An interventional study of EGD and colonoscopy in Endoscopy and Moderate Sedation, sponsored by Evergreen General Hospital, Taiwan. Completed. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-02-01.
Sponsored by Evergreen General Hospital, Taiwan · Not applicable, Interventional, and Health services research
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.
Evergreen General Hospital, Taiwan is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: EGD and colonoscopy
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.
Procedure: EGD and colonoscopy
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.
Sedative Doses of Fentanyl
During bidirectional endoscopy, the total doses of fentanyl were recorded and compared between the two study groups.
Time frame: 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.
Time frame: On the day of bidirectional endoscopy procedures
Overall Duration of BDE Examinations
The overall duration of both EGD and colonoscopy examinations was recorded and compared.
Time frame: On the day of bidirectional endoscopy
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.
| Milestone | EGD-colonoscopy Group | Colonoscopy-EGD Group |
|---|---|---|
| Started | 60 | 60 |
| Completed | 60 | 60 |
| Not completed | 0 | 0 |
During bidirectional endoscopy, the total doses of fentanyl were recorded and compared between the two study groups.
| mcg/kg | EGD-colonoscopy Group | Colonoscopy-EGD Group |
|---|---|---|
| Sedative Doses of Fentanyl | 1.09 ± 0.42 | 1.28 ± 0.31 |
During bidirectional endoscopy, the total doses of midazolam were recorded and compared between the two study groups.
| mg/kg | EGD-colonoscopy Group | Colonoscopy-EGD Group |
|---|---|---|
| Sedative Doses of Midazolam | 0.08 ± 0.03 | 0.10 ± 0.02 |
The overall duration of both EGD and colonoscopy examinations was recorded and compared.
| minutes | EGD-colonoscopy Group | Colonoscopy-EGD Group |
|---|---|---|
| Overall Duration of BDE Examinations | 32.7 ± 9.9 | 33.3 ± 7.5 |
Collected over From the start of bidirectional endoscopy to one hour after the completion of the bidirectional endoscopy.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EGD-colonoscopy Group | — | 0/60 (0%) | 19/60 (31.7%) |
| Colonoscopy-EGD Group | — | 0/60 (0%) | 20/60 (33.3%) |
| Event | EGD-colonoscopy Group | Colonoscopy-EGD Group |
|---|---|---|
| Transient hypotensionVascular disorders | 19/60 | 20/60 |
Total 120 patients were randomly assigned to EGD-colonoscopy group (n=60) and colonoscopy-EGD group (n=60).
| Age, Continuous(years) | EGD-colonoscopy Group | Colonoscopy-EGD Group | Total |
|---|---|---|---|
| Mean | 54.5 ± 11.1 | 52.9 ± 12.7 | 53.7 ± 11.9 |
| Gender(Participants) | EGD-colonoscopy Group | Colonoscopy-EGD Group | Total |
|---|---|---|---|
| Female | 34 | 30 | 64 |
| Male | 26 | 30 | 56 |
| Region of Enrollment(participants) | EGD-colonoscopy Group | Colonoscopy-EGD Group | Total |
|---|---|---|---|
| Taiwan | 60 | 60 | 120 |
No study locations are listed for this record.
Plan to share: Undecided
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Evergreen General Hospital, Taiwan