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

This study is not yet open for participant recruitment.
Verified October 2012 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Dr. Dan Carter, Gastroenterologist, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01491126
First received: December 11, 2011
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition
Bidirectional Endoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Dose of mephridine and midazolam [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Dose of analgestices used in order to achive concious sedation


Secondary Outcome Measures:
  • Time to recovery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Time to full recovery and release after endoscopies

  • Rate of significant findings [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 170
Study Start Date: January 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
examinees undergoing bidirectional endoscopy
Study population will include sequential examinees undergoing bidirectional endoscopy, age> 18 years

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491126

Contacts
Contact: Dan Carter, MD 972-3-5302197 carterd@zahav.net.il
Contact: Eitan Bardan, MD 972-52-6667161 eitan.bardan@sheba.health.gov.il

Locations
Israel
Sheba medical center Not yet recruiting
Ramat Gan, Israel, 55261
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Dan Carter, MD Sheba Medical Center
  More Information

Publications:

Responsible Party: Dr. Dan Carter, Gastroenterologist, Gasteroenterologist, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01491126     History of Changes
Other Study ID Numbers: SHEBA-11-8951-DC-CTIL
Study First Received: December 11, 2011
Last Updated: October 30, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Sheba Medical Center:
Gastroscopy
Colonoscopy
Anesthesia
Recovery

ClinicalTrials.gov processed this record on May 19, 2013