Procedure TimeNCT04473456
Combined Simultaneous EGD-colonoscopy Trial (CoSi Endoscopy)
A study testing Simultaneous EGD and colonoscopy in people with Procedure Time, run by EmuraCenter LatinoAmerica at 1 site in Colombia.
Trial summary
The COVID -19 pandemic has reduced endoscopy services to an average of 83% producing a significant economic impact on endoscopy units worldwide. Endoscopy as an aerosol-generating procedure requires endoscopy units to allow 12 cycles of air exchange per hour, equivalent to 20 minutes, between patients, to reduce… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedure Time
- What is being tested?
- Simultaneous EGD and colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteColombia
- Study dates
- 13 Jun 2020to 23 Sep 2020
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible patients are those scheduled for EGD and colonoscopy at EmuraCenter Latinoamerica, Bogota DC, Colombia between June and August 2020. Procedure indications: abdominal pain, chronic anemia, chronic diarrhea, cancer screening, gastrointestinal bleeding.
Who cannot join
- Exclusion criteria are inadequate bowel preparation with Boston score with at least 1 point in any segment, residual gastric food, previous surgery of the digestive tract, and refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Simultaneous EGD-colonoscopy (CoSi Endoscopy) Harmlessly Reduces Procedure Times: a Randomized Control Trial
The COVID -19 pandemic has reduced endoscopy services to an average of 83% producing a significant economic impact on endoscopy units worldwide. Endoscopy as an aerosol-generating procedure requires endoscopy units to allow 12 cycles of air exchange per hour, equivalent to 20 minutes, between patients, to reduce medical risk exposure. Planning strategies to facilitate economic reactivation of endoscopy services in a responsible manner, maintaining adequate security measures for both patients and healthcare personnel is currently a major challenge. Serial endoscopic interventions as esophagogastroduodenoscopy (EGD) and colonoscopy are commonly performed during the same sedation time. Estimated times for quality inspection in the upper digestive tract and the colon, are 7 and 6 minutes, respectively. In addition, time to reach the cecum and to set up the following procedure increase not only procedure time but SARS-CoV-2 exposure to healthcare personnel. Performing these two procedures simultaneously by two endoscopists would considerably reduce procedure time while increasing the number of patients evaluated in one day, especially in the period of service reactivation. There are no studies comparing simultaneous EGD and colonoscopy procedures and, serial procedures. This study aims to determine differences in procedures times between simultaneous EGD-colonoscopy and conventional serial EGD-colonoscopy as an alternative to improve the number of procedures/hour/unit during the COVID-19 era.
Read the detailed description
Study type:
This is a prospective controlled randomized study to determine differences in procedure times of simultaneous EGD-colonoscopy and serial EGD-colonoscopy. Patients are randomized into two groups: the serial group, where the EGD is performed first and thereafter the colonoscopy and, the simultaneous group, where the two procedures are performed at the same time, each by a trained gastroenterologist.
Patients:
Eligible patients are those consecutively scheduled for EGD and colonoscopy at EmuraCenter LatinoAmerica, Bogota DC, Colombia between June and August, 2020. Indications for procedures include among others abdominal pain, screening for digestive cancer, chronic anemia, digestive bleeding, and chronic diarrhea. Exclusion criteria are inadequate bowel preparation with Boston score with at least 1 point in any segment, residual gastric food, previous digestive system surgery, and refusal to participate. Patients and their accompanying person give written consent of the procedures and are asked to complete a telephone survey related to COVID-19 symptoms 1 day before the procedure and 30 minutes before the procedure.
Randomization:
Endoscopists participating in the study are experts endoscopists. In both groups, colonoscopies are performed by the same expert endoscopist. EGD in the serial group is performed by the attending endoscopist responsible for procedures that day.
Outcomes:
Variables to be compared between groups include unit entry's time, time to completion of both procedures, EGD time, EGD inspection time, colonoscopy time, time to teach the cecum, withdrawal time, inter-procedure time, unit's exit time, the dose of sedation agent and endoscopic findings. Oxygenation (pO2) and percutaneous pCo2 are evaluated 5 minutes before, 5, and 10 minutes during the procedure and 5 minutes after completing the last procedure. A trained physician or anesthesiologist will administrate sedation to patients using Propofol. Post-procedure symptoms will be assessed by written survey 30 minutes and 24 hours after the procedure. This survey evaluates 6 symptoms, 3 of which are related to sedation: Nausea, drowsiness, and dizziness. and, the other 3 symptoms are related to the endoscopic procedure: abdominal pain, bloating, and pharyngeal pain. Each of the 6 symptoms will be scored from 1 to 5 (1: None, 2: Mild, 3: Moderate, 4: Severe, and 5: Extreme).
Patient position and location of endoscopy systems:
All patients are positioned in the left lateral decubitus position. For simultaneous procedures, the EGD tower is located to the left side and the colonoscopy tower at the right side of the bedside at the level patient's head.
EGD:
The systematic complete photodocumentation approach proposed by Emura et al will be carried out to inspect the upper GI tract mucosa using a Fuji 7000 video processor and a Fuji Lasereo EG-760 gastroscope. BLI-bright digital chromoendoscopy will be performed to observe the hypopharynx, the esophagus, and the esophagogastric junction and, the LCI mode for evaluation of the stomach and duodenal mucosa. Low CO2 insufflation will be used using the Fuji GW-100 insufflator.
Colonoscopy in the serial group:
A Fuji Lasereo 7000 equipment and an EC-760ZP-V / L colonoscope will be used. The CO2 insufflation will be carried out with Fuji GW-100 equipment.
Colonoscopy in the parallel-group:
An Olympus Evis Exera II equipment and an H-180-AI colonoscope will be used. An Olympus UCR insufflator will be used for CO2 insufflation.
Transcutaneous measurement of pCo2:
The pCO2 measurements will be performed using a Tosca TCM kit (XLab Solutions). This equipment uses a transducer (ts sensor 54) that is positioned on the patient's arm and measures pCO2 non-invasively.
- Conditions
- Procedure Time
- Being tested
- Simultaneous EGD and colonoscopy
- Keywords
- Combined simultaneous (CoSi) endoscopy, EGD, Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous EGD and colonoscopyProcedure or surgery
Patients are examined simultaneously by EGD and colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Serial arm | No intervention | In the serial group, all colonoscopies will be performed by the same endoscopist. EGDs are performed by the attending endoscopist on the day of the procedure. |
| Simultaneous arm | Active comparator | In the simultaneous group, all colonoscopies will be performed by the same endoscopist. EGDs are performed by the attending endoscopist on the day of the procedure. Receives: Procedure: Simultaneous EGD and colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedures time
Time elapsed in minutes between the starting of the first procedure and the ending time of the second procedure in the serial arm or both procedures in the simultaneous arm.
Measured: Time elapsed in minutes between the starting of the first procedure and the ending time of the second procedure in the serial arm or both procedures in the simultaneous arm.
Interprocedure time
Time elapsed in minutes between the end of the first procedure and the starting of the second procedure (only applies in serial arm)
Measured: Time elapsed in minutes between the end of the first procedure and the starting of the second procedure (only applies in serial arm)
Upper GI inspection time
Time taken in minutes to inspect the entire upper GI mucosa according to the complete photodocumentation method proposed by Emura et al.
Measured: Time taken in minutes to inspect the entire upper GI mucosa according to the complete photodocumentation method proposed by Emura et al.
Colonoscopy withdrawal time
Time elapsed in minutes between the cecum and the lower rectum used to inspect the colorectal mucosa
Measured: Time elapsed in minutes between the cecum and the lower rectum used to inspect the colorectal mucosa
Colonoscopy insertion time
Time elapsed in minutes to reach the cecum
Measured: Time elapsed in minutes to reach the cecum
EGD time
Time elapsed in minutes between the insertion of the gastroscope into the mouth and the extraction from the mouth
Measured: Time elapsed in minutes between the insertion of the gastroscope into the mouth and the extraction from the mouth
Colonoscopy time
Time elapsed in minutes between the insertion of the colonoscope into the lower rectum and the extraction from the lower rectum
Measured: Time elapsed in minutes between the insertion of the colonoscope into the lower rectum and the extraction from the lower rectum
Propofol used in EGD
Amount in mg of Propofol used during EGD
Measured: Amount in mg of Propofol used during EGD
Propofol used in colonoscopy
Amount in mg of Propofol used during colonoscopy
Measured: Amount in mg of Propofol used during colonoscopy
Propofol used in EGD and colonoscopy
Amount of Propofol in mg used fro procedures in the simultaneous arm.
Measured: Amount of Propofol in mg used fro procedures in the simultaneous arm
percutaneous pCO2
Measurement of pCO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.
Measured: Measurement of pCO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.
percutaneous pO2
Measurement of pO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.
Measured: Measurement of pO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.
Position change 1
Change of patient's position during colonoscopy. Yes or No answer
Measured: During colonoscopy
Position change 2
If occurred, how many times the position changed. Numerical variable.
Measured: During olonoscopy
Post procedure symptoms survey related to colonoscopy
Nausea, drowsiness, and dizziness are scored by patients using a scale from 1 to 5 (1: None, 2: Mild, 3: Moderate, 4: Severe, and 5: Extreme).
Measured: 20 minutes after the last procedure and after 24 hours
Post procedure symptoms survey related to sedation
Abdominal pain, bloating, and pharyngeal pain are scored by patients using a scale from 1 to 5 (1: None, 2: Mild, 3: Moderate, 4: Severe, and 5: Extreme).
Measured: 20 minutes after the last procedure and after 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start13 Jun 2020
- Primary completion22 Sep 2020
- Study completion23 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Procedure TimeStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomly assigned to non-intervention and intervention (simultaneous EGD and colonoscopy) arms
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- EmuraCenter LatinoAmerica
- Sponsor type
- Research network
- Collaborators
- Universidad de la Sabana
- Responsible party
- Sponsor
- Investigators
- FABIAN EMURA, PhD, Principal investigator, EmuraCenter LatinoAmerica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473456
- Sponsor's protocol ID
- 2020-ECL-6-1
- Status last verified
- Dec 2020
- First submitted
- 13 Jul 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is s plan to share IPD with other researchers
Publications
Emura F, Sharma P, Arantes V, Cerisoli C, Parra-Blanco A, Sumiyama K, Araya R, Sobrino S, Chiu P, Matsuda K, Gonzalez R, Fujishiro M, Tajiri H. Principles and practice to facilitate complete photodocumentation of the upper gastrointestinal tract: World Endoscopy Organization position statement. Dig Endosc. 2020 Jan;32(2):168-179. doi: 10.1111/den.13530. Epub 2019 Nov 6.
PubMed 31529547Parasa S, Reddy N, Faigel DO, Repici A, Emura F, Sharma P. Global Impact of the COVID-19 Pandemic on Endoscopy: An International Survey of 252 Centers From 55 Countries. Gastroenterology. 2020 Oct;159(4):1579-1581.e5. doi: 10.1053/j.gastro.2020.06.009. Epub 2020 Jun 11. No abstract available.
PubMed 32534934Guda NM, Emura F, Reddy DN, Rey JF, Seo DW, Gyokeres T, Tajiri H, Faigel D. Recommendations for the Operation of Endoscopy Centers in the setting of the COVID-19 pandemic - World Endoscopy Organization guidance document. Dig Endosc. 2020 Sep;32(6):844-850. doi: 10.1111/den.13777. Epub 2020 Aug 12.
PubMed 32569438Bisschops R, Areia M, Coron E, Dobru D, Kaskas B, Kuvaev R, Pech O, Ragunath K, Weusten B, Familiari P, Domagk D, Valori R, Kaminski MF, Spada C, Bretthauer M, Bennett C, Senore C, Dinis-Ribeiro M, Rutter MD. Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2016 Sep;48(9):843-64. doi: 10.1055/s-0042-113128. Epub 2016 Aug 22. No abstract available.
PubMed 27548885Trencheva K, Dhar P, Sonoda T, Lee S, Samuels J, Stein B, Milsom J. Physiologic effects of simultaneous carbon dioxide insufflation by laparoscopy and colonoscopy: prospective evaluation. Surg Endosc. 2011 Oct;25(10):3279-85. doi: 10.1007/s00464-011-1705-2. Epub 2011 May 24.
PubMed 21607827
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Simultaneous EGD-colonoscopy (CoSi Endoscopy) Harmlessly Reduces Procedure Times: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04473456
- Acronym / sponsor ID
- 2020-ECL-6-1
- Conditions
- Procedure Time
- Keywords
- Combined simultaneous (CoSi) endoscopy, EGD, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- EmuraCenter LatinoAmericaResearch network
- Collaborators
- Universidad de la Sabana
- Study start
- 13 Jun 2020 (actual)
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 16 Jul 2020 (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 COVID -19 pandemic has reduced endoscopy services to an average of 83% producing a significant economic impact on endoscopy units worldwide. Endoscopy as an aerosol-generating procedure requires endoscopy units to allow 12 cycles of air exchange per hour, equivalent to 20 minutes, between patients, to reduce medical risk exposure. Planning strategies to facilitate economic reactivation of endoscopy services in a responsible manner, maintaining adequate security measures for both patients and healthcare personnel is currently a major challenge. Serial endoscopic interventions as esophagogastroduodenoscopy (EGD) and colonoscopy are commonly performed during the same sedation time. Estimated times for quality inspection in the upper digestive tract and the colon, are 7 and 6 minutes, respectively. In addition, time to reach the cecum and to set up the following procedure increase not only procedure time but SARS-CoV-2 exposure to healthcare personnel. Performing these two procedures simultaneously by two endoscopists would considerably reduce procedure time while increasing the number of patients evaluated in one day, especially in the period of service reactivation. There are no studies comparing simultaneous EGD and colonoscopy procedures and, serial procedures. This study aims to determine differences in procedures times between simultaneous EGD-colonoscopy and conventional serial EGD-colonoscopy as an alternative to improve the number of procedures/hour/unit during the COVID-19 era.
Detailed description
Study type:
This is a prospective controlled randomized study to determine differences in procedure times of simultaneous EGD-colonoscopy and serial EGD-colonoscopy. Patients are randomized into two groups: the serial group, where the EGD is performed first and thereafter the colonoscopy and, the simultaneous group, where the two procedures are performed at the same time, each by a trained gastroenterologist.
Patients:
Eligible patients are those consecutively scheduled for EGD and colonoscopy at EmuraCenter LatinoAmerica, Bogota DC, Colombia between June and August, 2020. Indications for procedures include among others abdominal pain, screening for digestive cancer, chronic anemia, digestive bleeding, and chronic diarrhea. Exclusion criteria are inadequate bowel preparation with Boston score with at least 1 point in any segment, residual gastric food, previous digestive system surgery, and refusal to participate. Patients and their accompanying person give written consent of the procedures and are asked to complete a telephone survey related to COVID-19 symptoms 1 day before the procedure and 30 minutes before the procedure.
Randomization:
Endoscopists participating in the study are experts endoscopists. In both groups, colonoscopies are performed by the same expert endoscopist. EGD in the serial group is performed by the attending endoscopist responsible for procedures that day.
Outcomes:
Variables to be compared between groups include unit entry's time, time to completion of both procedures, EGD time, EGD inspection time, colonoscopy time, time to teach the cecum, withdrawal time, inter-procedure time, unit's exit time, the dose of sedation agent and endoscopic findings. Oxygenation (pO2) and percutaneous pCo2 are evaluated 5 minutes before, 5, and 10 minutes during the procedure and 5 minutes after completing the last procedure. A trained physician or anesthesiologist will administrate sedation to patients using Propofol. Post-procedure symptoms will be assessed by written survey 30 minutes and 24 hours after the procedure. This survey evaluates 6 symptoms, 3 of which are related to sedation: Nausea, drowsiness, and dizziness. and, the other 3 symptoms are related to the endoscopic procedure: abdominal pain, bloating, and pharyngeal pain. Each of the 6 symptoms will be scored from 1 to 5 (1: None, 2: Mild, 3: Moderate, 4: Severe, and 5: Extreme).
Patient position and location of endoscopy systems:
All patients are positioned in the left lateral decubitus position. For simultaneous procedures, the EGD tower is located to the left side and the colonoscopy tower at the right side of the bedside at the level patient's head.
EGD:
The systematic complete photodocumentation approach proposed by Emura et al will be carried out to inspect the upper GI tract mucosa using a Fuji 7000 video processor and a Fuji Lasereo EG-760 gastroscope. BLI-bright digital chromoendoscopy will be performed to observe the hypopharynx, the esophagus, and the esophagogastric junction and, the LCI mode for evaluation of the stomach and duodenal mucosa. Low CO2 insufflation will be used using the Fuji GW-100 insufflator.
Colonoscopy in the serial group:
A Fuji Lasereo 7000 equipment and an EC-760ZP-V / L colonoscope will be used. The CO2 insufflation will be carried out with Fuji GW-100 equipment.
Colonoscopy in the parallel-group:
An Olympus Evis Exera II equipment and an H-180-AI colonoscope will be used. An Olympus UCR insufflator will be used for CO2 insufflation.
Transcutaneous measurement of pCo2:
The pCO2 measurements will be performed using a Tosca TCM kit (XLab Solutions). This equipment uses a transducer (ts sensor 54) that is positioned on the patient's arm and measures pCO2 non-invasively.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomly assigned to non-intervention and intervention (simultaneous EGD and colonoscopy) arms
| Arm | Type | Receives |
|---|---|---|
| Serial arm | No intervention | –In the serial group, all colonoscopies will be performed by the same endoscopist. EGDs are performed by the attending endoscopist on the day of the procedure. |
| Simultaneous arm | Active comparator | Procedure: Simultaneous EGD and colonoscopyIn the simultaneous group, all colonoscopies will be performed by the same endoscopist. EGDs are performed by the attending endoscopist on the day of the procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients are those scheduled for EGD and colonoscopy at EmuraCenter Latinoamerica, Bogota DC, Colombia between June and August 2020. Procedure indications: abdominal pain, chronic anemia, chronic diarrhea, cancer screening, gastrointestinal bleeding.
Key exclusion criteria (1 listed)
- Exclusion criteria are inadequate bowel preparation with Boston score with at least 1 point in any segment, residual gastric food, previous surgery of the digestive tract, and refusal to participate.
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 |
|---|---|---|
| Simultaneous EGD and colonoscopyPatients are examined simultaneously by EGD and colonoscopy | Procedure or surgery | Simultaneous arm |
Primary outcome
Procedures time
Time frame: Time elapsed in minutes between the starting of the first procedure and the ending time of the second procedure in the serial arm or both procedures in the simultaneous arm.
Time elapsed in minutes between the starting of the first procedure and the ending time of the second procedure in the serial arm or both procedures in the simultaneous arm.
Interprocedure time
Time frame: Time elapsed in minutes between the end of the first procedure and the starting of the second procedure (only applies in serial arm)
Time elapsed in minutes between the end of the first procedure and the starting of the second procedure (only applies in serial arm)
Upper GI inspection time
Time frame: Time taken in minutes to inspect the entire upper GI mucosa according to the complete photodocumentation method proposed by Emura et al.
Time taken in minutes to inspect the entire upper GI mucosa according to the complete photodocumentation method proposed by Emura et al.
Colonoscopy withdrawal time
Time frame: Time elapsed in minutes between the cecum and the lower rectum used to inspect the colorectal mucosa
Time elapsed in minutes between the cecum and the lower rectum used to inspect the colorectal mucosa
Colonoscopy insertion time
Time frame: Time elapsed in minutes to reach the cecum
Time elapsed in minutes to reach the cecum
EGD time
Time frame: Time elapsed in minutes between the insertion of the gastroscope into the mouth and the extraction from the mouth
Time elapsed in minutes between the insertion of the gastroscope into the mouth and the extraction from the mouth
Colonoscopy time
Time frame: Time elapsed in minutes between the insertion of the colonoscope into the lower rectum and the extraction from the lower rectum
Time elapsed in minutes between the insertion of the colonoscope into the lower rectum and the extraction from the lower rectum
Propofol used in EGD
Time frame: Amount in mg of Propofol used during EGD
Amount in mg of Propofol used during EGD
Propofol used in colonoscopy
Time frame: Amount in mg of Propofol used during colonoscopy
Amount in mg of Propofol used during colonoscopy
Propofol used in EGD and colonoscopy
Time frame: Amount of Propofol in mg used fro procedures in the simultaneous arm
Amount of Propofol in mg used fro procedures in the simultaneous arm.
percutaneous pCO2
Time frame: Measurement of pCO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.
Measurement of pCO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.
percutaneous pO2
Time frame: Measurement of pO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.
Measurement of pO2 by the percutaneous transducer at 5 minutes prior and 5, 10 during procedures and 5 and 10 minutes minutes after completing the last procedure.
Position change 1
Time frame: During colonoscopy
Change of patient's position during colonoscopy. Yes or No answer
Position change 2
Time frame: During olonoscopy
If occurred, how many times the position changed. Numerical variable.
Post procedure symptoms survey related to colonoscopy
Time frame: 20 minutes after the last procedure and after 24 hours
Nausea, drowsiness, and dizziness are scored by patients using a scale from 1 to 5 (1: None, 2: Mild, 3: Moderate, 4: Severe, and 5: Extreme).
Post procedure symptoms survey related to sedation
Time frame: 20 minutes after the last procedure and after 24 hours
Abdominal pain, bloating, and pharyngeal pain are scored by patients using a scale from 1 to 5 (1: None, 2: Mild, 3: Moderate, 4: Severe, and 5: Extreme).
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 8 Dec 2020.
- Background: PubMed 31529547Emura F, Sharma P, Arantes V, Cerisoli C, Parra-Blanco A, Sumiyama K, Araya R, Sobrino S, Chiu P, Matsuda K, Gonzalez R, Fujishiro M, Tajiri H. Principles and practice to facilitate complete photodocumentation of the upper gastrointestinal tract: World Endoscopy Organization position statement. Dig Endosc. 2020 Jan;32(2):168-179. doi: 10.1111/den.13530. Epub 2019 Nov 6.
- Background: PubMed 32534934Parasa S, Reddy N, Faigel DO, Repici A, Emura F, Sharma P. Global Impact of the COVID-19 Pandemic on Endoscopy: An International Survey of 252 Centers From 55 Countries. Gastroenterology. 2020 Oct;159(4):1579-1581.e5. doi: 10.1053/j.gastro.2020.06.009. Epub 2020 Jun 11. No abstract available.
- Background: PubMed 32569438Guda NM, Emura F, Reddy DN, Rey JF, Seo DW, Gyokeres T, Tajiri H, Faigel D. Recommendations for the Operation of Endoscopy Centers in the setting of the COVID-19 pandemic - World Endoscopy Organization guidance document. Dig Endosc. 2020 Sep;32(6):844-850. doi: 10.1111/den.13777. Epub 2020 Aug 12.
- Background: PubMed 27548885Bisschops R, Areia M, Coron E, Dobru D, Kaskas B, Kuvaev R, Pech O, Ragunath K, Weusten B, Familiari P, Domagk D, Valori R, Kaminski MF, Spada C, Bretthauer M, Bennett C, Senore C, Dinis-Ribeiro M, Rutter MD. Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2016 Sep;48(9):843-64. doi: 10.1055/s-0042-113128. Epub 2016 Aug 22. No abstract available.
- Background: PubMed 21607827Trencheva K, Dhar P, Sonoda T, Lee S, Samuels J, Stein B, Milsom J. Physiologic effects of simultaneous carbon dioxide insufflation by laparoscopy and colonoscopy: prospective evaluation. Surg Endosc. 2011 Oct;25(10):3279-85. doi: 10.1007/s00464-011-1705-2. Epub 2011 May 24.
- Individual participant dataSharing planned: Yes. There is s plan to share IPD with other researchers
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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.
FABIAN EMURA, PhD principal investigator
EmuraCenter LatinoAmerica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultaneous EGD and colonoscopy in people with Procedure Time, run by EmuraCenter LatinoAmerica at 1 site in Colombia.
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 1 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 8 Dec 2020. 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 Colombia. 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?
Procedures time (time frame: Time elapsed in minutes between the starting of the first procedure and the ending time of the second procedure in the serial arm or both procedures in the simultaneous arm.). The study lists 16 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 NCT04473456, which also lists 5 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 8 Dec 2020.