Gynecologic SurgeryNCT03828981
A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy
A study testing fast-track recovery program in people with Gynecologic Surgery, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Factors affecting to length of hospital stay after fast-track recovery program in laparoscopic hysterectomy compared to conventional recovery program Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Surgery
- What is being tested?
- fast-track recovery program
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- 31 May 2016to 30 May 2018
- 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 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- uterine size less than uterine size at 14 weeks of pregnancy
- at list one friend or family available to care to care after discharge.
Who cannot join
- endometriosis
- contraindications to any of medications used in the study (oxycodone, ketoprofen, or paracetamol)
- language difficulties (inability to understand and speak Finnish or Swedish)
- age older that 70 years
- mental health disability that limit autonomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy.
Factors affecting to length of hospital stay after fast-track recovery program in laparoscopic hysterectomy compared to conventional recovery program
Read the detailed description
Factors affecting to length of hospital stay after laparoscopic hysterectomy in fast-track recovery program group compared to conventional recovery group.
The pimary outcome is time to discharge from the end of operation to discharge.
The second outcomes are amount of opioid used and NSAID, postoperative paine, nousea and vomiting, patients satisfaction, anxiety and stress-coping test, operative bleeding, operative time, postoperative complications, the cost of the laparoscopic hysterectomy.
- Conditions
- Gynecologic Surgery
- Being tested
- fast-track recovery program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fast-track recovery programProcedure or surgery
Pre-operative: fast-track management counseling, fast-track educational video,tobacco cessation, daily physical activity, light meal 6 hours and clear liquids up to 2 hours before surgery, no bowel preparation, a warm blanket, medication.
Intra-operative: vaginal wound infiltrative anesthesia, early remove of urine catheter.
Post-operative: early oral intake liquids and food, early mobilization, avoiding opioids by use of pregabaline for postoperative pain.
| Study group | Role | What they receive |
|---|---|---|
| fast-track recovery program | Active comparator | Pre-operative Verbal and video information Tobacco cessation Daily physical activity Light meal 6 hours and clear liquids up to 2 hours before surgery No bowel preparation A warm blanket Premedication paracetamol 1g and tematsepam 20mg
Intraoperatively For nausea and voimiting dexamethasone 10mg, dehydrobensperidol 1mg and ondancetron 4mg before emergence Analgesia: ropivacain at port sites before incision and at vaginal vault Opioids intravenously at discretion of anesthesiologist supplemented with Dexketoprofen 50mg Urinary catheter early removal Postoperative Pain: tramadol 50mg and ketoprofen100mg i.v., oral opioid if needed; patients with normal pain control receive oral pregabalin 25mg every 8 hours, paracetamol 1000mg every 8 hours, ibuprofen 600mg every 8 hours until discharge Out of bed after 2 hours from the end of surgery A liquid diet, if tolerated regular normal diet. For emesis ondansetron 4mg Receives: Procedure: fast-track recovery program |
| conventional recovery program | No intervention | Preoperative preparation Verbal and written information Cessation of oral intake after previous midnight. Premedication paracetamol 1g+ diatsepam 5mg. Intraoperative A warm blanket at the start of procedure. Prophylaxis for nausea and vomiting: Dexamethasone 5mg at induction, and Dehydrobenzperidol 1mg, ondancetron 4mg before emergence. Analgesia: injection of ropivacain 5% 20ml at port sites at the end of surgery, Opioids i.v. (oxycodone) Postoperative Pain medication:Opioids i.v. (oxycodone), paracetamol 1000mg every 8 hours, ibuprofen 600mg every 8 hours Urinary catheter removal on next morning. Prolonged bowel and bed rest and gradual reintroduction of feeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of hospitalisation
time from end of operation until discharge
Measured: up to one week
Secondary outcomes (8)
postoperative pain score
Visual analog score (VAS) for pain. The scale is from 0 to 10. 0 is no pain and 10 is worst imaginable pain.
Measured: change in 24 hours after surgery
nausea
Visual analog score (VAS) for nausea. the scale is from 0 to 10. 0 is no nausea and 10 is worst imaginable nausea.
Measured: change in 24 hours after surgery
vomiting
Visual analog score (VAS) for vomiting. The scale is from 0 to 10. 0 is no vomiting and 10 is worst imaginable vomiting´.
Measured: change in 24 hours after surgery
complications
Frequency of complications.Values are given as n (%) and eventual complications are spesified.
Measured: Up to one week.
The use of anelgesics for posoperative pain.
Postoperative pain defined as total amount (mg) of analgesics used. Amount of use oxycodone (mg).
Measured: change in 24 hours after surgery
Patient quality of life
Measurement quality of life by questionnaire 15D
Measured: 1 month before the surgery, in the morning of surgery day and one month after surgery
Patient subjective psychological stress level by general health questionnaire(GHQ12)
Measurement of psychological stress
Measured: 1 month before the surgery, in the morning of surgery day and one month after surgery
patient quality of life
Measurement quality of life by questionnaires WHOQO-BREF
Measured: 1 month before the surgery, in the morning of surgery day and one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start31 May 2016
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Gynecologic SurgeryStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- 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
- randomized superiority trial
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Päivi Päkarinen, Helsinki University Central Hospital
- Investigators
- Olga Kilpiö, MD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828981
- Sponsor's protocol ID
- Unique Protocol ID: 98/13/03/0
- Status last verified
- Feb 2019
- First submitted
- 21 Jan 2019
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share a data
Publications
Borendal Wodlin N, Nilsson L, Carlsson P, Kjolhede P. Cost-effectiveness of general anesthesia vs spinal anesthesia in fast-track abdominal benign hysterectomy. Am J Obstet Gynecol. 2011 Oct;205(4):326.e1-7. doi: 10.1016/j.ajog.2011.05.043. Epub 2011 Jun 7.
PubMed 22083055Kjolhede P, Borendal Wodlin N, Nilsson L, Fredrikson M, Wijma K. Impact of stress coping capacity on recovery from abdominal hysterectomy in a fast-track programme: a prospective longitudinal study. BJOG. 2012 Jul;119(8):998-1006; discussion 1006-7. doi: 10.1111/j.1471-0528.2012.03342.x. Epub 2012 May 9.
PubMed 22568450Kjolhede P, Langstrom P, Nilsson P, Wodlin NB, Nilsson L. The impact of quality of sleep on recovery from fast-track abdominal hysterectomy. J Clin Sleep Med. 2012 Aug 15;8(4):395-402. doi: 10.5664/jcsm.2032.
PubMed 22893770Nilsson L, Wodlin NB, Kjolhede P. Risk factors for postoperative complications after fast-track abdominal hysterectomy. Aust N Z J Obstet Gynaecol. 2012 Apr;52(2):113-20. doi: 10.1111/j.1479-828X.2011.01395.x. Epub 2012 Jan 8.
PubMed 22224504Wodlin NB, Nilsson L. The development of fast-track principles in gynecological surgery. Acta Obstet Gynecol Scand. 2013 Jan;92(1):17-27. doi: 10.1111/j.1600-0412.2012.01525.x. Epub 2012 Nov 1.
PubMed 22880948Wodlin NB, Nilsson L, Kjolhede P. [Fast track has its advantages in elective gynecological surgery]. Lakartidningen. 2014 Jun 17-Jul 1;111(25-26):1120-3. No abstract available. Swedish.
PubMed 25072075Wodlin NB, Nilsson L, Kjolhede P. Health-related quality of life and postoperative recovery in fast-track hysterectomy. Acta Obstet Gynecol Scand. 2011 Apr;90(4):362-8. doi: 10.1111/j.1600-0412.2010.01058.x. Epub 2011 Feb 18.
PubMed 21306322Veenhof AA, Vlug MS, van der Pas MH, Sietses C, van der Peet DL, de Lange-de Klerk ES, Bonjer HJ, Bemelman WA, Cuesta MA. Surgical stress response and postoperative immune function after laparoscopy or open surgery with fast track or standard perioperative care: a randomized trial. Ann Surg. 2012 Feb;255(2):216-21. doi: 10.1097/SLA.0b013e31824336e2.
PubMed 22241289Wijk L, Franzen K, Ljungqvist O, Nilsson K. Implementing a structured Enhanced Recovery After Surgery (ERAS) protocol reduces length of stay after abdominal hysterectomy. Acta Obstet Gynecol Scand. 2014 Aug;93(8):749-56. doi: 10.1111/aogs.12423. Epub 2014 Jun 13.
PubMed 24828471van Bree SH, Vlug MS, Bemelman WA, Hollmann MW, Ubbink DT, Zwinderman AH, de Jonge WJ, Snoek SA, Bolhuis K, van der Zanden E, The FO, Bennink RJ, Boeckxstaens GE. Faster recovery of gastrointestinal transit after laparoscopy and fast-track care in patients undergoing colonic surgery. Gastroenterology. 2011 Sep;141(3):872-880.e1-4. doi: 10.1053/j.gastro.2011.05.034. Epub 2011 May 26.
PubMed 21699777Vlug MS, Wind J, Hollmann MW, Ubbink DT, Cense HA, Engel AF, Gerhards MF, van Wagensveld BA, van der Zaag ES, van Geloven AA, Sprangers MA, Cuesta MA, Bemelman WA; LAFA study group. Laparoscopy in combination with fast track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: a randomized clinical trial (LAFA-study). Ann Surg. 2011 Dec;254(6):868-75. doi: 10.1097/SLA.0b013e31821fd1ce.
PubMed 21597360Relph S, Bell A, Sivashanmugarajan V, Munro K, Chigwidden K, Lloyd S, Fakokunde A, Yoong W. Cost effectiveness of enhanced recovery after surgery programme for vaginal hysterectomy: a comparison of pre and post-implementation expenditures. Int J Health Plann Manage. 2014 Oct-Dec;29(4):399-406. doi: 10.1002/hpm.2182. Epub 2013 May 10.
PubMed 23661616Rhou YJ, Pather S, Loadsman JA, Campbell N, Philp S, Carter J. Direct hospital costs of total laparoscopic hysterectomy compared with fast-track open hysterectomy at a tertiary hospital: a retrospective case-controlled study. Aust N Z J Obstet Gynaecol. 2015 Dec;55(6):584-7. doi: 10.1111/ajo.12093. Epub 2013 May 2.
PubMed 23634987Minig L, Chuang L, Patrono MG, Fernandez-Chereguini M, Cardenas-Rebollo JM, Biffi R. Clinical outcomes after fast-track care in women undergoing laparoscopic hysterectomy. Int J Gynaecol Obstet. 2015 Dec;131(3):301-4. doi: 10.1016/j.ijgo.2015.06.034. Epub 2015 Sep 8.
PubMed 26386495Feroci F, Lenzi E, Baraghini M, Garzi A, Vannucchi A, Cantafio S, Scatizzi M. Fast-track surgery in real life: how patient factors influence outcomes and compliance with an enhanced recovery clinical pathway after colorectal surgery. Surg Laparosc Endosc Percutan Tech. 2013 Jun;23(3):259-65. doi: 10.1097/SLE.0b013e31828ba16f.
PubMed 23751989
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy.
- ClinicalTrials.gov ID
- NCT03828981
- Acronym / sponsor ID
- Unique Protocol ID: 98/13/03/0
- Conditions
- Gynecologic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 31 May 2016 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 4 Feb 2019 (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.
Factors affecting to length of hospital stay after fast-track recovery program in laparoscopic hysterectomy compared to conventional recovery program
Detailed description
Factors affecting to length of hospital stay after laparoscopic hysterectomy in fast-track recovery program group compared to conventional recovery group.
The pimary outcome is time to discharge from the end of operation to discharge.
The second outcomes are amount of opioid used and NSAID, postoperative paine, nousea and vomiting, patients satisfaction, anxiety and stress-coping test, operative bleeding, operative time, postoperative complications, the cost of the laparoscopic hysterectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized superiority trial
| Arm | Type | Receives |
|---|---|---|
| fast-track recovery program | Active comparator | Procedure: fast-track recovery programPre-operative Verbal and video information Tobacco cessation Daily physical activity Light meal 6 hours and clear liquids up to 2 hours before surgery No bowel preparation A warm blanket Premedication paracetamol 1g and tematsepam 20mg Intraoperatively For nausea and voimiting dexamethasone 10mg, dehydrobensperidol 1mg and ondancetron 4mg before emergence Analgesia: ropivacain at port sites before incision and at vaginal vault Opioids intravenously at discretion of anesthesiologist supplemented with Dexketoprofen 50mg Urinary catheter early removal Postoperative Pain: tramadol 50mg and ketoprofen100mg i.v., oral opioid if needed; patients with normal pain control receive oral pregabalin 25mg every 8 hours, paracetamol 1000mg every 8 hours, ibuprofen 600mg every 8 hours until discharge Out of bed after 2 hours from the end of surgery A liquid diet, if tolerated regular normal diet. For emesis ondansetron 4mg |
| conventional recovery program | No intervention | –Preoperative preparation Verbal and written information Cessation of oral intake after previous midnight. Premedication paracetamol 1g+ diatsepam 5mg. Intraoperative A warm blanket at the start of procedure. Prophylaxis for nausea and vomiting: Dexamethasone 5mg at induction, and Dehydrobenzperidol 1mg, ondancetron 4mg before emergence. Analgesia: injection of ropivacain 5% 20ml at port sites at the end of surgery, Opioids i.v. (oxycodone) Postoperative Pain medication:Opioids i.v. (oxycodone), paracetamol 1000mg every 8 hours, ibuprofen 600mg every 8 hours Urinary catheter removal on next morning. Prolonged bowel and bed rest and gradual reintroduction of feeding. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- uterine size less than uterine size at 14 weeks of pregnancy
- at list one friend or family available to care to care after discharge.
Key exclusion criteria (5 listed)
- endometriosis
- contraindications to any of medications used in the study (oxycodone, ketoprofen, or paracetamol)
- language difficulties (inability to understand and speak Finnish or Swedish)
- age older that 70 years
- mental health disability that limit autonomy
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 |
|---|---|---|
| fast-track recovery programPre-operative: fast-track management counseling, fast-track educational video,tobacco cessation, daily physical activity, light meal 6 hours and clear liquids up to 2 hours before surgery, no bowel preparation, a warm blanket, medication. Intra-operative: vaginal wound infiltrative anesthesia, early remove of urine catheter. Post-operative: early oral intake liquids and food, early mobilization, avoiding opioids by use of pregabaline for postoperative pain. | Procedure or surgery | fast-track recovery program |
Primary outcome
length of hospitalisation
Time frame: up to one week
time from end of operation until discharge
8 secondary outcomes
postoperative pain score
Time frame: change in 24 hours after surgery
nausea
Time frame: change in 24 hours after surgery
vomiting
Time frame: change in 24 hours after surgery
complications
Time frame: Up to one week.
The use of anelgesics for posoperative pain.
Time frame: change in 24 hours after surgery
Patient quality of life
Time frame: 1 month before the surgery, in the morning of surgery day and one month after surgery
Patient subjective psychological stress level by general health questionnaire(GHQ12)
Time frame: 1 month before the surgery, in the morning of surgery day and one month after surgery
patient quality of life
Time frame: 1 month before the surgery, in the morning of surgery day and one month 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 4 Feb 2019.
- Background: PubMed 22083055Borendal Wodlin N, Nilsson L, Carlsson P, Kjolhede P. Cost-effectiveness of general anesthesia vs spinal anesthesia in fast-track abdominal benign hysterectomy. Am J Obstet Gynecol. 2011 Oct;205(4):326.e1-7. doi: 10.1016/j.ajog.2011.05.043. Epub 2011 Jun 7.
- Background: PubMed 22568450Kjolhede P, Borendal Wodlin N, Nilsson L, Fredrikson M, Wijma K. Impact of stress coping capacity on recovery from abdominal hysterectomy in a fast-track programme: a prospective longitudinal study. BJOG. 2012 Jul;119(8):998-1006; discussion 1006-7. doi: 10.1111/j.1471-0528.2012.03342.x. Epub 2012 May 9.
- Background: PubMed 22893770Kjolhede P, Langstrom P, Nilsson P, Wodlin NB, Nilsson L. The impact of quality of sleep on recovery from fast-track abdominal hysterectomy. J Clin Sleep Med. 2012 Aug 15;8(4):395-402. doi: 10.5664/jcsm.2032.
- Background: PubMed 22224504Nilsson L, Wodlin NB, Kjolhede P. Risk factors for postoperative complications after fast-track abdominal hysterectomy. Aust N Z J Obstet Gynaecol. 2012 Apr;52(2):113-20. doi: 10.1111/j.1479-828X.2011.01395.x. Epub 2012 Jan 8.
- Background: PubMed 22880948Wodlin NB, Nilsson L. The development of fast-track principles in gynecological surgery. Acta Obstet Gynecol Scand. 2013 Jan;92(1):17-27. doi: 10.1111/j.1600-0412.2012.01525.x. Epub 2012 Nov 1.
- Background: PubMed 25072075Wodlin NB, Nilsson L, Kjolhede P. [Fast track has its advantages in elective gynecological surgery]. Lakartidningen. 2014 Jun 17-Jul 1;111(25-26):1120-3. No abstract available. Swedish.
- Background: PubMed 21306322Wodlin NB, Nilsson L, Kjolhede P. Health-related quality of life and postoperative recovery in fast-track hysterectomy. Acta Obstet Gynecol Scand. 2011 Apr;90(4):362-8. doi: 10.1111/j.1600-0412.2010.01058.x. Epub 2011 Feb 18.
- Background: PubMed 22241289Veenhof AA, Vlug MS, van der Pas MH, Sietses C, van der Peet DL, de Lange-de Klerk ES, Bonjer HJ, Bemelman WA, Cuesta MA. Surgical stress response and postoperative immune function after laparoscopy or open surgery with fast track or standard perioperative care: a randomized trial. Ann Surg. 2012 Feb;255(2):216-21. doi: 10.1097/SLA.0b013e31824336e2.
- Background: PubMed 24828471Wijk L, Franzen K, Ljungqvist O, Nilsson K. Implementing a structured Enhanced Recovery After Surgery (ERAS) protocol reduces length of stay after abdominal hysterectomy. Acta Obstet Gynecol Scand. 2014 Aug;93(8):749-56. doi: 10.1111/aogs.12423. Epub 2014 Jun 13.
- Background: PubMed 21699777van Bree SH, Vlug MS, Bemelman WA, Hollmann MW, Ubbink DT, Zwinderman AH, de Jonge WJ, Snoek SA, Bolhuis K, van der Zanden E, The FO, Bennink RJ, Boeckxstaens GE. Faster recovery of gastrointestinal transit after laparoscopy and fast-track care in patients undergoing colonic surgery. Gastroenterology. 2011 Sep;141(3):872-880.e1-4. doi: 10.1053/j.gastro.2011.05.034. Epub 2011 May 26.
- Background: PubMed 21597360Vlug MS, Wind J, Hollmann MW, Ubbink DT, Cense HA, Engel AF, Gerhards MF, van Wagensveld BA, van der Zaag ES, van Geloven AA, Sprangers MA, Cuesta MA, Bemelman WA; LAFA study group. Laparoscopy in combination with fast track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: a randomized clinical trial (LAFA-study). Ann Surg. 2011 Dec;254(6):868-75. doi: 10.1097/SLA.0b013e31821fd1ce.
- Background: PubMed 23661616Relph S, Bell A, Sivashanmugarajan V, Munro K, Chigwidden K, Lloyd S, Fakokunde A, Yoong W. Cost effectiveness of enhanced recovery after surgery programme for vaginal hysterectomy: a comparison of pre and post-implementation expenditures. Int J Health Plann Manage. 2014 Oct-Dec;29(4):399-406. doi: 10.1002/hpm.2182. Epub 2013 May 10.
- Individual participant dataSharing planned: No. no plan to share a data
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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.
Olga Kilpiö, MD study director
Helsinki University Central 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 fast-track recovery program in people with Gynecologic Surgery, run by Helsinki University Central Hospital at 1 site in Finland.
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 2 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 4 Feb 2019. 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 Finland. 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 hospitalisation (time frame: up to one week). 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 NCT03828981, which also lists 20 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 4 Feb 2019.