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

Endoscopy Clinical Trial

Official title:

Optimal Procedural Sequence in Same-day Bidirectional Endoscopy With Moderate Sedation and Carbon Dioxide Insufflation: A Prospective Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708212
• Other study ID #: ZEH-2016-2
• Status: Completed
• Phase: N/A
• First received: March 6, 2016
• Last updated: August 2, 2016
• Start date: April 2016
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Evergreen General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Endoscopy
• Moderate Sedation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Evergreen General Hospital, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedative doses	Doses of fentanyl and midazolam will be recorded after completion of both endoscopic examinations.	On the day of endoscopic procedures.	No
Secondary	Clonoscopy performance	The durations of cecal intubation time and colonoscopy withdrawal time are recorded. The colon adenoma detection rate will also be recorded.	within one week after colonosocpy.	No
Secondary	Sedation related adverse events	Blood pressure, heart rate, and oxygen saturation are monitored and recorded during the endoscopic procedures. Supplemental oxygen (2 L/min) by nasal cannula is provided for every patient. The following adverse events are 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.	On the day of endoscopic procedures.	Yes