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

February 24, 2014 updated by: Dr. Dan Carter, Gastroenterologist, Sheba Medical Center
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Ramat Gan, Israel, 55261
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Study population will include sequential examinees undergoing bidirectional endoscopy. The decision to perform same day sequential bidirectional endoscopy is of the examinee's caring gastroenterologist, and not part of the study. Only examinees > 18 years will be eligible.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
examinees undergoing bidirectional endoscopy
Study population will include sequential examinees undergoing bidirectional endoscopy, age> 18 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose of mephridine and midazolam
Time Frame: 1 year
Dose of analgestices used in order to achive concious sedation
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to recovery
Time Frame: 1 year
Time to full recovery and release after endoscopies
1 year
Rate of significant findings
Time Frame: 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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Dan Carter, MD, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

December 11, 2011

First Submitted That Met QC Criteria

December 12, 2011

First Posted (Estimate)

December 13, 2011

Study Record Updates

Last Update Posted (Estimate)

February 25, 2014

Last Update Submitted That Met QC Criteria

February 24, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SHEBA-11-8951-DC-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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