Renal Transplant Donor of Left KidneyNCT03520205
Quadratus Lumborum Block Versus Epidural for Laparoscopic Nephrectomy Kidney Donor
A study testing Quadratus Lumborum Block and Continuous Epidural in people with Renal Transplant Donor of Left Kidney, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aimed to compare Quadratus Lumborum Block to Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Transplant Donor of Left Kidney
- What is being tested?
- Quadratus Lumborum Block and Continuous Epidural
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2018to 31 Dec 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Kidney donor patients undergoing laparoscopic nephrectomy
- Body mass index below 30
- Duration of surgery 4 to 6 hours
- Patients who agreed to participate in this study and sign informed consent.
Who cannot join
- Have contraindication for quadratus lumborum block
- Have contraindication for epidural
- Previous history of local anesthetic drug allergy
- inability to communicate
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Central National Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: Comparison Between Quadratus Lumborum Block and Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor
This study aimed to compare Quadratus Lumborum Block to Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor
Read the detailed description
Sixty-two subjects were given informed consent before enrolling the study and randomized into two groups; quadratus lumborum block and epidural. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse-oxymetry were set on the subjects in the operation room. General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 1-2 mg/kg. Endotracheal tube (ETT) intubation was facilitated with Atracurium 0.5mg/kg as muscle relaxant. Maintenance was done by sevoflurane, oxygen, and compressed air. On quadratus lumborum block group, bilateral block using ultrasound will be performed with stimuplex 100mm needle with 20 cc of bupivacaine 0.25% as regimen. On epidural group, epidural catheter was inserted under general anaesthesia on left lateral decubitus position (5 cm depth inside the epidural space) at level Th10-Th11. The catheter insertion was confirmed with vacuum aspiration and negative test-dose. Before first incision, patient will be given continuous epidural Bupivacaine 0.25% 6 mL/hour. Blood sample was drawn for interleukin-6, blood glucose, and c-reactive protein as baseline data. After surgery, patient were extubated until fully conscious and can follow command verbally. Patient will be transported in recovery room post operation.
- Conditions
- Renal Transplant Donor of Left Kidney
- Being tested
- Quadratus Lumborum Block, Continuous Epidural
- Keywords
- stress response, kidney donor, Cellular Imunological Function, quadratus lumborum block, numerical rating scale, morphine patient controlled analgesia
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus Lumborum BlockProcedure or surgery
Bilateral block using ultrasound will be performed before surgery and after surgery on patient using Stimuplex 100mm needle with Bupivacaine 0.25% 0.4 mL/kg, maximum dose 25 mL each side under general anaesthesia
Continuous EpiduralProcedure or surgery
Patient will be given 6 mL/hour of Bupivacaine 0.25% for intraoperative analgesia and continued epidural 6 mL/hour Bupivacaine 0,125% as postoperative analgesia in 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Quadratus Lumborum Block | Active comparator | Patient will receive quadratus lumborum block Receives: Procedure: Quadratus Lumborum Block |
| Continuous Epidural | Active comparator | Patient will receive epidural anesthesia Receives: Procedure: Continuous Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Interleukin-6 at 24 hours after abdominal insufflation
Measure by ELISA
Measured: Before procedure, at the end of surgery, and 24 hours after abdominal insufflation
Cumulative morphine requirement at 2 hours, 6 hours, 12 hours, 24 hours postoperative
Cumulative morphine consumption at each time point in 24 hours after surgery
Measured: 2 hours, 6 hours, 12 hours, 24 hours.
Secondary outcomes (14)
Change from Baseline Patient Controlled Analgesia at 2, 6, 12 and 24 hours after procedure
Measure by how many times patient use morphine PCA analgesia
Measured: 2, 6, 12, and 24 hours after procedure
Change from Baseline Pain Intensity at 2, 6, 12, and 24 hours after procedure
Measured by Numerical Rating Scale
Measured: 2, 6, 12, and 24 hours after procedure
Change from Baseline Blood Glucose at 2 hours after abdominal insufflation
Measured by finger-stick blood sample
Measured: Before procedure and 2 hours after abdominal insufflation
Change from Baseline Blood pressure
Measured by non-invasive blood pressure monitoring at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery
Measured: Intraoperative and 24 hours
Change from Baseline Mean Arterial Pressure
Measured by non-invasive blood pressure monitoring at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery
Measured: Intraoperative and 24 hours
Change from Baseline Cardiac Index
Measured by cardiometry ICON® at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery
Measured: Intraoperative and 24 hours
Change from Baseline Heart Rate
Measured by pulse oximetry at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery
Measured: Intraoperative and 24 hours
Change from Baseline hs-CRP at 48 hours after abdominal insufflation
Measured with ELISA
Measured: Before procedure, at the end of surgery, and 48 hours after abdominal insufflation
Time to first morphine requirement
Duration from end of anesthesia until first attempt of morphine requirement in minutes
Measured: 24 hours
Total bupivacaine used in 24 hours
Total bupivacaine used until 24 hours postoperatively
Measured: 24 hours
Change from baseline motor block at 2, 6, 12, and 24 hours after anesthesia recovery
Measured by Bromage score
Measured: 2, 6, 12, and 24 hours after procedure
Number of participants with paresthesia after procedure
in percentage
Measured: 24 hours
Duration of urinary catheter
in hours
Measured: 24 hours
Level of sensory block after procedure
Measured by cold and pin prick sensation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start1 May 2018
- Primary completion30 Oct 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Renal Transplant Donor of Left KidneyStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Rosita Tantri, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520205
- Sponsor's protocol ID
- IndonesiaUAnes021
- Status last verified
- Oct 2019
- First submitted
- 15 Apr 2018
- Last updated
- 22 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mathuram Thiyagarajan U, Bagul A, Nicholson ML. Pain management in laparoscopic donor nephrectomy: a review. Pain Res Treat. 2012;2012:201852. doi: 10.1155/2012/201852. Epub 2012 Oct 23.
PubMed 23150820SarinKapoor H, Kaur R, Kaur H. Anaesthesia for renal transplant surgery. Acta Anaesthesiol Scand. 2007 Nov;51(10):1354-67. doi: 10.1111/j.1399-6576.2007.01447.x.
PubMed 17944639Minnee RC, Idu MM. Laparoscopic donor nephrectomy. Neth J Med. 2010 May;68(5):199-206.
PubMed 20508268Buunen M, Gholghesaei M, Veldkamp R, Meijer DW, Bonjer HJ, Bouvy ND. Stress response to laparoscopic surgery: a review. Surg Endosc. 2004 Jul;18(7):1022-8. doi: 10.1007/s00464-003-9169-7. Epub 2004 May 12.
PubMed 15136930Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.
PubMed 10927999Das W, Bhattacharya S, Ghosh S, Saha S, Mallik S, Pal S. Comparison between general anesthesia and spinal anesthesia in attenuation of stress response in laparoscopic cholecystectomy: A randomized prospective trial. Saudi J Anaesth. 2015 Apr-Jun;9(2):184-8. doi: 10.4103/1658-354X.152881.
PubMed 25829908Gulyam Kuruba SM, Mukhtar K, Singh SK. A randomised controlled trial of ultrasound-guided transversus abdominis plane block for renal transplantation. Anaesthesia. 2014 Nov;69(11):1222-6. doi: 10.1111/anae.12704. Epub 2014 Jun 28.
PubMed 24974901Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
PubMed 28154824Skrekas G, Papalois VE, Mitsis M, Hakim NS. Laparoscopic live donor nephrectomy: a step forward in kidney transplantation? JSLS. 2003 Jul-Sep;7(3):197-206.
PubMed 14558706Oyen O, Scholz T, Hartmann A, Pfeffer P. Minimally invasive kidney transplantation: the first experience. Transplant Proc. 2006 Nov;38(9):2798-802. doi: 10.1016/j.transproceed.2006.08.102.
PubMed 17112833Jianda X, Yuxing Q, Yi G, Hong Z, Libo P, Jianning Z. Impact of Preemptive Analgesia on inflammatory responses and Rehabilitation after Primary Total Knee Arthroplasty: A Controlled Clinical Study. Sci Rep. 2016 Aug 31;6:30354. doi: 10.1038/srep30354.
PubMed 27578313Southworth SR, Woodward EJ, Peng A, Rock AD. An integrated safety analysis of intravenous ibuprofen (Caldolor((R))) in adults. J Pain Res. 2015 Oct 23;8:753-65. doi: 10.2147/JPR.S93547. eCollection 2015.
PubMed 26604816Spiro MD, Eilers H. Intraoperative care of the transplant patient. Anesthesiol Clin. 2013 Dec;31(4):705-21. doi: 10.1016/j.anclin.2013.09.005. Epub 2013 Nov 6.
PubMed 24287348Bhosale G, Shah V. Combined spinal-epidural anesthesia for renal transplantation. Transplant Proc. 2008 May;40(4):1122-4. doi: 10.1016/j.transproceed.2008.03.027.
PubMed 18555130Aditianingsih D, Pryambodho, Anasy N, Tantri AR, Mochtar CA. A randomized controlled trial on analgesic effect of repeated Quadratus Lumborum block versus continuous epidural analgesia following laparoscopic nephrectomy. BMC Anesthesiol. 2019 Dec 5;19(1):221. doi: 10.1186/s12871-019-0891-7.
PubMed 31805855
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Quadratus Lumborum Block and Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor
- ClinicalTrials.gov ID
- NCT03520205
- Acronym / sponsor ID
- IndonesiaUAnes021
- Conditions
- Renal Transplant Donor of Left Kidney
- Keywords
- stress response, kidney donor, Cellular Imunological Function, quadratus lumborum block, numerical rating scale, morphine patient controlled analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 9 May 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.
This study aimed to compare Quadratus Lumborum Block to Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor
Detailed description
Sixty-two subjects were given informed consent before enrolling the study and randomized into two groups; quadratus lumborum block and epidural. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse-oxymetry were set on the subjects in the operation room. General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 1-2 mg/kg. Endotracheal tube (ETT) intubation was facilitated with Atracurium 0.5mg/kg as muscle relaxant. Maintenance was done by sevoflurane, oxygen, and compressed air. On quadratus lumborum block group, bilateral block using ultrasound will be performed with stimuplex 100mm needle with 20 cc of bupivacaine 0.25% as regimen. On epidural group, epidural catheter was inserted under general anaesthesia on left lateral decubitus position (5 cm depth inside the epidural space) at level Th10-Th11. The catheter insertion was confirmed with vacuum aspiration and negative test-dose. Before first incision, patient will be given continuous epidural Bupivacaine 0.25% 6 mL/hour. Blood sample was drawn for interleukin-6, blood glucose, and c-reactive protein as baseline data. After surgery, patient were extubated until fully conscious and can follow command verbally. Patient will be transported in recovery room post operation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus Lumborum Block | Active comparator | Procedure: Quadratus Lumborum BlockPatient will receive quadratus lumborum block |
| Continuous Epidural | Active comparator | Procedure: Continuous EpiduralPatient will receive epidural anesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Kidney donor patients undergoing laparoscopic nephrectomy
- Body mass index below 30
- Duration of surgery 4 to 6 hours
- Patients who agreed to participate in this study and sign informed consent.
Key exclusion criteria (4 listed)
- Have contraindication for quadratus lumborum block
- Have contraindication for epidural
- Previous history of local anesthetic drug allergy
- inability to communicate
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 |
|---|---|---|
| Quadratus Lumborum BlockBilateral block using ultrasound will be performed before surgery and after surgery on patient using Stimuplex 100mm needle with Bupivacaine 0.25% 0.4 mL/kg, maximum dose 25 mL each side under general anaesthesia | Procedure or surgery | Quadratus Lumborum Block |
| Continuous EpiduralPatient will be given 6 mL/hour of Bupivacaine 0.25% for intraoperative analgesia and continued epidural 6 mL/hour Bupivacaine 0,125% as postoperative analgesia in 24 hours. | Procedure or surgery | Continuous Epidural |
Primary outcome
Change from Baseline Interleukin-6 at 24 hours after abdominal insufflation
Time frame: Before procedure, at the end of surgery, and 24 hours after abdominal insufflation
Measure by ELISA
Cumulative morphine requirement at 2 hours, 6 hours, 12 hours, 24 hours postoperative
Time frame: 2 hours, 6 hours, 12 hours, 24 hours.
Cumulative morphine consumption at each time point in 24 hours after surgery
14 secondary outcomes
Change from Baseline Patient Controlled Analgesia at 2, 6, 12 and 24 hours after procedure
Time frame: 2, 6, 12, and 24 hours after procedure
Change from Baseline Pain Intensity at 2, 6, 12, and 24 hours after procedure
Time frame: 2, 6, 12, and 24 hours after procedure
Change from Baseline Blood Glucose at 2 hours after abdominal insufflation
Time frame: Before procedure and 2 hours after abdominal insufflation
Change from Baseline Blood pressure
Time frame: Intraoperative and 24 hours
Change from Baseline Mean Arterial Pressure
Time frame: Intraoperative and 24 hours
Change from Baseline Cardiac Index
Time frame: Intraoperative and 24 hours
Change from Baseline Heart Rate
Time frame: Intraoperative and 24 hours
Change from Baseline hs-CRP at 48 hours after abdominal insufflation
Time frame: Before procedure, at the end of surgery, and 48 hours after abdominal insufflation
Time to first morphine requirement
Time frame: 24 hours
Total bupivacaine used in 24 hours
Time frame: 24 hours
Change from baseline motor block at 2, 6, 12, and 24 hours after anesthesia recovery
Time frame: 2, 6, 12, and 24 hours after procedure
Number of participants with paresthesia after procedure
Time frame: 24 hours
Duration of urinary catheter
Time frame: 24 hours
Level of sensory block after procedure
Time frame: 24 hours
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 22 Oct 2019.
- Background: PubMed 23150820Mathuram Thiyagarajan U, Bagul A, Nicholson ML. Pain management in laparoscopic donor nephrectomy: a review. Pain Res Treat. 2012;2012:201852. doi: 10.1155/2012/201852. Epub 2012 Oct 23.
- Background: PubMed 17944639SarinKapoor H, Kaur R, Kaur H. Anaesthesia for renal transplant surgery. Acta Anaesthesiol Scand. 2007 Nov;51(10):1354-67. doi: 10.1111/j.1399-6576.2007.01447.x.
- Background: PubMed 20508268Minnee RC, Idu MM. Laparoscopic donor nephrectomy. Neth J Med. 2010 May;68(5):199-206.
- Background: PubMed 15136930Buunen M, Gholghesaei M, Veldkamp R, Meijer DW, Bonjer HJ, Bouvy ND. Stress response to laparoscopic surgery: a review. Surg Endosc. 2004 Jul;18(7):1022-8. doi: 10.1007/s00464-003-9169-7. Epub 2004 May 12.
- Background: PubMed 10927999Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.
- Background: PubMed 25829908Das W, Bhattacharya S, Ghosh S, Saha S, Mallik S, Pal S. Comparison between general anesthesia and spinal anesthesia in attenuation of stress response in laparoscopic cholecystectomy: A randomized prospective trial. Saudi J Anaesth. 2015 Apr-Jun;9(2):184-8. doi: 10.4103/1658-354X.152881.
- Background: PubMed 24974901Gulyam Kuruba SM, Mukhtar K, Singh SK. A randomised controlled trial of ultrasound-guided transversus abdominis plane block for renal transplantation. Anaesthesia. 2014 Nov;69(11):1222-6. doi: 10.1111/anae.12704. Epub 2014 Jun 28.
- Background: PubMed 28154824Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
- Background: PubMed 14558706Skrekas G, Papalois VE, Mitsis M, Hakim NS. Laparoscopic live donor nephrectomy: a step forward in kidney transplantation? JSLS. 2003 Jul-Sep;7(3):197-206.
- Background: PubMed 17112833Oyen O, Scholz T, Hartmann A, Pfeffer P. Minimally invasive kidney transplantation: the first experience. Transplant Proc. 2006 Nov;38(9):2798-802. doi: 10.1016/j.transproceed.2006.08.102.
- Background: PubMed 27578313Jianda X, Yuxing Q, Yi G, Hong Z, Libo P, Jianning Z. Impact of Preemptive Analgesia on inflammatory responses and Rehabilitation after Primary Total Knee Arthroplasty: A Controlled Clinical Study. Sci Rep. 2016 Aug 31;6:30354. doi: 10.1038/srep30354.
- Background: PubMed 26604816Southworth SR, Woodward EJ, Peng A, Rock AD. An integrated safety analysis of intravenous ibuprofen (Caldolor((R))) in adults. J Pain Res. 2015 Oct 23;8:753-65. doi: 10.2147/JPR.S93547. eCollection 2015.
- STRESS RESPONSE AND ANAESTHESIA ALTERING THE PERI AND POST-OPERATIVE MANAGEMENTLink provided by the sponsor.
- Efficacy of parecoxib on the level of IL-6, CRP, and postoperative pain relief after percutaneous nephrolithotomyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Renal Transplant Donor of Left Kidney
Active, not recruitingObservational study
Evaluation of Regret in Kidney Transplantation
Renal Transplant Candidate for Right Kidney, Renal Transplant Candidate for Left Kidney
Active, not recruitingObservational study
TransplantLines Food and Nutrition Biobank and Cohort Study (TxL-FN)
Transplantation Infection, Renal Transplant Donor of Left Kidney
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadratus Lumborum Block and Continuous Epidural in people with Renal Transplant Donor of Left Kidney, run by Universitas Indonesia at 1 site in Indonesia.
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 4 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 22 Oct 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 Indonesia. 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?
Change from Baseline Interleukin-6 at 24 hours after abdominal insufflation (time frame: Before procedure, at the end of surgery, and 24 hours after abdominal insufflation). The study lists 2 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 NCT03520205, which also lists 15 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 22 Oct 2019.