Optimal Procedural Sequence in Same-day Bidirectional Endoscopy: A Prospective Randomized Controlled Study

Not Applicable

Completed

• Conditions: Moderate Sedation; Endoscopy
• Interventions: Procedure: EGD and colonoscopy

• Registration Number: NCT02708212
• Lead Sponsor: Evergreen General Hospital, Taiwan

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-06
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-15
• Study Start: 2016-04
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Results First Submitted: 2016-08-05
• Results First Submitted QC: 2016-10-09
• Status Verified: 2016-12
• Results First Posted: 2016-12-02
• Last Update Submitted: 2016-12-04
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Colonoscopy-EGD group	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.
EGD-colonoscopy group	EGD and colonoscopy	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.

Primary Outcome Measures

Name	Time	Method
Sedative Doses of Midazolam	On the day of bidirectional endoscopy procedures	During bidirectional endoscopy, the total doses of midazolam were recorded and compared between the two study groups.
Sedative Doses of Fentanyl	On the day of endoscopic procedures.	During bidirectional endoscopy, the total doses of fentanyl were recorded and compared between the two study groups.

Secondary Outcome Measures

Name	Time	Method
Overall Duration of BDE Examinations	On the day of bidirectional endoscopy	The overall duration of both EGD and colonoscopy examinations was recorded and compared.