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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
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, see Learn About Clinical Studies.

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 July 24, 2014