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NCT01496560 Clinical Trial

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

Pain Clinical Trial

Official title:
Comparison of Procedural Sequence in Same Day Consecutive Bidirectional Endoscopy Using Moderate Sedation: A Prospective Randomized Study

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01496560
Other study ID # Sheba-11-8679-DC-CTIL
Secondary ID
Status Withdrawn
Phase N/A
First received December 19, 2011
Last updated November 16, 2015
Start date November 2015
Est. completion date November 2015

Study information
Verified date November 2015
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Sheba medical center Ramat GAn

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pre-endoscopic Rectal balloon volumes Volume for first sensation, desire to deficate and maximal tolerance volume 1 year No
Secondary Demographic data Demographic data related to excessive pain 1 year No
Secondary Pre-endocopic levels of anxiety Relation of Pre-endoscopic levels of anxiety to pain during colonoscopy 1 year No
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