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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Optimal Sequence in Same-day Bidirectional Endoscopy Under Deep Anesthesia Induced by Propofol Combined With Fentanyl: A Prospective Randomized Controlled ,Two Centers Trial

Conditions
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Bidirectional Endoscopy, Deep Sedation

Intervention / Treatment
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* Procedure: EGD first
* Procedure: Colonoscopy first


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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-first group (EGD followed by colonoscopy, n = 272).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>EGD performed before the Colonoscopy | Procedure: EGD first<br>* In this group, patients receiving an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients receive deep sedation with propofol and fentanyl.<br>|
| Experimental: Group B<br>Colonoscopy performed before the EGD | Procedure: Colonoscopy first<br>* In this group, patients receiving a colonoscopy followed by EGD during a same-day bidirectional endoscopy. Patients receive deep sedation with propofol and fentanyl.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma Detection Rate | 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. | 1 year | 
| Adenoma Detection Rate of the right-sided colon | The ADR of right-sided colon will be recorded.Right -sided colon is refered to cecum, ascending colon and ileocecal junction. | 1 year | 
| The boston bowel preparation scale of the right-sided colon | During colonoscopy, the boston bowel preparation scale of the right-sided colon will be recorded and compared between the two study groups. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation use | During bidirectional endoscopy, the total doses of propofol and fentanyl will be recorded. | 1 year | 
| Overall Duration of BDE Examinations | The overall duration of both EGD and colonoscopy examinations will be recorded. | 1 year | 
| Recovery time | Time between the end of the procedure and patient waken-up will be recorded. | 1 year | 
| Adverse events | 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). | 1 year | 
| Overall patient satisfaction | Patient satisfaction will be assessed after the procedures using 10-cm visual analog scale. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bidirectional Endoscopy, Deep Sedation