Single Center Open Prospective Study for the Comparison of Procedural Sequence in Same Day Consecutive Bidirectional Endoscopy

• Conditions: Bidirectional Endoscopy

• Registration Number: NCT01491126
• Lead Sponsor: Sheba Medical Center

Brief Summary

The investigators study aim is to determine whether there is a any advantage in starting with upper or lower endoscopy. The main study objective will be the amount of analgesia needed for sustaining the examinee's comfort during the exams. Secondary endpoints will rate of detection of significant pathologies, total time of procedure, examinee's tolerance, time to recovery and examinee's satisfaction.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-11
• Study First Submitted QC: 2011-12-12
• Study First Posted: 2011-12-13
• Study Start: 2012-01
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-02-25
• Primary Completion: 2014-12
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• Age> 18
• Same day bidirectional endoscopy

Exclusion Criteria

• Prior failed endoscopy.
• Any major complication during previous endoscopy.
• Difficulty in communication with the patients.
• Psychiatric disease or mental retardation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose of mephridine and midazolam	1 year	Dose of analgestices used in order to achive concious sedation

Secondary Outcome Measures

Name	Time	Method
Time to recovery	1 year	Time to full recovery and release after endoscopies
Rate of significant findings	1 year	Rate of significant findings: colonoscopy: polyps, carcinoma, inflammation, diverticuli, A-V malformations Upper endoscopy: Barret's esophagus, severe esophagitis, gastritis, peptic ulcer disease, polyps and space occupying lesions

Trial Locations

Locations (1)

Sheba medical center; 🇮🇱 Ramat Gan, Israel