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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Dr. Dan Carter, Gastroenterologist, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01491126
First Posted: December 13, 2011
Last Update Posted: February 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Dan Carter, Gastroenterologist, Sheba Medical Center
  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:


Further study details as provided by Dr. Dan Carter, Gastroenterologist, Sheba Medical Center:

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


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

  • 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


Estimated Enrollment: 170
Study Start Date: January 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
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
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


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