Lung DiseasesPhase 4NCT03905837
Impact of Lidocaine Administration on Postoperative Complications During Lung Resection Surgery
A Phase 4 study testing Lidocaine and Remifentanil in people with Lung Diseases and Lung Inflammation, run by Francisco Andres de la Gala at 1 site in Spain.
Trial summary
The purpose of this study is to analyze the impact of the intravenous (IV) or paravertebral (PV) lidocaine administration during the intraoperative period of lung resection surgery on the appearance of postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Lung Inflammation, Lung Injury, Acute
- What is being tested?
- Lidocaine and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteSpain
- Study dates
- 28 Jan 2019to 2 Jul 2021
- Phase
- Phase 4
- 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
- Patients of both sexes undergoing lung resection surgery at the Thoracic Surgery Service at the Gregorio Maranón hospital.
- Patients who voluntarily accept to participate in the study and sign the informed consent
- Age> 18 years and legally capable
- Scheduled surgery.
- Functional respiratory tests with forced expiratory volume at one second > 50% or forced vital capacity > 50% preoperatively performed on these patients routinely.
- Not having been on chronic treatment with oral corticosteroids or immunosuppressants three months before surgery.
- Patients without previous history of liver disease.
Who cannot join
- Pregnancy and lactation
- Known hypersensitivity to amide-type local anesthetics.
- Transfusion of blood products in the previous 10 days.
- Impossibility of performing mechanical ventilation for pulmonary protection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Administration of Intravenous or Paravertebral Lidocaine in Continuous Perfusion During the Intraoperative Period of Lung Resection Surgery on the Appearance of Postoperative Complications
The purpose of this study is to analyze the impact of the intravenous (IV) or paravertebral (PV) lidocaine administration during the intraoperative period of lung resection surgery on the appearance of postoperative complications. We design a randomized, controlled and blinded study to be performed in 153 patients with 3 arms: 1) Lidocaine IV + PV saline 2) saline IV + PV lidocaine, 3) remifentanil IV + PV saline. Perioperative analysis of inflammatory biomarkers in bronchoalveolar lavage and serum. Follow-up of the postoperative course, especially the appearance of postoperative complications according to the revised Clavien-Dindo classification for thoracic surgery, as well as other relevant clinical results.
Read the detailed description
Postoperative pulmonary complications continue to be one of the main causes of morbidity, mortality and increase in hospital stay in patients undergoing surgical procedures requiring anesthesia. Its incidence in lung resection surgery is greater than in other non-cardiac major surgeries due to damage of structures related to respiratory function.
Furthermore, during lung resection surgery there is an exaggerated pulmonary inflammatory response related to the use of one-lung ventilation and / or the lung damage produced by the collapse of the operated lung as well as the surgical manipulation itself.
Recently, in a clinical trial on 180 patients (NCT 02168751), our researcher group observed that the attenuation of the pulmonary inflammatory response through the use of halogenated anesthetic agents, was related to a decrease in the appearance of postoperative pulmonary complications after lung resection surgery. In addition, the presence, in bronchoalveolar lavages, of elevated levels of tumor necrosis factor-alpha, interleukine(IL)-6 and the IL-6 / IL10 ratio were independent predictors of the risk of developing postoperative pulmonary complications.
Lidocaine is a local anesthetic that blocks nerve conduction by blocking sodium channels. In addition it has been known for experimental and clinical studies of its immunomodulatory properties.
Clinical studies performed in different surgeries show that a continuous intravenous infusion of lidocaine during surgery is associated with a lower inflammatory response assessed by monitoring plasma cytokines, as well as less postoperative pain, a shorter duration of postoperative paralytic ileus and a early hospital discharge.
Currently, there is no clinical study that has evaluated the role of intravenous lidocaine on the pulmonary inflammatory response and the subsequent lung damage that inevitably occurs during lung resection surgery with periods of one lung ventilation.
Currently, some experts are proposing the replacement of thoracic epidural and paravertebral analgesia by the intravenous infusion of lidocaine and minor analgesics, for fast-track programs, based on their analgesic and anti-inflammatory capacity and on avoiding the risks inherent in the insertion of an epidural or paravertebral catheter.
Hypothesis: The administration of intravenous or paravertebral lidocaine during lung resection surgery attenuates the exaggerated inflammatory response that inevitably occurs in this surgical intervention. The lower expression of pro-inflammatory mediators will be associated with a lower rate of postoperative complications that are related to the perioperative inflammatory process.
- Being tested
- Lidocaine, Remifentanil
- Keywords
- lidocaine, postoperative complications, thoracic surgery
- Medical subject headings
- Lung Diseases, Pneumonia, Acute Lung Injury, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Lignocaine, N-(2,6-dimethylphenyl)-N2,N2-diethylglycinamide
Intravenous or paravertebral lidocaine
RemifentanilDrug
Also called methyl 1-(2-methoxycarbonylethyl)-4-(phenyl-propanoyl-amino)-piperidine-4-carboxylate
intravenous remifentanil
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine IV | Experimental | Group 1: intravenous lidocaine and paravertebral saline (SF). In this group during intraoperative anesthetic maintenance, a continuous intravenous infusion of lidocaine at 1.5mg/kg/h until the end of surgery and perfusion of 0.9% SF through the intraoperative paravertebral catheter at a rate of 0.1ml/kg/h will be administered. Receives: Drug: Lidocaine |
| Lidocaine PV | Experimental | Group 2: intravenous SF and paravertebral lidocaine. During anesthesia maintenance, a continuous intravenous infusion of 0.9% SF and an infusion of 2% lidocaine will be administered through the intraoperative paravertebral catheter at a rate of 0.1 ml/kg/h. Receives: Drug: Lidocaine |
| no lidocaine | Active comparator | Group 3: intravenous remifentanil and paravertebral SF. During the maintenance of anesthesia, a continuous intravenous infusion of remifentanil at a rate of 0.1 mg/kg/min until the end of surgery and an infusion of 0.9% SF through the intraoperative paravertebral catheter at a rate of 0.1 ml / kg / h. Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
to compare the proportion of patients included in the different scales of the Clavien-Dindo classification of postoperative complications reviewed for thoracic surgery in the three groups of patients. Patients will be followed from the day of hospital admission until hospital discharge and up to 30 days after the surgery
Measured: up to 30 days after intervention
Secondary outcomes (10)
gas exchange
Compare the gas exchange (PaO2 / FiO2) at 24 hours after the intervention between the three groups of the study.
Measured: 24 hours
Differences between three groups in Inflammatory biomarkers (IL 1, IL 2, IL 6, IL 8, IL 10, TNF alpha, MCP-1) measure in serum and bronchoalveolar lavage during 24 hours after the surgery.
To evaluate the effect of intravenous lidocaine on the inflammatory response in lung resection surgery by measuring the inflammatory biomarkers (Interleukin(IL) 1, IL 2, IL 6, IL8, IL 10, tumor necrosis factor alfa and monocyte chemoattractant protein) in serum and in bronchoalveolar lavage, compared to the other two groups of patients. Blood samples are taken at the beginning of the surgery, at the end of the one lung ventilation, and at 24 hours postoperatively. Bronchoalveolar lavage is done just before the beginning of one lung ventilation and at the end of one lung ventilation
Measured: up to 24 hours of intervention
Analgesic requirements of opioids in the first 24 hours after the surgery
To compare the analgesic requirements of opioids in the immediate postoperative period (first 24 hours after the surgery) between the three groups of the study. When patients will be admitted in the postoperative care Unit a patient controlled analgesia pump of intravenous morphine 0,1% (bolus of 1mg) will be connected. The total dose of morphine self-administered by the patient in the first 24 hours after surgery will be recorded.
Measured: 24 hours
Special Care Units stay
To compare the average stay (measure in hours) in Special Care Units among the three groups of the study
Measured: up to 30 days after intervention
Hospital stay
To compare the average hospital stay (measure in days) among the three groups of the study
Measured: up to 30 days after intervention
Re-admissions in Special Care Units
To compare the number of re-admissions in Special Care Units among the three groups of the study in the 30 days after the intervention.
Measured: up to 30 days after intervention
Postoperative cognitive dysfunction measure by mini mental state examination
To analyze the incidence of postoperative cognitive dysfunction (POCD) in the three groups by comparing the mini mental state examination performed at admission and 3 days after the intervention.
Measured: up to 3 days after intervention
Neuro-inflammatory response measure by the synthesis of protein S-100 beta in serum
To evaluated the neuro-inflammatory response by the synthesis of protein S-100 beta measured in serum in the first 24 hours postoperatively in the three groups of patients. Blood samples are taken at the beginning of the surgery, at the end of the one lung ventilation, and at 24 hours postoperatively
Measured: up to 24 hours after intervention
Neuro-inflammatory response measure by the synthesis of neuronal specific enolase in serum
To evaluated the neuro-inflammatory response by the synthesis of neuronal specific enolase measured in serum in the first 24 hours postoperatively in the three groups of patients. Blood samples are taken at the beginning of the surgery, at the end of the one lung ventilation, and at 24 hours postoperatively
Measured: up to 24 hours after intervention
Neuro-inflammatory response measure by the synthesis of glial fibrillary acidic protein
To evaluated the neuro-inflammatory response by the synthesis of glial fibrillary acidic protein measured in serum in the first 24 hours postoperatively in the three groups of patients. Blood samples are taken at the beginning of the surgery, at the end of the one lung ventilation, and at 24 hours postoperatively
Measured: up to 24 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start28 Jan 2019
- Primary completion2 Jun 2021
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unicentric, randomized, blind and controlled phase IV Clinical trial of three parallel groups. Randomization: Patients will be randomized into three groups (ratio 1: 1: 1): intravenous lidocaine and paravertebral saline (group 1), intravenous and paravertebral saline solution with lidocaine (group 2) and intravenous remifentanil and paravertebral saline solution (group 3) ). The randomization will be carried out through the EPIDAT 3.1 program prior to the recruitment of the first patient and the randomization codes will be kept in a sealed envelope with the number on the outside of the envelope. Patients will be followed from the day of hospital admission until hospital discharge and after 30 days of surgery.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francisco Andres de la Gala
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor-investigator, Francisco Andres de la Gala, Hospital General Universitario Gregorio Marañon
- Investigators
- Francisco de la Gala, MD PhD, Principal investigator, Hospital Gregorio Maranon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905837
- Sponsor's protocol ID
- IGMFGG-2016
- Status last verified
- Aug 2021
- First submitted
- 26 Mar 2019
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de la Gala F, de la Fuente E, Pineiro P, Reyes A, Duque P, Sanchez-Pedrosa G, Martinez-Gascuena D, Vara E, Rancan L, Simon C, Hortal J, Garutti I. Effect of intraoperative paravertebral or intravenous lidocaine infusion on postoperative complications and inflammation after lung resection surgery: a randomised controlled trial. Br J Anaesth. 2025 Nov;135(5):1297-1306. doi: 10.1016/j.bja.2025.05.059. Epub 2025 Sep 1.
PubMed 40897588De la Gala F, Pineiro P, Reyes A, Simon C, Vara E, Rancan L, Huerta LJ, Gonzalez G, Benito C, Munoz M, Grande P, Paredes SD, Aznar PT, Perez A, Martinez D, Higuero F, Sanz D, De Miguel JP, Cruz P, Olmedilla L, Lopez Gil E, Duque P, Sanchez-Pedrosa G, Valle M, Garutti I. Effect of intraoperative paravertebral or intravenous lidocaine versus control during lung resection surgery on postoperative complications: A randomized controlled trial. Trials. 2019 Nov 6;20(1):622. doi: 10.1186/s13063-019-3677-9.
PubMed 31694684
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Administration of Intravenous or Paravertebral Lidocaine in Continuous Perfusion During the Intraoperative Period of Lung Resection Surgery on the Appearance of Postoperative Complications
- ClinicalTrials.gov ID
- NCT03905837
- Acronym / sponsor ID
- IGMFGG-2016
- Keywords
- lidocaine, postoperative complications, thoracic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Francisco Andres de la GalaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 5 Apr 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.
The purpose of this study is to analyze the impact of the intravenous (IV) or paravertebral (PV) lidocaine administration during the intraoperative period of lung resection surgery on the appearance of postoperative complications. We design a randomized, controlled and blinded study to be performed in 153 patients with 3 arms: 1) Lidocaine IV + PV saline 2) saline IV + PV lidocaine, 3) remifentanil IV + PV saline. Perioperative analysis of inflammatory biomarkers in bronchoalveolar lavage and serum. Follow-up of the postoperative course, especially the appearance of postoperative complications according to the revised Clavien-Dindo classification for thoracic surgery, as well as other relevant clinical results.
Detailed description
Postoperative pulmonary complications continue to be one of the main causes of morbidity, mortality and increase in hospital stay in patients undergoing surgical procedures requiring anesthesia. Its incidence in lung resection surgery is greater than in other non-cardiac major surgeries due to damage of structures related to respiratory function.
Furthermore, during lung resection surgery there is an exaggerated pulmonary inflammatory response related to the use of one-lung ventilation and / or the lung damage produced by the collapse of the operated lung as well as the surgical manipulation itself.
Recently, in a clinical trial on 180 patients (NCT 02168751), our researcher group observed that the attenuation of the pulmonary inflammatory response through the use of halogenated anesthetic agents, was related to a decrease in the appearance of postoperative pulmonary complications after lung resection surgery. In addition, the presence, in bronchoalveolar lavages, of elevated levels of tumor necrosis factor-alpha, interleukine(IL)-6 and the IL-6 / IL10 ratio were independent predictors of the risk of developing postoperative pulmonary complications.
Lidocaine is a local anesthetic that blocks nerve conduction by blocking sodium channels. In addition it has been known for experimental and clinical studies of its immunomodulatory properties.
Clinical studies performed in different surgeries show that a continuous intravenous infusion of lidocaine during surgery is associated with a lower inflammatory response assessed by monitoring plasma cytokines, as well as less postoperative pain, a shorter duration of postoperative paralytic ileus and a early hospital discharge.
Currently, there is no clinical study that has evaluated the role of intravenous lidocaine on the pulmonary inflammatory response and the subsequent lung damage that inevitably occurs during lung resection surgery with periods of one lung ventilation.
Currently, some experts are proposing the replacement of thoracic epidural and paravertebral analgesia by the intravenous infusion of lidocaine and minor analgesics, for fast-track programs, based on their analgesic and anti-inflammatory capacity and on avoiding the risks inherent in the insertion of an epidural or paravertebral catheter.
Hypothesis: The administration of intravenous or paravertebral lidocaine during lung resection surgery attenuates the exaggerated inflammatory response that inevitably occurs in this surgical intervention. The lower expression of pro-inflammatory mediators will be associated with a lower rate of postoperative complications that are related to the perioperative inflammatory process.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Unicentric, randomized, blind and controlled phase IV Clinical trial of three parallel groups. Randomization: Patients will be randomized into three groups (ratio 1: 1: 1): intravenous lidocaine and paravertebral saline (group 1), intravenous and paravertebral saline solution with lidocaine (group 2) and intravenous remifentanil and paravertebral saline solution (group 3) ). The randomization will be carried out through the EPIDAT 3.1 program prior to the recruitment of the first patient and the randomization codes will be kept in a sealed envelope with the number on the outside of the envelope. Patients will be followed from the day of hospital admission until hospital discharge and after 30 days of surgery.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine IV | Experimental | Drug: LidocaineGroup 1: intravenous lidocaine and paravertebral saline (SF). In this group during intraoperative anesthetic maintenance, a continuous intravenous infusion of lidocaine at 1.5mg/kg/h until the end of surgery and perfusion of 0.9% SF through the intraoperative paravertebral catheter at a rate of 0.1ml/kg/h will be administered. |
| Lidocaine PV | Experimental | Drug: LidocaineGroup 2: intravenous SF and paravertebral lidocaine. During anesthesia maintenance, a continuous intravenous infusion of 0.9% SF and an infusion of 2% lidocaine will be administered through the intraoperative paravertebral catheter at a rate of 0.1 ml/kg/h. |
| no lidocaine | Active comparator | Drug: RemifentanilGroup 3: intravenous remifentanil and paravertebral SF. During the maintenance of anesthesia, a continuous intravenous infusion of remifentanil at a rate of 0.1 mg/kg/min until the end of surgery and an infusion of 0.9% SF through the intraoperative paravertebral catheter at a rate of 0.1 ml / kg / h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of both sexes undergoing lung resection surgery at the Thoracic Surgery Service at the Gregorio Maranón hospital.
- Patients who voluntarily accept to participate in the study and sign the informed consent
- Age> 18 years and legally capable
- Scheduled surgery.
- Functional respiratory tests with forced expiratory volume at one second > 50% or forced vital capacity > 50% preoperatively performed on these patients routinely.
Key exclusion criteria (4 listed)
- Pregnancy and lactation
- Known hypersensitivity to amide-type local anesthetics.
- Transfusion of blood products in the previous 10 days.
- Impossibility of performing mechanical ventilation for pulmonary protection.
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 |
|---|---|---|
| LidocaineAlso: Lignocaine, N-(2,6-dimethylphenyl)-N2,N2-diethylglycinamideIntravenous or paravertebral lidocaine | Drug | Lidocaine IV, Lidocaine PV |
| RemifentanilAlso: methyl 1-(2-methoxycarbonylethyl)-4-(phenyl-propanoyl-amino)-piperidine-4-carboxylateintravenous remifentanil | Drug | no lidocaine |
Primary outcome
Postoperative complications
Time frame: up to 30 days after intervention
to compare the proportion of patients included in the different scales of the Clavien-Dindo classification of postoperative complications reviewed for thoracic surgery in the three groups of patients. Patients will be followed from the day of hospital admission until hospital discharge and up to 30 days after the surgery
10 secondary outcomes
gas exchange
Time frame: 24 hours
Differences between three groups in Inflammatory biomarkers (IL 1, IL 2, IL 6, IL 8, IL 10, TNF alpha, MCP-1) measure in serum and bronchoalveolar lavage during 24 hours after the surgery.
Time frame: up to 24 hours of intervention
Analgesic requirements of opioids in the first 24 hours after the surgery
Time frame: 24 hours
Special Care Units stay
Time frame: up to 30 days after intervention
Hospital stay
Time frame: up to 30 days after intervention
Re-admissions in Special Care Units
Time frame: up to 30 days after intervention
Postoperative cognitive dysfunction measure by mini mental state examination
Time frame: up to 3 days after intervention
Neuro-inflammatory response measure by the synthesis of protein S-100 beta in serum
Time frame: up to 24 hours after intervention
Neuro-inflammatory response measure by the synthesis of neuronal specific enolase in serum
Time frame: up to 24 hours after intervention
Neuro-inflammatory response measure by the synthesis of glial fibrillary acidic protein
Time frame: up to 24 hours after intervention
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 25 Aug 2021.
- Derived from this study: PubMed 40897588de la Gala F, de la Fuente E, Pineiro P, Reyes A, Duque P, Sanchez-Pedrosa G, Martinez-Gascuena D, Vara E, Rancan L, Simon C, Hortal J, Garutti I. Effect of intraoperative paravertebral or intravenous lidocaine infusion on postoperative complications and inflammation after lung resection surgery: a randomised controlled trial. Br J Anaesth. 2025 Nov;135(5):1297-1306. doi: 10.1016/j.bja.2025.05.059. Epub 2025 Sep 1.
- Derived from this study: PubMed 31694684De la Gala F, Pineiro P, Reyes A, Simon C, Vara E, Rancan L, Huerta LJ, Gonzalez G, Benito C, Munoz M, Grande P, Paredes SD, Aznar PT, Perez A, Martinez D, Higuero F, Sanz D, De Miguel JP, Cruz P, Olmedilla L, Lopez Gil E, Duque P, Sanchez-Pedrosa G, Valle M, Garutti I. Effect of intraoperative paravertebral or intravenous lidocaine versus control during lung resection surgery on postoperative complications: A randomized controlled trial. Trials. 2019 Nov 6;20(1):622. doi: 10.1186/s13063-019-3677-9.
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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.
Francisco de la Gala, MD PhD principal investigator
Hospital Gregorio Maranon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine and Remifentanil in people with Lung Diseases and Lung Inflammation, run by Francisco Andres de la Gala at 1 site in Spain.
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 4 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 25 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Postoperative complications (time frame: up to 30 days after intervention). 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 NCT03905837, which also lists 2 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 25 Aug 2021.