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Open Prospective Study for Determination of Predictive Measures for Pain During Colonoscopy

This study has been withdrawn prior to enrollment.
(study terminated due toTechnical issue pre -recruiting)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01496560
First Posted: December 21, 2011
Last Update Posted: November 17, 2015
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 aim of the study is to determine what precolonoscopic measures can be correlated to pain during colonoscopy

Condition
Pain

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Comparison of Procedural Sequence in Same Day Consecutive Bidirectional Endoscopy Using Moderate Sedation: A Prospective Randomized Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pre-endoscopic Rectal balloon volumes [ Time Frame: 1 year ]
    Volume for first sensation, desire to deficate and maximal tolerance volume


Secondary Outcome Measures:
  • Demographic data [ Time Frame: 1 year ]
    Demographic data related to excessive pain

  • Pre-endocopic levels of anxiety [ Time Frame: 1 year ]
    Relation of Pre-endoscopic levels of anxiety to pain during colonoscopy


Enrollment: 0
Study Start Date: November 2015
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Detailed Description:

The aim of the work is to determine prdictive pre-endoscopic factors for pain during colonoscpy. These factors may be demographic, antrophometric, socio-ecomomic, related to previous medical staus or to anxiety levels.

We will try to find an objective parameter for prdiction of pain during colonoscopy, so pre-procedural intervantion will be applied in order to reduce the pain.

  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 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing screening colonoscopy
Criteria

Inclusion Criteria:

  • age 18-70
  • screening colonoscopy

Exclusion Criteria:

  • Failed prior colonoscopy
  • pain as a main referral indication
  • complications during previous exam
  • Inpatients
  • Excision of more than 3 polyps
  • Diagnosis ofCancer, IBD
  • Incomplete exam
  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): NCT01496560


Locations
Israel
Sheba medical center
Ramat GAn, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Dan Carter, MD Sheba Medical Center
  More Information

Publications:
Responsible Party: Dr. Dan Carter, Gastroenterologist, Gastroenterologist, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01496560     History of Changes
Other Study ID Numbers: Sheba-11-8679-DC-CTIL
First Submitted: December 19, 2011
First Posted: December 21, 2011
Last Update Posted: November 17, 2015
Last Verified: November 2015

Keywords provided by Dr. Dan Carter, Gastroenterologist, Sheba Medical Center:
colonoscopy
pain
rectal balloon