with the physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients to the PAC department with a request of undergoing surgery
- 18 and older
- ASA classification I to IV
- general surgery (vascular, traumatic, gastrointestinal, oncological), gynecology, otolaryngology, neurosurgery, plastic surgery, orthopedics, and ophthalmology.
- fluent in Dutch
Key exclusion criteria (2 listed)
- pregnant women
- patients undergoing a non-standard pre-operative assessment procedure which included breast- and gastrointestinal oncology and cardiac procedures.
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 |
|---|---|---|
| Digital preoperative assessmenta digital preoperative assessment for patient requiring surgery | Other | Digital preoperative assessment group |
| Face-to-face preoperative assessmenta face-to-face preoperative assessment for patient requiring surgery | Other | Face-to-face preoperative assessment group |
Primary outcome
Quality of recovery 40 (QOR-40) scale
Time frame: Measured 48 hours postoperative
The QoR-40 is a validated composite endpoint that can be used to evaluate anesthetic or surgical procedure. The questionnaire consists of 40 questions on a 5-point Likert scale that provides a global score and sub scores across five dimensions: patient support, comfort, emotions, physical independence, and pain. The highest achievable score, indicating maximum quality of recovery, is 200. The lowest score, indicating worst quality of recovery, is 40. The questions are related to the quality of recovery over the past 24 hours.
9 secondary outcomes
State-Trait Anxiety Inventory (STAI) form Y1
Time frame: Measured at 24 hours preoperative
Decisional conflict scale (DCS)
Time frame: Measured at 24 hours preoperative
Patient satisfaction with the information
Time frame: Measured at 24 hours preoperative
Patient satisfaction with the entire screening process
Time frame: Measured at 24 hours preoperative
ASA score reliability
Time frame: During the PAC and just before surgery (1-2 hours)
Postoperative length of stay
Time frame: until 30 days after surgery
30-day complications and mortality
Time frame: until 30 days after surgery
Cancelation of PAC appointment or cancelation of surgery
Time frame: This is measured from moment of randomization to moment of surgery, which is on average 2 months from randomization.
Loan costs
Time frame: until 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Background: PubMed 35939972van den Blink A, Janssen LMJ, Hermanides J, Loer SA, Straat FK, Jessurun EN, Schwarte LA, Schober P. Evaluation of electronic screening in the preoperative process. J Clin Anesth. 2022 Nov;82:110941. doi: 10.1016/j.jclinane.2022.110941. Epub 2022 Aug 5.
- Results publication: PubMed 35171104Milne-Ives M, Leyden J, Maramba I, Chatterjee A, Meinert E. The Potential Impacts of a Digital Preoperative Assessment Service on Appointments, Travel-Related Carbon Dioxide Emissions, and User Experience: Case Study. JMIR Perioper Med. 2022 Feb 16;5(1):e28612. doi: 10.2196/28612.
- Results publication: PubMed 22784647Blanco Vargas D, Faura Messa A, Izquierdo Tugas E, Santa-Olalla Bergua M, Noguera Sopena MM, Manoso Noriego M. [Online versus non-standard face to face preoperative assessment: cost effectiveness]. Rev Esp Anestesiol Reanim. 2012 Aug-Sep;59(7):350-6. doi: 10.1016/j.redar.2012.05.039. Epub 2012 Jul 10. Spanish.
- Results publication: PubMed 26715416Howell M, Hood AJ, Jayne DG. Use of a patient completed iPad questionnaire to improve pre-operative assessment. J Clin Monit Comput. 2017 Feb;31(1):221-225. doi: 10.1007/s10877-015-9818-0. Epub 2015 Dec 29.
- Results publication: PubMed 30339687Taylor SK, Andrzejowski JC, Wiles MD, Bland S, Jones GL, Radley SC. A prospective observational study of the impact of an electronic questionnaire (ePAQ-PO) on the duration of nurse-led pre-operative assessment and patient satisfaction. PLoS One. 2018 Oct 19;13(10):e0205439. doi: 10.1371/journal.pone.0205439. eCollection 2018.
- Results publication: PubMed 33189131Osman T, Lew E, Lum EP, van Galen L, Dabas R, Sng BL, Car J. PreAnaesThesia computerized health (PATCH) assessment: development and validation. BMC Anesthesiol. 2020 Nov 14;20(1):286. doi: 10.1186/s12871-020-01202-8.
- Derived from this study: PubMed 37467628van Hoorn BT, Tromp DJ, van Rees RCM, van Rossenberg LX, Cazemier HK, van Heijl M, Tromp Meesters RC. Effectiveness of a digital vs face-to-face preoperative assessment: A randomized, noninferiority clinical trial. J Clin Anesth. 2023 Nov;90:111192. doi: 10.1016/j.jclinane.2023.111192. Epub 2023 Jul 18.
- 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. This study is not recruiting at the moment.
Reinier Tromp Meesters, Msc study chair
Diakonessenhuis, Utrecht
Mark van Heijl, PhD study chair
Diakonessenhuis, Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital preoperative assessment and Face-to-face preoperative assessment in people with Surgery, run by Diakonessenhuis, Utrecht at 1 site in Netherlands.
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 7 inclusion and 2 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: finished, as of the sponsor's last update on 10 Sep 2022. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of recovery 40 (QOR-40) scale (time frame: Measured 48 hours postoperative). 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 NCT05535205, which also lists 7 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 10 Sep 2022.