EndoscopyNCT02708212
Optimal Procedural Sequence in Same-day Bidirectional Endoscopy: A Prospective Randomized Controlled Study
A study testing EGD and colonoscopy in people with Endoscopy and Moderate Sedation, run by Evergreen General Hospital, Taiwan.
Trial summary
The Same-day bidirectional endoscopy (BDE) is commonly used in clinical practice. However, the optimal sequence of performing a same-day BDE has not been well-established.The primary aims of this study are to compare the sedative doses and patient discomfort between the study groups who received a colonoscopy followed… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Endoscopy, Moderate Sedation
- What is being tested?
- EGD and colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients, aged 20 to 75 years, who are scheduled for same-day bidirectional endoscopy examination for any indication are invited to participate in the study.
Who cannot join
- 1. previous gastrectomy or colectomy 2. inadequate bowel preparation, 3. obstructive lesions of the colon 4. severe colitis, gastrointestinal bleeding 5. allergy to fentanyl or midazolam 6. American Society of Anesthesiology (ASA) classification of physical status grade 3 or higher, 7. mental retardation 8. regular use of narcotics 9. pregnancy 10. refusal to provide a written informed consent.
About this study
Official title: Optimal Procedural Sequence in Same-day Bidirectional Endoscopy With Moderate Sedation and Carbon Dioxide Insufflation: A Prospective Randomized Controlled Study
The Same-day bidirectional endoscopy (BDE) is commonly used in clinical practice. However, the optimal sequence of performing a same-day BDE has not been well-established.The primary aims of this study are to compare the sedative doses and patient discomfort between the study groups who received a colonoscopy followed by and EGD (colonoscopy-EGD), or an EGD followed by a colonoscopy (EGD-colonoscopy) during a same-day BDE. The secondary aim is to assess colonoscopy performance, including the cecal intubation time and adenoma detection rate between the two endoscopic sequences.
- Conditions
- Endoscopy, Moderate Sedation
- Being tested
- EGD and colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGD and colonoscopyProcedure or surgery
Cold forceps biopsy, cold snare polypectomy, and/or hot snare polypectomy will be performed for stomach and/or colon polyps during EGD and colonoscopy examinations will be performed whenever indicated.
| Study group | Role | What they receive |
|---|---|---|
| EGD-colonoscopy group | Active comparator | In this group, patients receiving an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients receive moderate conscious sedation with fentanyl and midazolam for the procedures. Gastric polypectomy will be provided when gastric polyps are found during an EGD study. Colon polypectomy will be provided when colon polyps are found during a colonoscopy study. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation will be recorded every 60 seconds during the endoscopic examinations. Patients' tolerability to EGD and colonoscopy examinations will be scaled by patients and endoscopists after the completion of the examinations. Aldrete scores are recorded15 minutes and 25 minutes after entering the recovery room. The recovery time will also be recorded. Receives: Procedure: EGD and colonoscopy |
| Colonoscopy-EGD group | Active comparator | In this study group, patients receive a colonoscopy followed by an EGD during a same-day bidirectional endoscopy. Patients receive moderate conscious sedation with fentanyl and midazolam for the procedures. Colon polypectomy will be provided when colon polyps are found during a colonoscopy study. Gastric polypectomy will be provided when gastric polyps are found during an EGD study. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation will be recorded every 60 seconds during the endoscopic examinations. Patients' tolerability to colonoscopy and EGD examinations will be scaled by patients and endoscopists after the completion of the examinations. Aldrete scores are recorded15 minutes and 25 minutes after entering the recovery room. The recovery time will also be recorded. Receives: Procedure: EGD and colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedative Doses of Fentanyl
During bidirectional endoscopy, the total doses of fentanyl were recorded and compared between the two study groups.
Measured: On the day of endoscopic procedures.
Sedative Doses of Midazolam
During bidirectional endoscopy, the total doses of midazolam were recorded and compared between the two study groups.
Measured: On the day of bidirectional endoscopy procedures
Secondary outcomes (1)
Overall Duration of BDE Examinations
The overall duration of both EGD and colonoscopy examinations was recorded and compared.
Measured: On the day of bidirectional endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EndoscopyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evergreen General Hospital, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Liang Cheng, Evergreen General Hospital, Taiwan
- Investigators
- Chi-Liang Cheng, MD, Principal investigator, Evergreen General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708212
- Sponsor's protocol ID
- ZEH-2016-2
- Status last verified
- Dec 2016
- First submitted
- 6 Mar 2016
- Last updated
- 1 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Procedural Sequence in Same-day Bidirectional Endoscopy With Moderate Sedation and Carbon Dioxide Insufflation: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02708212
- Acronym / sponsor ID
- ZEH-2016-2
- Conditions
- Endoscopy, Moderate Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Evergreen General Hospital, TaiwanUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Posted 2 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Same-day bidirectional endoscopy (BDE) is commonly used in clinical practice. However, the optimal sequence of performing a same-day BDE has not been well-established.The primary aims of this study are to compare the sedative doses and patient discomfort between the study groups who received a colonoscopy followed by and EGD (colonoscopy-EGD), or an EGD followed by a colonoscopy (EGD-colonoscopy) during a same-day BDE. The secondary aim is to assess colonoscopy performance, including the cecal intubation time and adenoma detection rate between the two endoscopic sequences.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGD-colonoscopy group | Active comparator | Procedure: EGD and colonoscopyIn this group, patients receiving an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients receive moderate conscious sedation with fentanyl and midazolam for the procedures. Gastric polypectomy will be provided when gastric polyps are found during an EGD study. Colon polypectomy will be provided when colon polyps are found during a colonoscopy study. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation will be recorded every 60 seconds during the endoscopic examinations. Patients' tolerability to EGD and colonoscopy examinations will be scaled by patients and endoscopists after the completion of the examinations. Aldrete scores are recorded15 minutes and 25 minutes after entering the recovery room. The recovery time will also be recorded. |
| Colonoscopy-EGD group | Active comparator | Procedure: EGD and colonoscopyIn this study group, patients receive a colonoscopy followed by an EGD during a same-day bidirectional endoscopy. Patients receive moderate conscious sedation with fentanyl and midazolam for the procedures. Colon polypectomy will be provided when colon polyps are found during a colonoscopy study. Gastric polypectomy will be provided when gastric polyps are found during an EGD study. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation will be recorded every 60 seconds during the endoscopic examinations. Patients' tolerability to colonoscopy and EGD examinations will be scaled by patients and endoscopists after the completion of the examinations. Aldrete scores are recorded15 minutes and 25 minutes after entering the recovery room. The recovery time will also be recorded. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients, aged 20 to 75 years, who are scheduled for same-day bidirectional endoscopy examination for any indication are invited to participate in the study.
Key exclusion criteria (1 listed)
- 1. previous gastrectomy or colectomy 2. inadequate bowel preparation, 3. obstructive lesions of the colon 4. severe colitis, gastrointestinal bleeding 5. allergy to fentanyl or midazolam 6. American Society of Anesthesiology (ASA) classification of physical status grade 3 or higher, 7. mental retardation 8. regular use of narcotics 9. pregnancy 10. refusal to provide a written informed consent.
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 and colonoscopyCold forceps biopsy, cold snare polypectomy, and/or hot snare polypectomy will be performed for stomach and/or colon polyps during EGD and colonoscopy examinations will be performed whenever indicated. | Procedure or surgery | Colonoscopy-EGD group, EGD-colonoscopy group |
Primary outcome
Sedative Doses of Fentanyl
Time frame: On the day of endoscopic procedures.
During bidirectional endoscopy, the total doses of fentanyl were recorded and compared between the two study groups.
Sedative Doses of Midazolam
Time frame: On the day of bidirectional endoscopy procedures
During bidirectional endoscopy, the total doses of midazolam were recorded and compared between the two study groups.
1 secondary outcome
Overall Duration of BDE Examinations
Time frame: On the day of bidirectional endoscopy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Chi-Liang Cheng, MD principal investigator
Evergreen General Hospital, Taiwan
Questions about this trial
What is this clinical trial studying?
A study testing EGD and colonoscopy in people with Endoscopy and Moderate Sedation, run by Evergreen General Hospital, Taiwan.
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 1 Feb 2017. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sedative Doses of Fentanyl (time frame: On the day of endoscopic procedures.). 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?
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 1 Feb 2017.