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

December 19, 2011
May 10, 2013
June 2013
June 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01496560 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Open Prospective Study for Determination of Predictive Measures for Pain During Colonoscopy
Comparison of Procedural Sequence in Same Day Consecutive Bidirectional Endoscopy Using Moderate Sedation: A Prospective Randomized Study

The aim of the study is to determine what precolonoscopic measures can be correlated to pain during colonoscopy

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
1 Day
Not Provided
Non-Probability Sample

Patients undergoing screening colonoscopy

Pain
Not Provided
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
150
December 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
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
Israel
 
NCT01496560
Sheba-11-8679-DC-CTIL
No
Dr. Dan Carter, Gastroenterologist, Sheba Medical Center
Sheba Medical Center
Not Provided
Principal Investigator: Dan Carter, MD Sheba Medical Center
Sheba Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP