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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Deep Sedation; Bidirectional Endoscopy

Treatments: Procedure: EGD first; Procedure: Colonoscopy first

Study type: Interventional

Funder types: Other

Identifiers

NCT04973878

RuijinH2021131

Details and patient eligibility

About

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.

Full 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.

Enrollment: 544 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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544 participants in 2 patient groups

Group A

Experimental group

Description:

EGD performed before the Colonoscopy

Treatment:

Procedure: EGD first

Group B

Experimental group

Description:

Colonoscopy performed before the EGD

Treatment:

Procedure: Colonoscopy first