NCT00273130

Brief Summary

Sixty patients scheduled for upper diagnostic gastroscopy were randomised after written informed consent into three groups.

  1. 1.transnasal gastroscopy with thin endoscope
  2. 2.transoral with thin endoscope
  3. 3.standard size trans-oral endoscopy Stress response parameters (epinephrine, nor-epinephrine and cortisol, heartrate variability data and pulse oximetry data were monitored.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 1999

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
Last Updated

September 13, 2006

Status Verified

December 1, 2003

First QC Date

January 5, 2006

Last Update Submit

September 11, 2006

Conditions

Upper Gastrointestinal Disease,Ulcers

Keywords

transnasal gastroscopy, stress response, ischaemia

Outcome Measures

Primary Outcomes (1)

  • tachycardia, ischaemia, level of stress response

Secondary Outcomes (1)

  • acceptability of transnasal endoscopy

Interventions

transnasal endoscopyPROCEDURE
transoral thin endoscopyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnostic gastroscopy, age over 18, danish speaking,

You may not qualify if:

  • use of beta blocking or any other heart rate modulating drug, antithyroid drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital, Dept of Surgery

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Gastrointestinal DiseasesUlcerFractures, StressIschemia

Condition Hierarchy (Ancestors)

Digestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsFractures, BoneWounds and Injuries

Study Officials

  • Merete Christensen, MD

    Dept of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2006

First Posted

January 9, 2006

Study Start

March 1, 1999

Study Completion

August 1, 2002

Last Updated

September 13, 2006

Record last verified: 2003-12

Locations

DK(1)