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

This study is not yet open for participant recruitment.
Verified May 2013 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Dr. Dan Carter, Gastroenterologist, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01496560
First received: December 19, 2011
Last updated: May 10, 2013
Last verified: May 2013
  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 Sheba Medical Center:

Primary Outcome Measures:
  • Pre-endoscopic Rectal balloon volumes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Volume for first sensation, desire to deficate and maximal tolerance volume


Secondary Outcome Measures:
  • Demographic data [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Demographic data related to excessive pain

  • Pre-endocopic levels of anxiety [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Relation of Pre-endoscopic levels of anxiety to pain during colonoscopy


Estimated Enrollment: 150
Study Start Date: June 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01496560

Contacts
Contact: Dan Carter, MD 972-3-5302197 dan.carter@sheba.health.org.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, 52621
Contact: Dan Carter, md    972-3-5302197    dan.carter@sheba.health.gov.il   
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
Study First Received: December 19, 2011
Last Updated: May 10, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Sheba Medical Center:
colonoscopy
pain
rectal balloon

ClinicalTrials.gov processed this record on April 17, 2014