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

November 16, 2015 updated by: Dr. Dan Carter, Gastroenterologist, Sheba Medical Center

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

Study Overview

Status

Withdrawn

Conditions

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat GAn, Israel, 52621
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing screening colonoscopy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-endoscopic Rectal balloon volumes
Time Frame: 1 year
Volume for first sensation, desire to deficate and maximal tolerance volume
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic data
Time Frame: 1 year
Demographic data related to excessive pain
1 year
Pre-endocopic levels of anxiety
Time Frame: 1 year
Relation of Pre-endoscopic levels of anxiety to pain during colonoscopy
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Dan Carter, MD, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

December 19, 2011

First Submitted That Met QC Criteria

December 20, 2011

First Posted (Estimate)

December 21, 2011

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Sheba-11-8679-DC-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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