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

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ClinicalTrials.gov Identifier: NCT01491126
Recruitment Status : Unknown
Verified February 2014 by Dr. Dan Carter, Gastroenterologist, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 13, 2011
Last Update Posted : February 25, 2014
Information provided by (Responsible Party):
Dr. Dan Carter, Gastroenterologist, 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.

Condition or disease
Bidirectional Endoscopy

Study Type : Observational
Estimated Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Dose of mephridine and midazolam [ Time Frame: 1 year ]
    Dose of analgestices used in order to achive concious sedation

Secondary Outcome Measures :
  1. Time to recovery [ Time Frame: 1 year ]
    Time to full recovery and release after endoscopies

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491126

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

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