Skip to main content
OpenTrials
Completed

NCT Number: NCT02708212

Optimal Procedural Sequence in Same-day Bidirectional Endoscopy: 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endoscopy Moderate Sedation

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Overall Duration of BDE Examinations

    Time frame: On the day of bidirectional endoscopy

    The overall duration of both EGD and colonoscopy examinations was recorded and compared.

Sponsors and collaborators

Lead sponsor

Evergreen General Hospital, Taiwan

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 15, 2016
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.