The Optimal Sequence in Same-day Bidirectional Endoscopy Under Deep Anesthesia.

Not Applicable

• Conditions: Deep Sedation; Bidirectional Endoscopy
• Interventions: Procedure: EGD first; Procedure: Colonoscopy first

• Registration Number: NCT04973878
• Lead Sponsor: Ruijin Hospital

Brief Summary

The purpose of this study is to explore the optimal sequence of same-day bidirectional endoscopy under deep anesthesia induced by propofol combined with fentanyl.

Detailed Description

Same-day bidirectional endoscopy are commonly performed to evaluate iron deficiency anemia, positive fecal occult blood, abdominal pain and cancer screening. In order to reducing intraoperative pain, providing better operating conditions and improving the endoscopic examination quality, endoscopy with anesthesia assistance has gradually become the choice of more patients. However, the optimal sequence of procedures for same-day bidirectional endoscopy has not been established. This is a two-center, single-blind, randomized, controlled trial. Patients undergoing same-day bidirectional endoscopy under deep sedation will be randomly assigned to either the colonoscopy-first group (colonoscopy followed by EGD, n = 272) or the EGD(esophagogastroduodenoscopy)-first group (EGD followed by colonoscopy, n = 272).The detection rate of adenoma（ADR）, the ADR of right-side colon , Boston score of right-side colon, total dose of anesthetics, operation time, recovery time, adverse events and patient satisfaction will be evaluated.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-17
• Study First Submitted QC: 2021-07-17
• Last Update Submitted: 2021-07-17
• Study First Posted: 2021-07-22
• Last Update Posted: 2021-07-22
• Study Start: 2021-07-30
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 544

Inclusion Criteria

• Any patient with a clinical indication for receiving same day bi-directional endoscopies.

Exclusion Criteria

• Contraindications of colonoscopy: acute peritonitis; intestinal perforation or suspected intestinal perforation; acute anorectal infection or painful lesions; menstruation; pregnancy; cardiopulmonary insufficiency; prior abdominal and pelvic surgery.
• Contraindications for EGD: severe heart disease, severe heart failure; severe lung disease: asthma : severe hypertension; acute perforation of esophagus, stomach and duodenum; acute severe pharynx and larynx disease gastroscopy can not be inserted; acute stage of corrosive esophageal injury; prior upper digestive tract operation.
• Contraindications for oral intestinal laxative: severe gastrointestinal obstruction or stricture; toxic megacolon; severe acute intestinal infection; dysphagia; disturbance of consciousness; allergy to drug ingredients.
• Allergic to emulsions or opioids.
• ASA score ≥ III

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	EGD first	EGD performed before the Colonoscopy
Group B	Colonoscopy first	Colonoscopy performed before the EGD

Primary Outcome Measures

Name	Time	Method
Adenoma Detection Rate	1 year	Adenoma detection rate is the proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas detected. In this study, ADR during the colonoscopy will recorded.
Adenoma Detection Rate of the right-sided colon	1 year	The ADR of right-sided colon will be recorded.Right -sided colon is refered to cecum, ascending colon and ileocecal junction.
The boston bowel preparation scale of the right-sided colon	1 year	During colonoscopy, the boston bowel preparation scale of the right-sided colon will be recorded and compared between the two study groups.

Secondary Outcome Measures

Name	Time	Method
Recovery time	1 year	Time between the end of the procedure and patient waken-up will be recorded.
Adverse events	1 year	Intraprocedure adverse events will be documented (oxygen saturation \<90% for \>30 s, systolic blood pressure drop for 30 %, and heart rate \<50 or \>120 beats/min lasting \>30 s).
Overall patient satisfaction	1 year	Patient satisfaction will be assessed after the procedures using 10-cm visual analog scale.
Sedation use	1 year	During bidirectional endoscopy, the total doses of propofol and fentanyl will be recorded.
Overall Duration of BDE Examinations	1 year	The overall duration of both EGD and colonoscopy examinations will be recorded.