跳至主要内容
临床试验/NCT00273117
NCT00273117终止不适用

Transnasal and Conventional Oral Diagnostic Gastroscopy. A Prospective Randomised Study.

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2002年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
100
试验地点
1

研究概览

简要总结

Two groups of patients were randomised into two groups of either transnasal gastroscopy or conventional type gastroscopy (n=98). The aim of the study was to evaluate the cardiorespiratory effects and sideeffects of the two methods, and to evaluate the technical features of the transnasal endoscope.

详细描述

Introduction Esophagogastroduodenoscopy is the gold standard investigation for upper gastrointestinal disorders. To make the procedure safer and more comfortable, thinner endoscopes for conventional oral or for transnasal intubation have been designed. Several trials have been conducted suggesting greater patient tolerance with the thinner scope. At the same time scope features have improved and are increasingly compatible with the standard endoscope. This prospective, randomised study was conducted to evaluate the cardiopulmonary effects, the patient tolerance, and endoscopist evaluation comparing thin transnasal with conventional transoral endoscopy.

Patients and Methods Outpatients referred to diagnostic, upper gastrointestinal endoscopy were included consecutively after written informed consent. Inclusion criteria were age over 18 years, Danish-language, no history of disease in the nasal cavity and intended diagnostic endoscopy. Ninety-eight patients were included and randomised to either conventional oral gastroscopy (OG) or transnasal gastroscopy (TG).The patients were randomized by consecutively numbered envelopes.

The patients answered a questionnaire clarifying their previous experience of gastroscopy, and if relevant, the discomfort of previous examination and their anxiety for the actual examination on a visual analogue scale (VAS scale). A post endoscopy questionnaire evaluated discomfort during the examination in general, during introduction of the endoscope and for the rest of the examination (VAS scale). The following parameters were assessed by answering yes or no; gagging, choking, pain from the nose, throat and the stomach. The patients stated whether the degree of discomfort had been greater, lesser or as expected compared to previous endoscopy and whether they in a future gastroscopy would prefer sedation, and finally they stated their preference for a future procedure (OG/TG).

TG were carried out using Olympus Videoscope GIF-N230 (Olympus Optical Ltd., Tokyo, Japan) with an outer diameter of 6 mm and working length of 925 mm (first 15 patients); and later Olympus Videoscope GIF-XP160 (33 patients) with an outer diameter of 5.9 mm, and a working length of 1030 mm. OG were carried out using Olympus Videoscope GIF-Q160 with an outer diameter of 9.5 mm and a working length of 1030 mm.

All patients received topical anaesthesia; before TG xylocain gel were inhaled into each nostril and before OG xylocain spray (10 mg/dose), 4 doses were spayed into the pharyngeal cavity. Intravenous sedation using midazolam were used only if specifically requested by the patient. The patients were positioned in the left lateral recumbent position during the procedures. Endoscopies were performed by experienced endoscopists.

研究设计

研究类型
Observational
观察模型
Natural History
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnostic gastroscopy, written informed consent

排除标准

  • history of broken nose or disease of the nasal cavity, no Danish language, age under 18

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验

Transnasal and Oral Gastroscopy. | 临床试验