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

Withdrawn

• Conditions: Pain

• Registration Number: NCT01496560
• Lead Sponsor: Sheba Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-12-19
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-21
• Status Verified: 2015-11
• Study Start: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pre-endoscopic Rectal balloon volumes	1 year	Volume for first sensation, desire to deficate and maximal tolerance volume

Secondary Outcome Measures

Name	Time	Method
Demographic data	1 year	Demographic data related to excessive pain
Pre-endocopic levels of anxiety	1 year	Relation of Pre-endoscopic levels of anxiety to pain during colonoscopy

Trial Locations

Locations (1)

Sheba medical center; 🇮🇱 Ramat GAn, Israel