Transnasal and Oral Gastroscopy.

This study has been terminated.
Sponsor:
Collaborator:
Glostrup University Hospital, Copenhagen
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00273117
First received: January 5, 2006
Last updated: January 6, 2006
Last verified: January 2006
  Purpose

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.


Condition Intervention Phase
Upper Gastrointestinal Disease, Duodenal or Gastric Ulcer.
Procedure: transnasal gastroscopy
Phase 3

Study Type: Observational
Study Design: Allocation: Random Sample
Observational Model: Natural History
Time Perspective: Longitudinal
Official Title: Transnasal and Conventional Oral Diagnostic Gastroscopy. A Prospective Randomised Study.

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Estimated Enrollment: 100
Study Start Date: February 2002
Estimated Study Completion Date: August 2003
  Hide Detailed Description

Detailed Description:

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.

Arterial oxygen saturation (SpO2 ) and heart rate (HR) were measured by a pulse oximeter (Nellcor Symphony N-3000, Nellcor Puritan Bennet Inc., Pleasanton, CA) twice with an interval of one minute before the procedure; twice during the procedure (one and three minutes after intubation) and finally one and two minutes after extubation. The minimum SpO2 and maximum HR were noted as was the duration of the procedure. Biopsies were taken when indicated, and the qualities of the biopsies were assessed. Adverse effects during the endoscopies were noted; e.g. epistaxis.

After the endoscopy, the endoscopists answered a questionnaire evaluating the following parameters using a VAS score: intubation, ability to aspirate gastric contents, visualization of the esophagus, the stomach, the bulb and the second part of duodenum. The presence of chromatic aberrations (after flushing and aspiration), were also assessed. It was noted whether the length of the scope was sufficient, and also in case of TG, the presence of uni- or bi-lateral stenosis of the nasal cavity and looping in esophagus. If TG could not be carried out, the reasons were noted.

Finally, the endoscopists assessed their total subjective evaluation of the endoscopy on a one-to-six scale (one: unacceptable, six: perfect).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnostic gastroscopy, written informed consent

Exclusion Criteria:

  • history of broken nose or disease of the nasal cavity, no Danish language, age under 18
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273117

Locations
Denmark
Dept of Surgery University Hospital of Glostrup
Glostrup, Denmark, 2600
Sponsors and Collaborators
Hvidovre University Hospital
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Merete Christensen, MD Dept. of Cardiothoracic Surgery, Copenhagen University Hospital Rigshospitalet, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00273117     History of Changes
Other Study ID Numbers: MC-01-GLO, Ethics commitee nr KA00066m
Study First Received: January 5, 2006
Last Updated: January 6, 2006
Health Authority: Denmark: National Ministry of Health,Copenhagen

Keywords provided by Hvidovre University Hospital:
transnasal gastroscopy
tachycardia
hypoxemia

Additional relevant MeSH terms:
Duodenal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Ulcer
Intestinal Diseases
Peptic Ulcer
Stomach Diseases

ClinicalTrials.gov processed this record on August 21, 2014