NCT01496560

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2011

Completed
3.9 years until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

Same day

First QC Date

December 19, 2011

Last Update Submit

November 16, 2015

Conditions

Pain

Keywords

colonoscopypainrectal balloon

Outcome Measures

Primary Outcomes (1)

  • Pre-endoscopic Rectal balloon volumes

    Volume for first sensation, desire to deficate and maximal tolerance volume

    1 year

Secondary Outcomes (2)

  • Demographic data

    1 year

  • Pre-endocopic levels of anxiety

    1 year

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing screening colonoscopy

You may qualify if:

  • age 18-70
  • screening colonoscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba medical center

Ramat Gan, 52621, Israel

Location

Related 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. doi: 10.1097/01.meg.0000219097.32811.24.

    PMID: 17625440BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dan Carter, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gastroenterologist

Study Record Dates

First Submitted

December 19, 2011

First Posted

December 21, 2011

Study Start

November 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

IL(1)