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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGD and colonoscopy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sedative Doses of Fentanyl | During bidirectional endoscopy, the total doses of fentanyl were recorded and compared between the two study groups. | 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. | On the day of bidirectional endoscopy procedures |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Duration of BDE Examinations | The overall duration of both EGD and colonoscopy examinations was recorded and compared. | On the day of bidirectional endoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chi-Liang Cheng, MD | Evergreen General Hospital, Taiwan | Principal Investigator |
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Eight patients were excluded from assignment due to refusal to provide informed consent (n=3), American Society of Anesthesiology class 3 (n=3), duodenal peptic stricture (n =1), and partial colectomy (n=1).
Total 129 patients were invited to participate in the study from April to July 2016, and 8 patients were excluded. Finally, 121 patients were recruited for the study which was performed in a community hospital (Evergreen General Hospital). One patient in the EGD-colonoscopy was further excluded from final analysis due to poor bowel preparation.
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| ID | Title | Description |
|---|---|---|
| FG000 | EGD-colonoscopy Group | In this study group, 60 patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients received modeate conscious sedation with fentanyl and midazolam and carbon dioxide insullfation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during endoscopy procedures. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, was recorded. Recovery time to discharge was also recorded. |
| FG001 | Colonoscopy-EGD Group | In this study group, 60 patients received a colonoscopy followed by and an EGD during a same-day bidirectional endoscopy. Patients received modeate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during EGD and colonoscopy examinations. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, were recorded. Recovery time to discharge was also recorded. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Total 120 patients were randomly assigned to EGD-colonoscopy group (n=60) and colonoscopy-EGD group (n=60).
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| ID | Title | Description |
|---|---|---|
| BG000 | EGD-colonoscopy Group | In this study group, 60 patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients received moderate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during endoscopy procedures. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, was recorded. Recovery time to discharge was also recorded. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sedative Doses of Fentanyl | During bidirectional endoscopy, the total doses of fentanyl were recorded and compared between the two study groups. | Posted | Mean | Standard Deviation | mcg/kg | On the day of endoscopic procedures. |
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From the start of bidirectional endoscopy to one hour after the completion of the bidirectional endoscopy.
The adverse events during moderate sedation were usually transient and related to overall sedative doses. The primary aim of the study was to compared the overall sedative doses between the patients receiving EGD-colonoscopy and colonoscopy-EGD sequences. Theoretically, patients who received less sedative doses should experience less episodes of adverse events. Therefore, we calculated the overall sedative doses and adverse events after the completion of both EGD and colonoscopy examinations.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EGD-colonoscopy Group | Patients received moderate conscious sedation with fentanyl and midazolam. Blood pressure, heart rate, and oxygen saturation were monitored and recorded during the endoscopic procedures. Supplemental oxygen (2 L/min) by nasal cannula was provided for every patient. The following adverse events were recorded during conscious sedation: 1) oxygen desaturation: < 90% persisting for more than 60 s; 2) hypotension: < 90 mm Hg systolic blood pressure for more than 60 s; 3) hypertension: > 180 mm Hg systolic blood pressure for more than 60 s; 4) tachycardia: > 120 beats per minute, lasting more than 60 s; and 5) bradycardia: < 50 beats per minute, lasting more than 60 s. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient hypotension | Vascular disorders | Systematic Assessment | 20 patients (33.3%) in the colonoscopy-EGD group and 19 patients (31.7%) in the EGD-colonoscopy group developed transient hypotension during the bidirectional endoscopy examinations. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chiliang Cheng | Evergreen General Hospital | +886-3-4631230 | chiliang.cheng@gmail.com |
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| ID | Term |
|---|---|
| D016145 | Endoscopy, Digestive System |
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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| BG001 | Colonoscopy-EGD Group | In this study group, 60 patients received a colonoscopy followed by and an EGD during a same-day bidirectional endoscopy. Patients received moderate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during EGD and colonoscopy examinations. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, were recorded. Recovery time to discharge was also recorded. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
In this group, patients received a colonoscopy followed by an EGD during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of fentanyl after the completion of bidirectional endoscopy were recorded. EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study. |
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| Primary | Sedative Doses of Midazolam | During bidirectional endoscopy, the total doses of midazolam were recorded and compared between the two study groups. | Posted | Mean | Standard Deviation | mg/kg | On the day of bidirectional endoscopy procedures |
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| Secondary | Overall Duration of BDE Examinations | The overall duration of both EGD and colonoscopy examinations was recorded and compared. | Posted | Mean | Standard Deviation | minutes | On the day of bidirectional endoscopy |
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| 0 |
| 60 |
| 19 |
| 60 |
| EG001 | Colonoscopy-EGD Group | Patients received moderate conscious sedation with fentanyl and midazolam. Blood pressure, heart rate, and oxygen saturation were monitored and recorded during the endoscopic procedures. Supplemental oxygen (2 L/min) by nasal cannula was provided for every patient. The following adverse events were recorded during conscious sedation: 1) oxygen desaturation: < 90% persisting for more than 60 s; 2) hypotension: < 90 mm Hg systolic blood pressure for more than 60 s; 3) hypertension: > 180 mm Hg systolic blood pressure for more than 60 s; 4) tachycardia: > 120 beats per minute, lasting more than 60 s; and 5) bradycardia: < 50 beats per minute, lasting more than 60 s. | 0 | 60 | 20 | 60 |
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| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D016099 | Endoscopy, Gastrointestinal |