The Optimal Sequence in Same-day Bidirectional Endoscopy Under Deep Anesthesia Induced by Propofol Combined With Fentanyl: A Prospective Randomized Controlled ,Two Centers Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 544
- 主要终点
- The boston bowel preparation scale of the right-sided colon
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient with a clinical indication for receiving same day bi-directional endoscopies.
排除标准
- •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
研究组 & 干预措施
Group A
EGD performed before the Colonoscopy
干预措施: EGD first (Procedure)
Group B
Colonoscopy performed before the EGD
干预措施: Colonoscopy first (Procedure)
结局指标
主要结局
The boston bowel preparation scale of the right-sided colon
时间窗: 1 year
During colonoscopy, the boston bowel preparation scale of the right-sided colon will be recorded and compared between the two study groups.
Adenoma Detection Rate
时间窗: 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
时间窗: 1 year
The ADR of right-sided colon will be recorded.Right -sided colon is refered to cecum, ascending colon and ileocecal junction.
次要结局
- Recovery time(1 year)
- Adverse events(1 year)
- Overall patient satisfaction(1 year)
- Sedation use(1 year)
- Overall Duration of BDE Examinations(1 year)
研究者
duowu zou
prof. and director
Ruijin Hospital