Thoracic SurgeryNCT03503565
Intraoperative Neuromuscular Blockade and Postoperative Atelectasis
An observational study of Thoracic Surgery and One-lung Ventilation, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.
Trial summary
During one-lung ventilation in thoracic surgery, the intensity of neuromuscular blockade may change the compliance and resistance of ventilated lung, thereby affecting postoperative atelectasis. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Thoracic Surgery, One-lung Ventilation
- What is being tested?
- intraoperative neuromuscular blockade
- Type of treatment
- Surgery or procedure
- How many people
- 118 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Oct 2018to 18 May 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving open or thoracoscopic lobectomy, bi-lobectomy, or sleeve lobectomy.
Who may be able to join
- Patients receiving scheduled unilateral lung lobectomy.
- Patients age ≥19
- Patients of American Society of Anesthesiologist Physical Status 1 or 2
Who cannot join
- Patients receiving bilateral lung lobectomy
- Patients BMI > 35.0 or < 18.5 kg/m2
- Patients of contraindicated to epidural patients controlled analgesia
- Patients with neuromuscular disease (i.e. myasthenia gravis)
- Patients with major burn (more than 3rd degrees)
- Patients with compromised cardiopulmonary function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intraoperative Neuromuscular Blockade on Postoperative Atelectasis in Patients Undergoing Thoracic Surgery With One Lung Ventilation: Moderate vs. Deep Block
During one-lung ventilation in thoracic surgery, the intensity of neuromuscular blockade may change the compliance and resistance of ventilated lung, thereby affecting postoperative atelectasis. The present study investigated the effect of the intensity of intraoperative neuromuscular blockade on the postoperative atelectasis using chest computerized tomography in patients receiving thoracic surgery requiring one-lung ventilation.
Read the detailed description
Neuromuscular blocking agents can be used to secure a good surgical field, but it can also cause delayed extubation or postoperative pulmonary complications. Traditionally, rocuronium which is a commonly used non-depolarizing agent is usually reversed by cholinesterase inhibitors such as neostigmine or pyridostigmine. These drugs act by increasing the concentration of acetylcholine at the neuromuscular junction (a competing antagonist), not by direct antagonists. Consequently, there is a risk of pulmonary complications when cholinesterase inhibitor is not used appropriately. Use of sugammadex can reverse neuromuscular blockade (NMB) quickly, thereby being helpful for spontaneous deep breathing postoperatively. In a previous study, the moderate neuromuscular blockade was not guaranteed during surgery because intraoperative train-of-four (TOF) monitoring was not used and the outcome was focused on the correlation between reversal agent and the overall incidence of postoperative pulmonary complications. However, in the present study, TOF ratio or post-tetanic count (PTC) was repeatedly measured during surgery, thereby the intensity of intraoperative NMB being maintained. Moreover, lung compliance was repeatedly measured during surgery and the correlation between the intensity of intraoperative NMB and postoperative atelectasis which is evaluated by quantitative technique was also investigated.
Particularly in thoracic surgery, one lung ventilation is usually required for the surgical procedure. During one-lung ventilation, the compliance of ventilated lung is decreased and resistance can be increased, thereby the risk of atelectasis being increased. Furthermore, after thoracic surgery, although patients were encouraged to deep breathe, it is difficult to take a deep breath because of various factors. (i.e. pain, chest tube, long retracted time, postoperative interstitial edema, etc.) Therefore, postoperative atelectasis is much more important in patients undergoing thoracic surgery than other types of surgery.
For preventing postoperative atelectasis, the intraoperative intensity of neuromuscular blockade can be a crucial factor. Because deep neuromuscular blockade provides a good lung compliance during mechanical ventilation, peak inspiratory pressure can be decreased, thereby reducing the risk of ventilation-induced lung injury, particularly in one lung ventilation situation.However, there has been still lack of quantitative evidence that deep block is superior to moderate block in the thoracic surgery with one-lung ventilation
For assessment of postoperative atelectasis, plain chest radiography may be used. However, plain chest radiography can provide only a qualitative assessment of atelectasis. Computed tomography can assess the whole lung by its density (HU) and enables a quantitative assessment of postoperative atelectasis. Moreover, it can indicate the location of atelectasis more clearly than plain chest radiography, thus provide detailed information about postoperative lung state. To assess the effect of maintaining deep block and sugammadex reversal on the postoperative atelectasis, using chest CT can provide a much more quantitative and valuable information than conventional chest radiography.
- Conditions
- Thoracic Surgery, One-lung Ventilation
- Being tested
- intraoperative neuromuscular blockade
- Keywords
- one-lung ventilation, thoracic surgery, atelectasis, postoperative pulmonary complication
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative neuromuscular blockadeProcedure or surgery
The intensity of intraoperative neuromuscular blockade
| Study group | Role | What they receive |
|---|---|---|
| Moderate block group | maintaining moderate intraoperative neuromuscular blockade (TOF count 1 or 2) during surgery and reversal using sugammadex 2 mg/kg after surgery Receives: Procedure: intraoperative neuromuscular blockade | |
| Deep block group | maintaining deep intraoperative neuromuscular blockade (PTC 1 or 2) during surgery and reversal using sugammadex 4 mg/kg after surgery Receives: Procedure: intraoperative neuromuscular blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atelectasis Area on Chest CT
Atelectasis on Chest CT The lung area was delineated manually. To calculate atelectasis, a region of interest was laid out that encircled the dense part of the lung, excluding large vessels. For further analysis, the lung was divided into four categories: areas with densities ranging from -1000 to -900 Hounsfield units (HU) were classified as over-aerated, from -900 to -500 HU as normally aerated, from -500 to -100 HU as poorly aerated, and from -100 to +100 HU as non-aerated (atelectasis). The proportion of non-aerated lung tissue (-100 to +100 HU) was calculated by dividing the area of the region of interest with the whole lungs.
Measured: 1 day after the end of surgery
Secondary outcomes (7)
Number of Patients Defined as Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome can be defined as follows;
Bilateral opacities not fully explained by effusions, lobar/lung collapse or nodules on chest radiograph or CT scan and Respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (e.g. echocardiography) to exclude hydrostatic edema if no risk factor present and Partial pressure of pulmonary arterial oxygen / Oxygen friction < 300 mmHg with positive end-expiratory pressure or continuous positive airway pressure of 5 cmH2O.
Measured: up to 7 days after the end of surgery
Number of Patients Defined as Pneumonia
Pneumonia can be defined as follows;
Two or more serial chest radiographs with at least one of the following (one radiograph is sufficient for patients with no underlying pulmonary or cardiac disease):
- new or progressive and persistent infiltrates
- consolidation
- cavitation; at least one of the following
- fever (>38.0 C) with no other recognized cause 2) White blood cell count < 4000/ml or >12,000/ml 3) for adults >70 yr, altered mental status with no other recognized cause; and at least two of the following
- new onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements
- new onset or worsening cough, or dyspnea, or tachypnea
- crackles or bronchial breath sounds
- worsening gas exchange (hypoxaemia, increased oxygen requirement, increased ventilator demand).
Measured: up to 7 days after the end of surgery
Number of Patients Showing Pleural Effusion
Pleural effusion can be diagnosed on postoperative radiograph imaging.
Measured: 1 day after the end of surgery
Number of Patients Showing Postoperative Desaturation
The number of patients showing desaturation (SpO2 <95%) in room air.
Measured: up to 1 day after surgery completed
Number of Patients Requiring Postoperative Re-intubation
The number of patients requiring re-intubation due to postoperative respiratory difficulty.
Measured: up to 1 day after surgery completed
Intraoperative Lung Compliance (ml/cmH2O)
Intraoperative lung compliance (ml/cmH2O) can be calculated with peak inspiratory pressure or plateau pressure, positive end-expiratory pressure and tidal volume.
Measured: every 1 hour from the time of the tracheal intubation to the end of the skin closure.
Patient Demographic Data
Age in years, Gender, Weight in kilograms, Height in centimeters
Measured: on the day of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start11 Oct 2018
- Primary completion14 May 2020
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Thoracic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyung Hee University Hospital at Gangdong
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Hyungseok Seo, Kyung Hee University Hospital at Gangdong
- Investigators
- Hyungseok Seo, MD, PhD, Principal investigator, Kyung Hee University Hospital at Gangdong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503565
- Sponsor's protocol ID
- 2018-03-015
- Status last verified
- Aug 2021
- First submitted
- 6 Apr 2018
- Last updated
- 20 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho HC, Lee JH, Lee SC, Park SY, Rim JC, Choi SR. Use of sugammadex in lung cancer patients undergoing video-assisted thoracoscopic lobectomy. Korean J Anesthesiol. 2017 Aug;70(4):420-425. doi: 10.4097/kjae.2017.70.4.420. Epub 2017 Apr 21.
PubMed 28794837Grosse-Sundrup M, Henneman JP, Sandberg WS, Bateman BT, Uribe JV, Nguyen NT, Ehrenfeld JM, Martinez EA, Kurth T, Eikermann M. Intermediate acting non-depolarizing neuromuscular blocking agents and risk of postoperative respiratory complications: prospective propensity score matched cohort study. BMJ. 2012 Oct 15;345:e6329. doi: 10.1136/bmj.e6329.
PubMed 23077290Bulka CM, Terekhov MA, Martin BJ, Dmochowski RR, Hayes RM, Ehrenfeld JM. Nondepolarizing Neuromuscular Blocking Agents, Reversal, and Risk of Postoperative Pneumonia. Anesthesiology. 2016 Oct;125(4):647-55. doi: 10.1097/ALN.0000000000001279.
PubMed 27496656Casanova J, Pineiro P, De La Gala F, Olmedilla L, Cruz P, Duque P, Garutti I. [Deep versus moderate neuromuscular block during one-lung ventilation in lung resection surgery]. Rev Bras Anestesiol. 2017 May-Jun;67(3):288-293. doi: 10.1016/j.bjan.2017.02.005. Epub 2017 Feb 27. Portuguese.
PubMed 28256331Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb.
PubMed 19809292Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.
PubMed 25058504
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Neuromuscular Blockade on Postoperative Atelectasis in Patients Undergoing Thoracic Surgery With One Lung Ventilation: Moderate vs. Deep Block
- ClinicalTrials.gov ID
- NCT03503565
- Acronym / sponsor ID
- 2018-03-015
- Conditions
- Thoracic Surgery, One-lung Ventilation
- Keywords
- one-lung ventilation, thoracic surgery, atelectasis, postoperative pulmonary complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Kyung Hee University Hospital at GangdongUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Posted 20 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During one-lung ventilation in thoracic surgery, the intensity of neuromuscular blockade may change the compliance and resistance of ventilated lung, thereby affecting postoperative atelectasis. The present study investigated the effect of the intensity of intraoperative neuromuscular blockade on the postoperative atelectasis using chest computerized tomography in patients receiving thoracic surgery requiring one-lung ventilation.
Detailed description
Neuromuscular blocking agents can be used to secure a good surgical field, but it can also cause delayed extubation or postoperative pulmonary complications. Traditionally, rocuronium which is a commonly used non-depolarizing agent is usually reversed by cholinesterase inhibitors such as neostigmine or pyridostigmine. These drugs act by increasing the concentration of acetylcholine at the neuromuscular junction (a competing antagonist), not by direct antagonists. Consequently, there is a risk of pulmonary complications when cholinesterase inhibitor is not used appropriately. Use of sugammadex can reverse neuromuscular blockade (NMB) quickly, thereby being helpful for spontaneous deep breathing postoperatively. In a previous study, the moderate neuromuscular blockade was not guaranteed during surgery because intraoperative train-of-four (TOF) monitoring was not used and the outcome was focused on the correlation between reversal agent and the overall incidence of postoperative pulmonary complications. However, in the present study, TOF ratio or post-tetanic count (PTC) was repeatedly measured during surgery, thereby the intensity of intraoperative NMB being maintained. Moreover, lung compliance was repeatedly measured during surgery and the correlation between the intensity of intraoperative NMB and postoperative atelectasis which is evaluated by quantitative technique was also investigated.
Particularly in thoracic surgery, one lung ventilation is usually required for the surgical procedure. During one-lung ventilation, the compliance of ventilated lung is decreased and resistance can be increased, thereby the risk of atelectasis being increased. Furthermore, after thoracic surgery, although patients were encouraged to deep breathe, it is difficult to take a deep breath because of various factors. (i.e. pain, chest tube, long retracted time, postoperative interstitial edema, etc.) Therefore, postoperative atelectasis is much more important in patients undergoing thoracic surgery than other types of surgery.
For preventing postoperative atelectasis, the intraoperative intensity of neuromuscular blockade can be a crucial factor. Because deep neuromuscular blockade provides a good lung compliance during mechanical ventilation, peak inspiratory pressure can be decreased, thereby reducing the risk of ventilation-induced lung injury, particularly in one lung ventilation situation.However, there has been still lack of quantitative evidence that deep block is superior to moderate block in the thoracic surgery with one-lung ventilation
For assessment of postoperative atelectasis, plain chest radiography may be used. However, plain chest radiography can provide only a qualitative assessment of atelectasis. Computed tomography can assess the whole lung by its density (HU) and enables a quantitative assessment of postoperative atelectasis. Moreover, it can indicate the location of atelectasis more clearly than plain chest radiography, thus provide detailed information about postoperative lung state. To assess the effect of maintaining deep block and sugammadex reversal on the postoperative atelectasis, using chest CT can provide a much more quantitative and valuable information than conventional chest radiography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate block group | – | Procedure: intraoperative neuromuscular blockademaintaining moderate intraoperative neuromuscular blockade (TOF count 1 or 2) during surgery and reversal using sugammadex 2 mg/kg after surgery |
| Deep block group | – | Procedure: intraoperative neuromuscular blockademaintaining deep intraoperative neuromuscular blockade (PTC 1 or 2) during surgery and reversal using sugammadex 4 mg/kg after surgery |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving open or thoracoscopic lobectomy, bi-lobectomy, or sleeve lobectomy.
Key inclusion criteria (3 listed)
- Patients receiving scheduled unilateral lung lobectomy.
- Patients age ≥19
- Patients of American Society of Anesthesiologist Physical Status 1 or 2
Key exclusion criteria (6 listed)
- Patients receiving bilateral lung lobectomy
- Patients BMI > 35.0 or < 18.5 kg/m2
- Patients of contraindicated to epidural patients controlled analgesia
- Patients with neuromuscular disease (i.e. myasthenia gravis)
- Patients with major burn (more than 3rd degrees)
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 |
|---|---|---|
| intraoperative neuromuscular blockadeThe intensity of intraoperative neuromuscular blockade | Procedure or surgery | Deep block group, Moderate block group |
Primary outcome
Atelectasis Area on Chest CT
Time frame: 1 day after the end of surgery
Atelectasis on Chest CT The lung area was delineated manually. To calculate atelectasis, a region of interest was laid out that encircled the dense part of the lung, excluding large vessels. For further analysis, the lung was divided into four categories: areas with densities ranging from -1000 to -900 Hounsfield units (HU) were classified as over-aerated, from -900 to -500 HU as normally aerated, from -500 to -100 HU as poorly aerated, and from -100 to +100 HU as non-aerated (atelectasis). The proportion of non-aerated lung tissue (-100 to +100 HU) was calculated by dividing the area of the region of interest with the whole lungs.
7 secondary outcomes
Number of Patients Defined as Acute Respiratory Distress Syndrome
Time frame: up to 7 days after the end of surgery
Number of Patients Defined as Pneumonia
Time frame: up to 7 days after the end of surgery
Number of Patients Showing Pleural Effusion
Time frame: 1 day after the end of surgery
Number of Patients Showing Postoperative Desaturation
Time frame: up to 1 day after surgery completed
Number of Patients Requiring Postoperative Re-intubation
Time frame: up to 1 day after surgery completed
Intraoperative Lung Compliance (ml/cmH2O)
Time frame: every 1 hour from the time of the tracheal intubation to the end of the skin closure.
Patient Demographic Data
Time frame: on the day of admission
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28794837Cho HC, Lee JH, Lee SC, Park SY, Rim JC, Choi SR. Use of sugammadex in lung cancer patients undergoing video-assisted thoracoscopic lobectomy. Korean J Anesthesiol. 2017 Aug;70(4):420-425. doi: 10.4097/kjae.2017.70.4.420. Epub 2017 Apr 21.
- Background: PubMed 23077290Grosse-Sundrup M, Henneman JP, Sandberg WS, Bateman BT, Uribe JV, Nguyen NT, Ehrenfeld JM, Martinez EA, Kurth T, Eikermann M. Intermediate acting non-depolarizing neuromuscular blocking agents and risk of postoperative respiratory complications: prospective propensity score matched cohort study. BMJ. 2012 Oct 15;345:e6329. doi: 10.1136/bmj.e6329.
- Background: PubMed 27496656Bulka CM, Terekhov MA, Martin BJ, Dmochowski RR, Hayes RM, Ehrenfeld JM. Nondepolarizing Neuromuscular Blocking Agents, Reversal, and Risk of Postoperative Pneumonia. Anesthesiology. 2016 Oct;125(4):647-55. doi: 10.1097/ALN.0000000000001279.
- Background: PubMed 28256331Casanova J, Pineiro P, De La Gala F, Olmedilla L, Cruz P, Duque P, Garutti I. [Deep versus moderate neuromuscular block during one-lung ventilation in lung resection surgery]. Rev Bras Anestesiol. 2017 May-Jun;67(3):288-293. doi: 10.1016/j.bjan.2017.02.005. Epub 2017 Feb 27. Portuguese.
- Background: PubMed 19809292Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb.
- Background: PubMed 25058504Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.
- 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.
Hyungseok Seo, MD, PhD principal investigator
Kyung Hee University Hospital at Gangdong
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 Thoracic Surgery and One-lung Ventilation, run by Kyung Hee University Hospital at Gangdong at 1 site in South Korea.
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 3 inclusion and 6 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 20 Aug 2021. 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 20 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Atelectasis Area on Chest CT (time frame: 1 day after the end of surgery). 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 NCT03503565, which also lists 6 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 20 Aug 2021.