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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Dr. Dan Carter, Gastroenterologist, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01496560
First received: December 19, 2011
Last updated: November 16, 2015
Last verified: November 2015

December 19, 2011
November 16, 2015
November 2015
November 2015   (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.
 
Withdrawn
0
November 2015
November 2015   (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 information is only displayed when the study is recruiting subjects
Israel
 
NCT01496560
Sheba-11-8679-DC-CTIL
No
Not Provided
Not Provided
Dr. Dan Carter, Gastroenterologist, Sheba Medical Center
Sheba Medical Center
Not Provided
Principal Investigator: Dan Carter, MD Sheba Medical Center
Sheba Medical Center
November 2015

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