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

History of Changes

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:

MedlinePlus related topics: Anxiety Colonoscopy Endoscopy

U.S. FDA Resources

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:

Park DI, Kim HJ, Park JH, Cho YK, Sohn CI, Jeon WK, Kim BI, Ryu SH, Sung IK. Factors affecting abdominal pain during colonoscopy. Eur J Gastroenterol Hepatol. 2007 Aug;19(8):695-9.

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 May 19, 2013

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