Bidirectional EndoscopyNCT04973878
The Optimal Sequence in Same-day Bidirectional Endoscopy Under Deep Anesthesia.
A study testing EGD first and Colonoscopy first in people with Bidirectional Endoscopy and Deep Sedation, run by Ruijin Hospital.
Trial summary
The purpose of this study is to explore the optimal sequence of same-day bidirectional endoscopy under deep anesthesia induced by propofol combined with fentanyl. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bidirectional Endoscopy, Deep Sedation
- What is being tested?
- EGD first and Colonoscopy first
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 544 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2021to 30 Jul 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient with a clinical indication for receiving same day bi-directional endoscopies.
Who cannot join
- Contraindications of colonoscopy: acute peritonitis; intestinal perforation or suspected intestinal perforation; acute anorectal infection or painful lesions; menstruation; pregnancy; cardiopulmonary insufficiency; prior abdominal and pelvic surgery.
- Contraindications for EGD: severe heart disease, severe heart failure; severe lung disease: asthma : severe hypertension; acute perforation of esophagus, stomach and duodenum; acute severe pharynx and larynx disease gastroscopy can not be inserted; acute stage of corrosive esophageal injury; prior upper digestive tract operation.
- Contraindications for oral intestinal laxative: severe gastrointestinal obstruction or stricture; toxic megacolon; severe acute intestinal infection; dysphagia; disturbance of consciousness; allergy to drug ingredients.
- Allergic to emulsions or opioids.
- ASA score ≥ III
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Optimal Sequence in Same-day Bidirectional Endoscopy Under Deep Anesthesia Induced by Propofol Combined With Fentanyl: A Prospective Randomized Controlled ,Two Centers Trial
The purpose of this study is to explore the optimal sequence of same-day bidirectional endoscopy under deep anesthesia induced by propofol combined with fentanyl.
Read the detailed description
Same-day bidirectional endoscopy are commonly performed to evaluate iron deficiency anemia, positive fecal occult blood, abdominal pain and cancer screening. In order to reducing intraoperative pain, providing better operating conditions and improving the endoscopic examination quality, endoscopy with anesthesia assistance has gradually become the choice of more patients. However, the optimal sequence of procedures for same-day bidirectional endoscopy has not been established. This is a two-center, single-blind, randomized, controlled trial. Patients undergoing same-day bidirectional endoscopy under deep sedation will be randomly assigned to either the colonoscopy-first group (colonoscopy followed by EGD, n = 272) or the EGD(esophagogastroduodenoscopy)-first group (EGD followed by colonoscopy, n = 272).The detection rate of adenoma（ADR）, the ADR of right-side colon , Boston score of right-side colon, total dose of anesthetics, operation time, recovery time, adverse events and patient satisfaction will be evaluated.
- Conditions
- Bidirectional Endoscopy, Deep Sedation
- Being tested
- EGD first, Colonoscopy first
- Keywords
- Bidirectional Endoscopy, Deep Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGD firstProcedure or surgery
In this group, patients receiving an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients receive deep sedation with propofol and fentanyl.
Colonoscopy firstProcedure or surgery
In this group, patients receiving a colonoscopy followed by EGD during a same-day bidirectional endoscopy. Patients receive deep sedation with propofol and fentanyl.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | EGD performed before the Colonoscopy Receives: Procedure: EGD first |
| Group B | Experimental | Colonoscopy performed before the EGD Receives: Procedure: Colonoscopy first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate
Adenoma detection rate is the proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas detected. In this study, ADR during the colonoscopy will recorded.
Measured: 1 year
Adenoma Detection Rate of the right-sided colon
The ADR of right-sided colon will be recorded.Right -sided colon is refered to cecum, ascending colon and ileocecal junction.
Measured: 1 year
The boston bowel preparation scale of the right-sided colon
During colonoscopy, the boston bowel preparation scale of the right-sided colon will be recorded and compared between the two study groups.
Measured: 1 year
Secondary outcomes (5)
Sedation use
During bidirectional endoscopy, the total doses of propofol and fentanyl will be recorded.
Measured: 1 year
Overall Duration of BDE Examinations
The overall duration of both EGD and colonoscopy examinations will be recorded.
Measured: 1 year
Recovery time
Time between the end of the procedure and patient waken-up will be recorded.
Measured: 1 year
Adverse events
Intraprocedure adverse events will be documented (oxygen saturation <90% for >30 s, systolic blood pressure drop for 30 %, and heart rate <50 or >120 beats/min lasting >30 s).
Measured: 1 year
Overall patient satisfaction
Patient satisfaction will be assessed after the procedures using 10-cm visual analog scale.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start30 Jul 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Bidirectional EndoscopyStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients undergoing same-day bidirectional endoscopy under deep sedation will be randomly assigned to either the colonoscopy-first group (colonoscopy followed by EGD, n = 272) or the EGD-first group (EGD followed by colonoscopy, n = 272).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 544 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Soochow University
- Responsible party
- Principal investigator, duowu zou, Ruijin Hospital
- Investigators
- Duowu Zou, Ph.D,M.D, Study chair, Ruijin hospital Shanghai Jiaotong Universtity, school of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04973878
- Sponsor's protocol ID
- RuijinH2021131
- Status last verified
- Jul 2021
- First submitted
- 17 Jul 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Urquhart J, Eisen G, Faigel DO, Mattek N, Holub J, Lieberman DA. A closer look at same-day bidirectional endoscopy. Gastrointest Endosc. 2009 Feb;69(2):271-7. doi: 10.1016/j.gie.2008.04.063. Epub 2008 Aug 23.
PubMed 18725159Cairns SR, Scholefield JH, Steele RJ, Dunlop MG, Thomas HJ, Evans GD, Eaden JA, Rutter MD, Atkin WP, Saunders BP, Lucassen A, Jenkins P, Fairclough PD, Woodhouse CR; British Society of Gastroenterology; Association of Coloproctology for Great Britain and Ireland. Guidelines for colorectal cancer screening and surveillance in moderate and high risk groups (update from 2002). Gut. 2010 May;59(5):666-89. doi: 10.1136/gut.2009.179804.
PubMed 20427401Lucendo AJ, Arias A, Gonzalez-Castillo S, Angueira T, Guagnozzi D, Fernandez-Fuente M, Serrano-Valverde M, Sanchez-Cazalilla M, Chumillas O, Fernandez-Ordonez M, Tenias JM. Same-day bidirectional endoscopy with nonanesthesiologist administration of propofol: safety and cost-effectiveness compared with separated exams. Eur J Gastroenterol Hepatol. 2014 Mar;26(3):301-8. doi: 10.1097/MEG.0000000000000026.
PubMed 24365718Yang C, Sriranjan V, Abou-Setta AM, Poluha W, Walker JR, Singh H. Anxiety Associated with Colonoscopy and Flexible Sigmoidoscopy: A Systematic Review. Am J Gastroenterol. 2018 Dec;113(12):1810-1818. doi: 10.1038/s41395-018-0398-8. Epub 2018 Nov 1.
PubMed 30385831Lu Y, Hao LX, Chen L, Jin Z, Gong B. Systematic review and meta-analysis of patient-controlled sedation versus intravenous sedation for colonoscopy. Int J Clin Exp Med. 2015 Nov 15;8(11):19793-803. eCollection 2015.
PubMed 26884890Igea F, Casellas JA, Gonzalez-Huix F, Gomez-Oliva C, Baudet JS, Cacho G, Simon MA, De la Morena E, Lucendo A, Vida F; Spanish Society of Digestive Endoscopy. Sedation for gastrointestinal endoscopy. Endoscopy. 2014 Aug;46(8):720-31. doi: 10.1055/s-0034-1377561. Epub 2014 Jul 25. No abstract available.
PubMed 25061964Bugajski M, Wieszczy P, Hoff G, Rupinski M, Regula J, Kaminski MF. Modifiable factors associated with patient-reported pain during and after screening colonoscopy. Gut. 2018 Nov;67(11):1958-1964. doi: 10.1136/gutjnl-2017-313905. Epub 2017 Sep 28.
PubMed 28970289Grocott HP. Propofol sedation improves efficiency and optimizes patient satisfaction during colonoscopy. CMAJ. 2018 Jun 18;190(24):E751. doi: 10.1503/cmaj.69279. No abstract available.
PubMed 29914915Wadhwa V, Issa D, Garg S, Lopez R, Sanaka MR, Vargo JJ. Similar Risk of Cardiopulmonary Adverse Events Between Propofol and Traditional Anesthesia for Gastrointestinal Endoscopy: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2017 Feb;15(2):194-206. doi: 10.1016/j.cgh.2016.07.013. Epub 2016 Jul 21.
PubMed 27451091Cao Y, Yang J, Li J, Ao X, Zhang KY, Shen XC, Chen DF, Lan CH. Comparison of procedural sequences in same-day painless bidirectional endoscopy: Single-center, prospective, randomized study. Dig Endosc. 2017 May;29(3):330-337. doi: 10.1111/den.12847. Epub 2017 Mar 30.
PubMed 28211094Hsieh YH, Lin HJ, Tseng KC. Which should go first during same-day bidirectional endosocopy with propofol sedation? J Gastroenterol Hepatol. 2011 Oct;26(10):1559-64. doi: 10.1111/j.1440-1746.2011.06786.x.
PubMed 21615790Hammami MB, Reddy KM, Pandit P, Chahla EJ, Koro N, Schuelke MJ, Hachem C. Sequence of same-day upper and lower gastrointestinal endoscopy does not affect total procedure' time or medication use: A randomized trial. JGH Open. 2019 Aug 6;3(6):488-493. doi: 10.1002/jgh3.12203. eCollection 2019 Dec.
PubMed 31832549Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Gastrointest Endosc. 2015 Jan;81(1):31-53. doi: 10.1016/j.gie.2014.07.058. Epub 2014 Dec 2. No abstract available.
PubMed 25480100Chokshi RV, Hovis CE, Hollander T, Early DS, Wang JS. Prevalence of missed adenomas in patients with inadequate bowel preparation on screening colonoscopy. Gastrointest Endosc. 2012 Jun;75(6):1197-203. doi: 10.1016/j.gie.2012.01.005. Epub 2012 Feb 28.
PubMed 22381531
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Sequence in Same-day Bidirectional Endoscopy Under Deep Anesthesia Induced by Propofol Combined With Fentanyl: A Prospective Randomized Controlled ,Two Centers Trial
- ClinicalTrials.gov ID
- NCT04973878
- Acronym / sponsor ID
- RuijinH2021131
- Conditions
- Bidirectional Endoscopy, Deep Sedation
- Keywords
- Bidirectional Endoscopy, Deep Sedation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 544 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Soochow University
- Study start
- 30 Jul 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 22 Jul 2021 (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 explore the optimal sequence of same-day bidirectional endoscopy under deep anesthesia induced by propofol combined with fentanyl.
Detailed description
Same-day bidirectional endoscopy are commonly performed to evaluate iron deficiency anemia, positive fecal occult blood, abdominal pain and cancer screening. In order to reducing intraoperative pain, providing better operating conditions and improving the endoscopic examination quality, endoscopy with anesthesia assistance has gradually become the choice of more patients. However, the optimal sequence of procedures for same-day bidirectional endoscopy has not been established. This is a two-center, single-blind, randomized, controlled trial. Patients undergoing same-day bidirectional endoscopy under deep sedation will be randomly assigned to either the colonoscopy-first group (colonoscopy followed by EGD, n = 272) or the EGD(esophagogastroduodenoscopy)-first group (EGD followed by colonoscopy, n = 272).The detection rate of adenoma（ADR）, the ADR of right-side colon , Boston score of right-side colon, total dose of anesthetics, operation time, recovery time, adverse events and patient satisfaction will be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients undergoing same-day bidirectional endoscopy under deep sedation will be randomly assigned to either the colonoscopy-first group (colonoscopy followed by EGD, n = 272) or the EGD-first group (EGD followed by colonoscopy, n = 272).
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: EGD firstEGD performed before the Colonoscopy |
| Group B | Experimental | Procedure: Colonoscopy firstColonoscopy performed before the EGD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient with a clinical indication for receiving same day bi-directional endoscopies.
Key exclusion criteria (5 listed)
- Contraindications of colonoscopy: acute peritonitis; intestinal perforation or suspected intestinal perforation; acute anorectal infection or painful lesions; menstruation; pregnancy; cardiopulmonary insufficiency; prior abdominal and pelvic surgery.
- Contraindications for EGD: severe heart disease, severe heart failure; severe lung disease: asthma : severe hypertension; acute perforation of esophagus, stomach and duodenum; acute severe pharynx and larynx disease gastroscopy can not be inserted; acute stage of corrosive esophageal injury; prior upper digestive tract operation.
- Contraindications for oral intestinal laxative: severe gastrointestinal obstruction or stricture; toxic megacolon; severe acute intestinal infection; dysphagia; disturbance of consciousness; allergy to drug ingredients.
- Allergic to emulsions or opioids.
- ASA score ≥ III
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 |
|---|---|---|
| EGD firstIn this group, patients receiving an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients receive deep sedation with propofol and fentanyl. | Procedure or surgery | Group A |
| Colonoscopy firstIn this group, patients receiving a colonoscopy followed by EGD during a same-day bidirectional endoscopy. Patients receive deep sedation with propofol and fentanyl. | Procedure or surgery | Group B |
Primary outcome
Adenoma Detection Rate
Time frame: 1 year
Adenoma detection rate is the proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas detected. In this study, ADR during the colonoscopy will recorded.
Adenoma Detection Rate of the right-sided colon
Time frame: 1 year
The ADR of right-sided colon will be recorded.Right -sided colon is refered to cecum, ascending colon and ileocecal junction.
The boston bowel preparation scale of the right-sided colon
Time frame: 1 year
During colonoscopy, the boston bowel preparation scale of the right-sided colon will be recorded and compared between the two study groups.
5 secondary outcomes
Sedation use
Time frame: 1 year
Overall Duration of BDE Examinations
Time frame: 1 year
Recovery time
Time frame: 1 year
Adverse events
Time frame: 1 year
Overall patient satisfaction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Background: PubMed 18725159Urquhart J, Eisen G, Faigel DO, Mattek N, Holub J, Lieberman DA. A closer look at same-day bidirectional endoscopy. Gastrointest Endosc. 2009 Feb;69(2):271-7. doi: 10.1016/j.gie.2008.04.063. Epub 2008 Aug 23.
- Background: PubMed 20427401Cairns SR, Scholefield JH, Steele RJ, Dunlop MG, Thomas HJ, Evans GD, Eaden JA, Rutter MD, Atkin WP, Saunders BP, Lucassen A, Jenkins P, Fairclough PD, Woodhouse CR; British Society of Gastroenterology; Association of Coloproctology for Great Britain and Ireland. Guidelines for colorectal cancer screening and surveillance in moderate and high risk groups (update from 2002). Gut. 2010 May;59(5):666-89. doi: 10.1136/gut.2009.179804.
- Background: PubMed 24365718Lucendo AJ, Arias A, Gonzalez-Castillo S, Angueira T, Guagnozzi D, Fernandez-Fuente M, Serrano-Valverde M, Sanchez-Cazalilla M, Chumillas O, Fernandez-Ordonez M, Tenias JM. Same-day bidirectional endoscopy with nonanesthesiologist administration of propofol: safety and cost-effectiveness compared with separated exams. Eur J Gastroenterol Hepatol. 2014 Mar;26(3):301-8. doi: 10.1097/MEG.0000000000000026.
- Background: PubMed 30385831Yang C, Sriranjan V, Abou-Setta AM, Poluha W, Walker JR, Singh H. Anxiety Associated with Colonoscopy and Flexible Sigmoidoscopy: A Systematic Review. Am J Gastroenterol. 2018 Dec;113(12):1810-1818. doi: 10.1038/s41395-018-0398-8. Epub 2018 Nov 1.
- Background: PubMed 26884890Lu Y, Hao LX, Chen L, Jin Z, Gong B. Systematic review and meta-analysis of patient-controlled sedation versus intravenous sedation for colonoscopy. Int J Clin Exp Med. 2015 Nov 15;8(11):19793-803. eCollection 2015.
- Background: PubMed 25061964Igea F, Casellas JA, Gonzalez-Huix F, Gomez-Oliva C, Baudet JS, Cacho G, Simon MA, De la Morena E, Lucendo A, Vida F; Spanish Society of Digestive Endoscopy. Sedation for gastrointestinal endoscopy. Endoscopy. 2014 Aug;46(8):720-31. doi: 10.1055/s-0034-1377561. Epub 2014 Jul 25. No abstract available.
- Background: PubMed 28970289Bugajski M, Wieszczy P, Hoff G, Rupinski M, Regula J, Kaminski MF. Modifiable factors associated with patient-reported pain during and after screening colonoscopy. Gut. 2018 Nov;67(11):1958-1964. doi: 10.1136/gutjnl-2017-313905. Epub 2017 Sep 28.
- Background: PubMed 29914915Grocott HP. Propofol sedation improves efficiency and optimizes patient satisfaction during colonoscopy. CMAJ. 2018 Jun 18;190(24):E751. doi: 10.1503/cmaj.69279. No abstract available.
- Background: PubMed 27451091Wadhwa V, Issa D, Garg S, Lopez R, Sanaka MR, Vargo JJ. Similar Risk of Cardiopulmonary Adverse Events Between Propofol and Traditional Anesthesia for Gastrointestinal Endoscopy: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2017 Feb;15(2):194-206. doi: 10.1016/j.cgh.2016.07.013. Epub 2016 Jul 21.
- Background: PubMed 28211094Cao Y, Yang J, Li J, Ao X, Zhang KY, Shen XC, Chen DF, Lan CH. Comparison of procedural sequences in same-day painless bidirectional endoscopy: Single-center, prospective, randomized study. Dig Endosc. 2017 May;29(3):330-337. doi: 10.1111/den.12847. Epub 2017 Mar 30.
- Background: PubMed 21615790Hsieh YH, Lin HJ, Tseng KC. Which should go first during same-day bidirectional endosocopy with propofol sedation? J Gastroenterol Hepatol. 2011 Oct;26(10):1559-64. doi: 10.1111/j.1440-1746.2011.06786.x.
- Background: PubMed 31832549Hammami MB, Reddy KM, Pandit P, Chahla EJ, Koro N, Schuelke MJ, Hachem C. Sequence of same-day upper and lower gastrointestinal endoscopy does not affect total procedure' time or medication use: A randomized trial. JGH Open. 2019 Aug 6;3(6):488-493. doi: 10.1002/jgh3.12203. eCollection 2019 Dec.
- Individual participant dataSharing planned: Undecided
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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.
Duowu Zou, Ph.D,M.D study chair
Ruijin hospital Shanghai Jiaotong Universtity, school of medicine
Questions about this trial
What is this clinical trial studying?
A study testing EGD first and Colonoscopy first in people with Bidirectional Endoscopy and Deep Sedation, run by Ruijin Hospital.
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 1 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: status not confirmed, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Duowu Zou, Ph.D,M.D (+86 13901617608, zdw_pi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma Detection Rate (time frame: 1 year). The study lists 3 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 NCT04973878, which also lists 14 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 Jul 2021.