Surgical ViewNCT03179111
Evaluation of Low Pressure Pneumoperitoneum in Bariatric Surgery (ELOPES Study)
A study testing Pneumoperitoneum Pressure in people with Surgical View and Shoulder Tip Pain, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
This is a prospective study whereby it involves patients who are planned for bariatric surgery. In the bariatric surgery procedure, pneumoperitoneum pressure will be the experimental aspect in this study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Surgical View, Shoulder Tip Pain, Abdominal Pain
- What is being tested?
- Pneumoperitoneum Pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 Aug 2017to 4 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- Ability to give informed consent
- Patients who are approved by the anaesthetics to undergo bariatric surgery.
Who cannot join
- Age below 18 and above 70
- Inability to give informed consent
- Patient unfit for bariatric surgery including who has poor respiratory, cardiac, renal and liver function.
- Patient with Body Mass Index (BMI) >50
- Patient with American Society of Anesthesiologists (ASA) >3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Low Pressure Pneumoperitoneum in Bariatric Surgery: A Prospective Randomized Study
This is a prospective study whereby it involves patients who are planned for bariatric surgery. In the bariatric surgery procedure, pneumoperitoneum pressure will be the experimental aspect in this study. The pneumoperitoneum pressure will be adjusted to either 8-10 mmHg of low pressure or to 12-15mmHg of standard pressure.
Read the detailed description
This will be a prospective study in patients aged between 18 and 70 years old who have already been screened and planned for elective bariatric surgery. In bariatric surgery, a large portion of the stomach will be removed. Pneumoperitoneum is also known as the abdominal pressure which will be the experimental aspect in this study. Laparoscopy surgery will be performed by introducing the camera (optical trocar) after making an incision at the belly button (umbilicus), and carbon dioxide which will be given at a rate of 5 L/min until the intra-abdominal pressure of either 8-10 mmHg (low-pressure group) or 12-15 mmHg (standard pressure group) is achieved. The remaining three standard ports will be placed and the laparoscopic sleeve gastrectomy will be performed at an insufflation rate of 15 L/min. The greater omentum will be divided at the greater curvature of the stomach using an ultrasonic dissector, beginning from the proximal antrum until the fundus. The omentum will be divided close to the stomach wall hence preserving the gastro-epiploic vessels. Short gastric vessels will be divided entirely from the stomach and this dissection will continue until the left crus of the diaphragm are exposed. Endoscopic staplers will then be used to staple and divide the stomach until the angle of His. A 39Fr gastric calibration tube will be placed along the lesser curvature of the stomach, acts as a guide during the division of the stomach. Finally, the divided stomach will be removed through a 12mm port site and the incision will be closed with sutures.
Towards the end of the surgery, all residual pneumoperitoneum will be evacuated by keeping the trocar valves open under direct telescopic vision. The duration of surgery or any intraoperative complications will be recorded. The starting of surgery will be regarded after the induction of anaesthesia and the end of surgery is regarded when the end of skin closure. Operating field or also known as surgical view is defined as the view of the intra-abdomen. A clear operating field allows a good working space for the surgeon. Numeric rating score will be used to access the operating field during the surgery. Post-operative pain will be rated on a Visual Analog Scale at rest and with movement.
- Conditions
- Surgical View, Shoulder Tip Pain, Abdominal Pain
- Being tested
- Pneumoperitoneum Pressure
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumoperitoneum PressureProcedure or surgery
There will be two arms in this study. The participants recruited for this study are those who have been screened and planned for elective bariatric surgery.The pneumoperitoneum pressure will be adjusted to either 8-10mmHg or 12-15mmHg until a clear operating field is obtained by the surgeon. Low pneumoperitoneum pressure has been expected to give a clearer and better surgical view than standard pneumoperitoneum pressure. Participants under the low pressure group are expected to have lesser pain score on abdominal pain and shoulder tip pain as compared to participants in the standard pressure group.
| Study group | Role | What they receive |
|---|---|---|
| Low Pressure Group | Experimental | Participants will undergo elective bariatric surgery. Participants under this group will be given intra-abdominal pressure of 8-10mmHg. The number of subjects anticipated for this arm will be 47. Participants in this low pressure group are expected to encounter lesser shoulder tip pain and abdominal pain. Operating field for surgeons also expected to be better. Receives: Procedure: Pneumoperitoneum Pressure |
| Standard Pressure Group | Experimental | Participants will undergo elective bariatric surgery. Participants under this group will be given intra-abdominal pressure of 12-15mmHg. The number of subjects anticipated for this arm will be 47. Participants in this group are expected to have an increased amount of shoulder tip pain and higher pain score postoperatively compared to low pressure group. Operating fields for surgeons are expected to be less clear. Receives: Procedure: Pneumoperitoneum Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operating Field
Numeric rating score will be used to access the operating field during the surgery. The numeric rating score will be recorded after the surgery by the surgeon. The score ranges from 1 to 4 whereby 1 means poor space with excessive muscular contractions and unable to proceed with surgery safely. Numeric rating scale of 4 indicates good surgical space. If there was any compromise of the operating field (NOS score ≥ 3), the pneumoperitoneum pressure will be increased accordingly.
Measured: It will be assessed intraoperatively (during the surgery).
Secondary outcomes (2)
Pain Score
The pain score will be assessed using visual analog scale (VAS) (0-10). A score of 0 means no pain, whereas a score of 10 equals the worst pain ever experienced. Post-operative pain will be rated on a visual analog score at rest. The time of arrival in the postoperative recovery room will be defined as zero hours postoperatively. The patients will be asked about the location of pain, whether at the shoulder, incision sites, and/or inside the abdomen by the medical doctors or nurses.
Measured: The abdomen and shoulder tip pain intensity will be rated up to 48 hours postoperatively.
Duration of Surgery
The duration of surgery or any intraoperative complications will be recorded.
Measured: The starting of surgery will be regarded after the induction of anaesthesia and the end of surgery is regarded when the end of skin closure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start30 Aug 2017
- Primary completion4 May 2018
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Surgical ViewStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two arms in this study. One arm will be the low pressure pneumoperitoneum group (8-10mmHg) where else the other arm will be the standard pressure pneumoperitoneum group (12-15mmHg).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tikfu Gee, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179111
- Sponsor's protocol ID
- NMRR-16-1488-32135 (IIR)
- Status last verified
- May 2018
- First submitted
- 24 May 2017
- Last updated
- 7 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Lindekaer AL, Riber C, Gatke MR. Surgical space conditions during low-pressure laparoscopic cholecystectomy with deep versus moderate neuromuscular blockade: a randomized clinical study. Anesth Analg. 2014 Nov;119(5):1084-92. doi: 10.1213/ANE.0000000000000316.
PubMed 24977638Neudecker J, Sauerland S, Neugebauer E, Bergamaschi R, Bonjer HJ, Cuschieri A, Fuchs KH, Jacobi Ch, Jansen FW, Koivusalo AM, Lacy A, McMahon MJ, Millat B, Schwenk W. The European Association for Endoscopic Surgery clinical practice guideline on the pneumoperitoneum for laparoscopic surgery. Surg Endosc. 2002 Jul;16(7):1121-43. doi: 10.1007/s00464-001-9166-7. Epub 2001 May 20.
PubMed 12015619Litynski GS. Kurt Semm and an automatic insufflator. JSLS. 1998 Apr-Jun;2(2):197-200.
PubMed 9876740Ibraheim OA, Samarkandi AH, Alshehry H, Faden A, Farouk EO. Lactate and acid base changes during laparoscopic cholecystectomy. Middle East J Anaesthesiol. 2006 Feb;18(4):757-68.
PubMed 16749570Schietroma M, Carlei F, Mownah A, Franchi L, Mazzotta C, Sozio A, Amicucci G. Changes in the blood coagulation, fibrinolysis, and cytokine profile during laparoscopic and open cholecystectomy. Surg Endosc. 2004 Jul;18(7):1090-6. doi: 10.1007/s00464-003-8819-0. Epub 2004 May 12.
PubMed 15136925Esmat ME, Elsebae MM, Nasr MM, Elsebaie SB. Combined low pressure pneumoperitoneum and intraperitoneal infusion of normal saline for reducing shoulder tip pain following laparoscopic cholecystectomy. World J Surg. 2006 Nov;30(11):1969-73. doi: 10.1007/s00268-005-0752-z.
PubMed 17043939Schietroma M, Pessia B, Stifini D, Lancione L, Carlei F, Cecilia EM, Amicucci G. Effects of low and standard intra-abdominal pressure on systemic inflammation and immune response in laparoscopic adrenalectomy: A prospective randomised study. J Minim Access Surg. 2016 Apr-Jun;12(2):109-17. doi: 10.4103/0972-9941.178513.
PubMed 27073301Gurusamy KS, Vaughan J, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 18;2014(3):CD006930. doi: 10.1002/14651858.CD006930.pub3.
PubMed 24639018Nguyen NT, Wolfe BM. The physiologic effects of pneumoperitoneum in the morbidly obese. Ann Surg. 2005 Feb;241(2):219-26. doi: 10.1097/01.sla.0000151791.93571.70.
PubMed 15650630Buunen 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 15136930Gupta A, Watson DI. Effect of laparoscopy on immune function. Br J Surg. 2001 Oct;88(10):1296-306. doi: 10.1046/j.0007-1323.2001.01860.x.
PubMed 11578282Sylla P, Kirman I, Whelan RL. Immunological advantages of advanced laparoscopy. Surg Clin North Am. 2005 Feb;85(1):1-18, vii. doi: 10.1016/j.suc.2004.09.005.
PubMed 15619524Hajri A, Mutter D, Wack S, Bastien C, Gury JF, Marescaux J, Aprahamian M. Dual effect of laparoscopy on cell-mediated immunity. Eur Surg Res. 2000;32(5):261-6. doi: 10.1159/000008773.
PubMed 11111169West MA, Baker J, Bellingham J. Kinetics of decreased LPS-stimulated cytokine release by macrophages exposed to CO2. J Surg Res. 1996 Jun;63(1):269-74. doi: 10.1006/jsre.1996.0259.
PubMed 8661209Umar A, Mehta KS, Mehta N. Evaluation of hemodynamic changes using different intra-abdominal pressures for laparoscopic cholecystectomy. Indian J Surg. 2013 Aug;75(4):284-9. doi: 10.1007/s12262-012-0484-x. Epub 2012 May 1.
PubMed 24426454
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Low Pressure Pneumoperitoneum in Bariatric Surgery: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03179111
- Acronym / sponsor ID
- NMRR-16-1488-32135 (IIR)
- Conditions
- Surgical View, Shoulder Tip Pain, Abdominal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 7 Jun 2017 (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 is a prospective study whereby it involves patients who are planned for bariatric surgery. In the bariatric surgery procedure, pneumoperitoneum pressure will be the experimental aspect in this study. The pneumoperitoneum pressure will be adjusted to either 8-10 mmHg of low pressure or to 12-15mmHg of standard pressure.
Detailed description
This will be a prospective study in patients aged between 18 and 70 years old who have already been screened and planned for elective bariatric surgery. In bariatric surgery, a large portion of the stomach will be removed. Pneumoperitoneum is also known as the abdominal pressure which will be the experimental aspect in this study. Laparoscopy surgery will be performed by introducing the camera (optical trocar) after making an incision at the belly button (umbilicus), and carbon dioxide which will be given at a rate of 5 L/min until the intra-abdominal pressure of either 8-10 mmHg (low-pressure group) or 12-15 mmHg (standard pressure group) is achieved. The remaining three standard ports will be placed and the laparoscopic sleeve gastrectomy will be performed at an insufflation rate of 15 L/min. The greater omentum will be divided at the greater curvature of the stomach using an ultrasonic dissector, beginning from the proximal antrum until the fundus. The omentum will be divided close to the stomach wall hence preserving the gastro-epiploic vessels. Short gastric vessels will be divided entirely from the stomach and this dissection will continue until the left crus of the diaphragm are exposed. Endoscopic staplers will then be used to staple and divide the stomach until the angle of His. A 39Fr gastric calibration tube will be placed along the lesser curvature of the stomach, acts as a guide during the division of the stomach. Finally, the divided stomach will be removed through a 12mm port site and the incision will be closed with sutures.
Towards the end of the surgery, all residual pneumoperitoneum will be evacuated by keeping the trocar valves open under direct telescopic vision. The duration of surgery or any intraoperative complications will be recorded. The starting of surgery will be regarded after the induction of anaesthesia and the end of surgery is regarded when the end of skin closure. Operating field or also known as surgical view is defined as the view of the intra-abdomen. A clear operating field allows a good working space for the surgeon. Numeric rating score will be used to access the operating field during the surgery. Post-operative pain will be rated on a Visual Analog Scale at rest and with movement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- There will be two arms in this study. One arm will be the low pressure pneumoperitoneum group (8-10mmHg) where else the other arm will be the standard pressure pneumoperitoneum group (12-15mmHg).
| Arm | Type | Receives |
|---|---|---|
| Low Pressure Group | Experimental | Procedure: Pneumoperitoneum PressureParticipants will undergo elective bariatric surgery. Participants under this group will be given intra-abdominal pressure of 8-10mmHg. The number of subjects anticipated for this arm will be 47. Participants in this low pressure group are expected to encounter lesser shoulder tip pain and abdominal pain. Operating field for surgeons also expected to be better. |
| Standard Pressure Group | Experimental | Procedure: Pneumoperitoneum PressureParticipants will undergo elective bariatric surgery. Participants under this group will be given intra-abdominal pressure of 12-15mmHg. The number of subjects anticipated for this arm will be 47. Participants in this group are expected to have an increased amount of shoulder tip pain and higher pain score postoperatively compared to low pressure group. Operating fields for surgeons are expected to be less clear. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-70 years
- Ability to give informed consent
- Patients who are approved by the anaesthetics to undergo bariatric surgery.
Key exclusion criteria (5 listed)
- Age below 18 and above 70
- Inability to give informed consent
- Patient unfit for bariatric surgery including who has poor respiratory, cardiac, renal and liver function.
- Patient with Body Mass Index (BMI) >50
- Patient with American Society of Anesthesiologists (ASA) >3
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 |
|---|---|---|
| Pneumoperitoneum PressureThere will be two arms in this study. The participants recruited for this study are those who have been screened and planned for elective bariatric surgery.The pneumoperitoneum pressure will be adjusted to either 8-10mmHg or 12-15mmHg until a clear operating field is obtained by the surgeon. Low pneumoperitoneum pressure has been expected to give a clearer and better surgical view than standard pneumoperitoneum pressure. Participants under the low pressure group are expected to have lesser pain score on abdominal pain and shoulder tip pain as compared to participants in the standard pressure group. | Procedure or surgery | Low Pressure Group, Standard Pressure Group |
Primary outcome
Operating Field
Time frame: It will be assessed intraoperatively (during the surgery).
Numeric rating score will be used to access the operating field during the surgery. The numeric rating score will be recorded after the surgery by the surgeon. The score ranges from 1 to 4 whereby 1 means poor space with excessive muscular contractions and unable to proceed with surgery safely. Numeric rating scale of 4 indicates good surgical space. If there was any compromise of the operating field (NOS score ≥ 3), the pneumoperitoneum pressure will be increased accordingly.
2 secondary outcomes
Pain Score
Time frame: The abdomen and shoulder tip pain intensity will be rated up to 48 hours postoperatively.
Duration of Surgery
Time frame: The starting of surgery will be regarded after the induction of anaesthesia and the end of surgery is regarded when the end of skin closure.
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 7 May 2018.
- Background: PubMed 24977638Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Lindekaer AL, Riber C, Gatke MR. Surgical space conditions during low-pressure laparoscopic cholecystectomy with deep versus moderate neuromuscular blockade: a randomized clinical study. Anesth Analg. 2014 Nov;119(5):1084-92. doi: 10.1213/ANE.0000000000000316.
- Background: PubMed 12015619Neudecker J, Sauerland S, Neugebauer E, Bergamaschi R, Bonjer HJ, Cuschieri A, Fuchs KH, Jacobi Ch, Jansen FW, Koivusalo AM, Lacy A, McMahon MJ, Millat B, Schwenk W. The European Association for Endoscopic Surgery clinical practice guideline on the pneumoperitoneum for laparoscopic surgery. Surg Endosc. 2002 Jul;16(7):1121-43. doi: 10.1007/s00464-001-9166-7. Epub 2001 May 20.
- Background: PubMed 9876740Litynski GS. Kurt Semm and an automatic insufflator. JSLS. 1998 Apr-Jun;2(2):197-200.
- Background: PubMed 16749570Ibraheim OA, Samarkandi AH, Alshehry H, Faden A, Farouk EO. Lactate and acid base changes during laparoscopic cholecystectomy. Middle East J Anaesthesiol. 2006 Feb;18(4):757-68.
- Background: PubMed 15136925Schietroma M, Carlei F, Mownah A, Franchi L, Mazzotta C, Sozio A, Amicucci G. Changes in the blood coagulation, fibrinolysis, and cytokine profile during laparoscopic and open cholecystectomy. Surg Endosc. 2004 Jul;18(7):1090-6. doi: 10.1007/s00464-003-8819-0. Epub 2004 May 12.
- Background: PubMed 17043939Esmat ME, Elsebae MM, Nasr MM, Elsebaie SB. Combined low pressure pneumoperitoneum and intraperitoneal infusion of normal saline for reducing shoulder tip pain following laparoscopic cholecystectomy. World J Surg. 2006 Nov;30(11):1969-73. doi: 10.1007/s00268-005-0752-z.
- Background: PubMed 27073301Schietroma M, Pessia B, Stifini D, Lancione L, Carlei F, Cecilia EM, Amicucci G. Effects of low and standard intra-abdominal pressure on systemic inflammation and immune response in laparoscopic adrenalectomy: A prospective randomised study. J Minim Access Surg. 2016 Apr-Jun;12(2):109-17. doi: 10.4103/0972-9941.178513.
- Background: PubMed 24639018Gurusamy KS, Vaughan J, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 18;2014(3):CD006930. doi: 10.1002/14651858.CD006930.pub3.
- Background: PubMed 15650630Nguyen NT, Wolfe BM. The physiologic effects of pneumoperitoneum in the morbidly obese. Ann Surg. 2005 Feb;241(2):219-26. doi: 10.1097/01.sla.0000151791.93571.70.
- 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 11578282Gupta A, Watson DI. Effect of laparoscopy on immune function. Br J Surg. 2001 Oct;88(10):1296-306. doi: 10.1046/j.0007-1323.2001.01860.x.
- Background: PubMed 15619524Sylla P, Kirman I, Whelan RL. Immunological advantages of advanced laparoscopy. Surg Clin North Am. 2005 Feb;85(1):1-18, vii. doi: 10.1016/j.suc.2004.09.005.
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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.
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 Pneumoperitoneum Pressure in people with Surgical View and Shoulder Tip Pain, run by Universiti Putra Malaysia at 1 site in Malaysia.
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 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 7 May 2018. 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 Malaysia. 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?
Operating Field (time frame: It will be assessed intraoperatively (during the 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 NCT03179111, which also lists 37 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 7 May 2018.