Colorectal CancerPrehabVsERASNCT03758209
Prehabilitation Versus Enhanced Recovery Program for Elective Colorectal Cancer Surgery.
A study testing Prehabilitation + ERAS and ERAS in people with Colorectal Cancer and Insulin Resistance, run by St. Borbala Hospital at 1 site in Hungary.
Trial summary
Elective surgery is the most effective treatment option for colorectal cancer, however it has been recognized to be associated with high morbidity and mortality risks. ERAS (Enhanced Recovery After Surgery) is a preoperative multimodality treatment package, which has been well investigated and proved to be effective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Insulin Resistance
- What is being tested?
- Prehabilitation + ERAS and ERAS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteHungary
- Study dates
- 1 Nov 2018to 1 Nov 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with histologically proven primary colorectal adenocarcinoma
- any stage of colorectal cancer
- elective operation
- curative intention
- informed consent signed by patient
Who cannot join
- emergency operation
- palliative operation
- non-colorectal, second malignancy
- pregnancy
- patient not giving consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Preoperative Multimodal Preparation Program (Prehabilitation) With Enhanced Recovery Program for Elective Colorectal Cancer Surgery.
Elective surgery is the most effective treatment option for colorectal cancer, however it has been recognized to be associated with high morbidity and mortality risks.
ERAS (Enhanced Recovery After Surgery) is a preoperative multimodality treatment package, which has been well investigated and proved to be effective in reducing early postoperative morbidity, mortality, length of hospital stay and hospital costs, as well. Still, a good proportion of patients are not suitable for ERAS program, mainly based on lack of compliance and the impaired physical function before surgery.
Read more
Prehabilitation Program is a recently introduced trimodal preoperative preparation (training) program, which addresses improvement of physical, mental and nutritional status of the high risk elective surgery patients.
This study aims to investigate the benefit of all efforts of a 4-6-week preoperative preparation program (Prehabilitation) being added to an established ERAS protocol.
Read the detailed description
Aim:
Colorectal cancer patients with a planned resection are tested if a complex, trimodal rehabilitation program can hold functional and morbidity benefit for them.
In the prospective, randomized (1:1) study control patient group will be the well established and tested ERAS (enhanced recovery after surgery) Program.
Study protocol in details:
- First visit: Outpatient Department of Surgery On both arms:
- History taking (including family history and oncologic history);
- Physical examination
- Operation indication, type of procedure and date of procedure agreed;
- Organizing further investigations, anesthesia;
- Operative risk assessment ("ACS - surgical risk calculator");
- Study patient identifier Nr generated;
- Nurse-led ERAS/Prehab clinic: randomization On both arms:
- Randomization (Prehabilitation Program / ERAS Program).
- Nurse led clinic assessment ("study nurse"): .i. CaseReportForm (CRF) filled in. .ii. Patient data (personal data, demographics, history) .iii. Anthropometrics (BMI, MUST, Body fat % measurement). .iv. Mental hygienic status assessment (smoking, alcohol consumption, anxiety, depression, sleeping disorders). .v. Cardiovascular status (resting HR, RR). .vi. Operative risk assessment (CR-Possum score). .vii. Preoperative counseling (operation type, preparation, pain management, discharge plan). .viii. Preoperative nutritional planning (education, nutrient prescription). .ix. Alcohol intake and smoking cessation - information given. .x. Stoma education started. .xi. Consent signed, patient workbook handed over. .xii. Respiratory test referral.
- Physiotherapy, first visit Both on control and interventional arms:
- Respiratory function test recorded.
- Physical status tested (6MWD) on a treadmill. Just on Prehabilitation arm:
- Respiratory training education.
- Respiratory trainer device usage educated.
- Daily activity (walking) planned.
- Physiotherapy - second/third/fourth visit (weekly) Just on Prehabilitation arm:
- Previous week activity reviewed as to workbook.
- Physical assessment: 6MWD, FVC.
- Next week activity planned.
- Psychic preparation Just on Prehabilitation arm:
- Once a week half an hour group relaxation training - regardless of the stage of prehabilitation program.
- Admission to the Surgical Ward a day before surgery Both on control and interventional arm:
- Preoperative assessment: .i. Anthropometrics (BMI, body fat%). .ii. Cardiovascular stage (resting HR and RR), ECG. .iii. Respiratory function tests. .iv. Physical status (6MWD) .v. Mental status (Hospital Anxiety and Depression Scale (HADS)) assessment.
- Preoperative preparation (as to ERAS protocol).
- Postoperative care (ITU, pain management, mobilization, oral nutrition built up, drains early removal, complications recorded (Clavien-Dindo-classification)).
- Stoma education.
- Dietary education.
- On discharge: Quality of Life (QoL) SF36 - (36-Item Short Form Survey from the RAND Medical Outcomes Study).
- Postoperative follow up:
Both on control and interventional arms:
- Assessment (4th and 8th week post op.):
.i. Anthropometrics (BMI, Body fat %) .ii. Cardiovascular status (resting HR and RR). .iii. Respiratory function tests. .iv. Physical status (6MWD).
- Conditions
- Colorectal Cancer, Insulin Resistance
- Being tested
- Prehabilitation + ERAS, ERAS
- Keywords
- Morbidity, Mortality, Complication, Prehabilitation, ERAS
- Medical subject headings
- Colorectal Neoplasms, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation + ERASProcedure or surgery
Prehabilitation will cover a range preoperative education and exercises (weekly) on diet, physical activity (daily walking), respiratory training (forced deep inspiration with spirometer device), as well as anxiolytic group psychotherapy.
ERASProcedure or surgery
Also called Enhanced Recovery After Surgery Program
Enhanced Recovery Program, including preoperative 4 weeks nutritional supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation + ERAS | Experimental | Patients receiving a formal preoperative preparation on:
* Physical status (walking, respiratory training)
* Nutrition (nutritional supplements)
* Mental status (weekly groups led by clinical psychologist on anxiety and depression management).
Each patient will be treated in an ERAS program preoperatively. Receives: Procedure: Prehabilitation + ERAS; Procedure: ERAS |
| ERAS | Active comparator | Each patient will be treated in an ERAS program preoperatively. No specific preoperative training will be involved apart from nutritional status assessment and nutritional supplements. Receives: Procedure: ERAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Postoperative length of hospital stay in days.
Measured: within 45 days
Number of days spent on ICU (Intensive care unit).
Number of days observed on ICU right after operation.
Measured: within 45 days postoperative
Morbidity (early) classified after Clavien-Dindo.
7-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.
Measured: 7 days (until 8th postoperative day) postoperative
Morbidity (long term) classified after Clavien-Dindo.
30-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.
Measured: 30 days (until 31st postoperative day)
30-day mortality
30-day mortality of each patient will be recorded.
Measured: 30 days postoperative
90-day mortality
90-day mortality of each patient will be recorded.
Measured: 90 days postoperative
Change in preoperative functional status - 6MWD by operation
6MWD (6-minute walking distance test)
Measured: Measured points: 4 weeks before surgery, on day of hospital admission
Change in postoperative functional status - 6MWD by the end of rehabilitation
6MWD (6-minute walking distance test)
Measured: Measured points: 4 weeks before surgery, 8 weeks after operation
Change in preoperative functional status - FVC by operation
FVC (forced vital capacity) will be measured.
Measured: Measured points: 4 weeks before surgery, on day of hospital admission
Change in preoperative functional status - FVC by the end of rehabilitation
FVC (forced vital capacity) will be measured.
Measured: Measured points: 4 weeks before surgery, 8 weeks after operation
Secondary outcomes (1)
Delay in beginning of adjuvant oncotherapy (chemotherapy, radiotherapy).
Sufficient recovery time until fitness of adjuvant chemo/radiotherapy will be recorded.
Measured: within 8 weeks, if adjuvant oncotherapy is needed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Nov 2018
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients planned for elective, curative operations for colorectal cancer will be randomized into two groups: experimental group will take part in a dedicated 4-week multimodal preparation program followed by ERAS preoperative management, while control group will just participate in the ERAS program without specific physical and mental preparation. 1:1 randomization will be performed.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Borbala Hospital
- Sponsor type
- Other government
- Collaborators
- St. Borbala Hospital, Department of Surgery, Semmelweis University
- Responsible party
- Principal investigator, Dr. Balázs Bánky PhD, St. Borbala Hospital
- Investigators
- Balázs Bánky, PhD, Study director, Department of Surgery, St. Borbala Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758209
- Sponsor's protocol ID
- 48931-2/2018/EKU ETT-TUKEB
- Acronym
- PrehabVsERAS
- Status last verified
- Mar 2020
- First submitted
- 27 Nov 2018
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Souwer ETD, Bastiaannet E, de Bruijn S, Breugom AJ, van den Bos F, Portielje JEA, Dekker JWT. Comprehensive multidisciplinary care program for elderly colorectal cancer patients: "From prehabilitation to independence". Eur J Surg Oncol. 2018 Dec;44(12):1894-1900. doi: 10.1016/j.ejso.2018.08.028. Epub 2018 Sep 8.
PubMed 30266205Bousquet-Dion G, Awasthi R, Loiselle SE, Minnella EM, Agnihotram RV, Bergdahl A, Carli F, Scheede-Bergdahl C. Evaluation of supervised multimodal prehabilitation programme in cancer patients undergoing colorectal resection: a randomized control trial. Acta Oncol. 2018 Jun;57(6):849-859. doi: 10.1080/0284186X.2017.1423180. Epub 2018 Jan 12.
PubMed 29327644Chen BP, Awasthi R, Sweet SN, Minnella EM, Bergdahl A, Santa Mina D, Carli F, Scheede-Bergdahl C. Four-week prehabilitation program is sufficient to modify exercise behaviors and improve preoperative functional walking capacity in patients with colorectal cancer. Support Care Cancer. 2017 Jan;25(1):33-40. doi: 10.1007/s00520-016-3379-8. Epub 2016 Aug 18.
PubMed 27539131Carli F, Silver JK, Feldman LS, McKee A, Gilman S, Gillis C, Scheede-Bergdahl C, Gamsa A, Stout N, Hirsch B. Surgical Prehabilitation in Patients with Cancer: State-of-the-Science and Recommendations for Future Research from a Panel of Subject Matter Experts. Phys Med Rehabil Clin N Am. 2017 Feb;28(1):49-64. doi: 10.1016/j.pmr.2016.09.002.
PubMed 27913000Banky B, Lakatos M, Varga K, Hansagi E, Horvath E, Jaray G. [Enhanced Recovery Program in colorectal surgery]. Magy Seb. 2018 Mar;71(1):3-11. doi: 10.1556/1046.71.2018.1.1. Hungarian.
PubMed 29536753
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Preoperative Multimodal Preparation Program (Prehabilitation) With Enhanced Recovery Program for Elective Colorectal Cancer Surgery.
- ClinicalTrials.gov ID
- NCT03758209
- Acronym / sponsor ID
- PrehabVsERAS / 48931-2/2018/EKU ETT-TUKEB
- Conditions
- Colorectal Cancer, Insulin Resistance
- Keywords
- Morbidity, Mortality, Complication, Prehabilitation, ERAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- St. Borbala HospitalOther government
- Collaborators
- St. Borbala Hospital, Department of Surgery, Semmelweis University
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 29 Nov 2018 (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.
Elective surgery is the most effective treatment option for colorectal cancer, however it has been recognized to be associated with high morbidity and mortality risks.
ERAS (Enhanced Recovery After Surgery) is a preoperative multimodality treatment package, which has been well investigated and proved to be effective in reducing early postoperative morbidity, mortality, length of hospital stay and hospital costs, as well. Still, a good proportion of patients are not suitable for ERAS program, mainly based on lack of compliance and the impaired physical function before surgery.
Prehabilitation Program is a recently introduced trimodal preoperative preparation (training) program, which addresses improvement of physical, mental and nutritional status of the high risk elective surgery patients.
This study aims to investigate the benefit of all efforts of a 4-6-week preoperative preparation program (Prehabilitation) being added to an established ERAS protocol.
Detailed description
Aim:
Colorectal cancer patients with a planned resection are tested if a complex, trimodal rehabilitation program can hold functional and morbidity benefit for them.
In the prospective, randomized (1:1) study control patient group will be the well established and tested ERAS (enhanced recovery after surgery) Program.
Study protocol in details:
- First visit: Outpatient Department of Surgery On both arms:
- History taking (including family history and oncologic history);
- Physical examination
- Operation indication, type of procedure and date of procedure agreed;
- Organizing further investigations, anesthesia;
- Operative risk assessment ("ACS - surgical risk calculator");
- Study patient identifier Nr generated;
- Nurse-led ERAS/Prehab clinic: randomization On both arms:
- Randomization (Prehabilitation Program / ERAS Program).
- Nurse led clinic assessment ("study nurse"): .i. CaseReportForm (CRF) filled in. .ii. Patient data (personal data, demographics, history) .iii. Anthropometrics (BMI, MUST, Body fat % measurement). .iv. Mental hygienic status assessment (smoking, alcohol consumption, anxiety, depression, sleeping disorders). .v. Cardiovascular status (resting HR, RR). .vi. Operative risk assessment (CR-Possum score). .vii. Preoperative counseling (operation type, preparation, pain management, discharge plan). .viii. Preoperative nutritional planning (education, nutrient prescription). .ix. Alcohol intake and smoking cessation - information given. .x. Stoma education started. .xi. Consent signed, patient workbook handed over. .xii. Respiratory test referral.
- Physiotherapy, first visit Both on control and interventional arms:
- Respiratory function test recorded.
- Physical status tested (6MWD) on a treadmill. Just on Prehabilitation arm:
- Respiratory training education.
- Respiratory trainer device usage educated.
- Daily activity (walking) planned.
- Physiotherapy - second/third/fourth visit (weekly) Just on Prehabilitation arm:
- Previous week activity reviewed as to workbook.
- Physical assessment: 6MWD, FVC.
- Next week activity planned.
- Psychic preparation Just on Prehabilitation arm:
- Once a week half an hour group relaxation training - regardless of the stage of prehabilitation program.
- Admission to the Surgical Ward a day before surgery Both on control and interventional arm:
- Preoperative assessment: .i. Anthropometrics (BMI, body fat%). .ii. Cardiovascular stage (resting HR and RR), ECG. .iii. Respiratory function tests. .iv. Physical status (6MWD) .v. Mental status (Hospital Anxiety and Depression Scale (HADS)) assessment.
- Preoperative preparation (as to ERAS protocol).
- Postoperative care (ITU, pain management, mobilization, oral nutrition built up, drains early removal, complications recorded (Clavien-Dindo-classification)).
- Stoma education.
- Dietary education.
- On discharge: Quality of Life (QoL) SF36 - (36-Item Short Form Survey from the RAND Medical Outcomes Study).
- Postoperative follow up:
Both on control and interventional arms:
- Assessment (4th and 8th week post op.):
.i. Anthropometrics (BMI, Body fat %) .ii. Cardiovascular status (resting HR and RR). .iii. Respiratory function tests. .iv. Physical status (6MWD).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients planned for elective, curative operations for colorectal cancer will be randomized into two groups: experimental group will take part in a dedicated 4-week multimodal preparation program followed by ERAS preoperative management, while control group will just participate in the ERAS program without specific physical and mental preparation. 1:1 randomization will be performed.
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation + ERAS | Experimental | Procedure: Prehabilitation + ERAS, Procedure: ERASPatients receiving a formal preoperative preparation on: * Physical status (walking, respiratory training) * Nutrition (nutritional supplements) * Mental status (weekly groups led by clinical psychologist on anxiety and depression management). Each patient will be treated in an ERAS program preoperatively. |
| ERAS | Active comparator | Procedure: ERASEach patient will be treated in an ERAS program preoperatively. No specific preoperative training will be involved apart from nutritional status assessment and nutritional supplements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patient with histologically proven primary colorectal adenocarcinoma
- any stage of colorectal cancer
- elective operation
- curative intention
- informed consent signed by patient
Key exclusion criteria (5 listed)
- emergency operation
- palliative operation
- non-colorectal, second malignancy
- pregnancy
- patient not giving consent
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 |
|---|---|---|
| Prehabilitation + ERASPrehabilitation will cover a range preoperative education and exercises (weekly) on diet, physical activity (daily walking), respiratory training (forced deep inspiration with spirometer device), as well as anxiolytic group psychotherapy. | Procedure or surgery | Prehabilitation + ERAS |
| ERASAlso: Enhanced Recovery After Surgery ProgramEnhanced Recovery Program, including preoperative 4 weeks nutritional supplementation. | Procedure or surgery | ERAS, Prehabilitation + ERAS |
Primary outcome
Length of hospital stay
Time frame: within 45 days
Postoperative length of hospital stay in days.
Number of days spent on ICU (Intensive care unit).
Time frame: within 45 days postoperative
Number of days observed on ICU right after operation.
Morbidity (early) classified after Clavien-Dindo.
Time frame: 7 days (until 8th postoperative day) postoperative
7-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.
Morbidity (long term) classified after Clavien-Dindo.
Time frame: 30 days (until 31st postoperative day)
30-day morbidity will be detailed assessed. Grade 3 or above morbidity rate will be assessed.
30-day mortality
Time frame: 30 days postoperative
30-day mortality of each patient will be recorded.
90-day mortality
Time frame: 90 days postoperative
90-day mortality of each patient will be recorded.
Change in preoperative functional status - 6MWD by operation
Time frame: Measured points: 4 weeks before surgery, on day of hospital admission
6MWD (6-minute walking distance test)
Change in postoperative functional status - 6MWD by the end of rehabilitation
Time frame: Measured points: 4 weeks before surgery, 8 weeks after operation
6MWD (6-minute walking distance test)
Change in preoperative functional status - FVC by operation
Time frame: Measured points: 4 weeks before surgery, on day of hospital admission
FVC (forced vital capacity) will be measured.
Change in preoperative functional status - FVC by the end of rehabilitation
Time frame: Measured points: 4 weeks before surgery, 8 weeks after operation
FVC (forced vital capacity) will be measured.
1 secondary outcome
Delay in beginning of adjuvant oncotherapy (chemotherapy, radiotherapy).
Time frame: within 8 weeks, if adjuvant oncotherapy is needed
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 17 Mar 2020.
- Background: PubMed 30266205Souwer ETD, Bastiaannet E, de Bruijn S, Breugom AJ, van den Bos F, Portielje JEA, Dekker JWT. Comprehensive multidisciplinary care program for elderly colorectal cancer patients: "From prehabilitation to independence". Eur J Surg Oncol. 2018 Dec;44(12):1894-1900. doi: 10.1016/j.ejso.2018.08.028. Epub 2018 Sep 8.
- Background: PubMed 29327644Bousquet-Dion G, Awasthi R, Loiselle SE, Minnella EM, Agnihotram RV, Bergdahl A, Carli F, Scheede-Bergdahl C. Evaluation of supervised multimodal prehabilitation programme in cancer patients undergoing colorectal resection: a randomized control trial. Acta Oncol. 2018 Jun;57(6):849-859. doi: 10.1080/0284186X.2017.1423180. Epub 2018 Jan 12.
- Background: PubMed 27539131Chen BP, Awasthi R, Sweet SN, Minnella EM, Bergdahl A, Santa Mina D, Carli F, Scheede-Bergdahl C. Four-week prehabilitation program is sufficient to modify exercise behaviors and improve preoperative functional walking capacity in patients with colorectal cancer. Support Care Cancer. 2017 Jan;25(1):33-40. doi: 10.1007/s00520-016-3379-8. Epub 2016 Aug 18.
- Background: PubMed 27913000Carli F, Silver JK, Feldman LS, McKee A, Gilman S, Gillis C, Scheede-Bergdahl C, Gamsa A, Stout N, Hirsch B. Surgical Prehabilitation in Patients with Cancer: State-of-the-Science and Recommendations for Future Research from a Panel of Subject Matter Experts. Phys Med Rehabil Clin N Am. 2017 Feb;28(1):49-64. doi: 10.1016/j.pmr.2016.09.002.
- Background: PubMed 29536753Banky B, Lakatos M, Varga K, Hansagi E, Horvath E, Jaray G. [Enhanced Recovery Program in colorectal surgery]. Magy Seb. 2018 Mar;71(1):3-11. doi: 10.1556/1046.71.2018.1.1. Hungarian.
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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.
Balázs Bánky, PhD study director
Department of Surgery, St. Borbala Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation + ERAS and ERAS in people with Colorectal Cancer and Insulin Resistance, run by St. Borbala Hospital at 1 site in Hungary.
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: finished, as of the sponsor's last update on 17 Mar 2020. 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 Hungary. 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?
Length of hospital stay (time frame: within 45 days). The study lists 10 primary outcomes in all. 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 NCT03758209, which also lists 5 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 17 Mar 2020.