Comparing Maximal and Half-maximal Suction Pressure Applied During Water Exchange in Colonoscopy

September 20, 2013 updated by: Yu-Hsi hsieh, Dalin Tzu Chi General Hospital

A Randomized, Controlled Trial Comparing Maximal and Half-maximal Suction Pressure Applied During Water Exchange in Colonoscopy

This prospective, randomize, controlled trial will compared maximal to half-maximal suction pressure applied during water exchange in patients undergoing minimally sedated colonoscopy. We test the hypothesis that maximal suction pressure is more efficient and causes shorter insertion time.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

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

  • Taiwan
      • Chia-Yi, Taiwan, 622
        • Recruiting
        • Buddhist Dalin Tzu Chi General Hospital
        • Contact:
        • Principal Investigator:
          • Yu-Hsi Hsieh, MD

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing minimally sedated colonoscopy performed by YHH

Exclusion Criteria:

  • known history of obstructive lesions of the colon,
  • allergy to meperidine,
  • massive ascites,
  • past history of partial colectomy, or
  • refusal to provide written informed consent.

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: maximal suction pressure
The pressure level of the suction unit (DF 601, Hanlien, Taipei, Taiwan) will be set at the maximal (-70 cm Hg).
Procedure: maximal pressure
The pressure level of the suction unit (DF 601, Hanlien, Taipei, Taiwan) will be set at the maximal (-70 cm Hg).
Device: Suction Unit
Other Names:
  • suction unit (DF 601, Hanlien, Taipei, Taiwan)
Active Comparator: half-maximal pressure
The pressure level of the suction unit will be set at the half-maximal (-35 cm Hg).
Device: Suction Unit
Other Names:
  • suction unit (DF 601, Hanlien, Taipei, Taiwan)
Procedure: half-maximal pressure
the pressure level of the suction unit (DF 601, Hanlien, Taipei, Taiwan) will be set at the half-maximal (-35 cm Hg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cecal intubation time
Time Frame: 30 minutes
30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
infused water amount
Time Frame: 30 minutes
30 minutes
aspirated water amount
Time Frame: 30 minutes
30 minutes
pain score
Time Frame: 30 minutes
30 minutes
suction marks on the mucosa
Time Frame: 30 minutes
30 minutes

Collaborators and Investigators

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

Sponsor

Dalin Tzu Chi General Hospital

Collaborators

Felix Leung, MD, Sepulveda Ambulatory Care Center, VAGLAHS

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

August 1, 2013

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

September 17, 2013

First Submitted That Met QC Criteria

September 20, 2013

First Posted (Estimate)

September 23, 2013

Study Record Updates

Last Update Posted (Estimate)

September 23, 2013

Last Update Submitted That Met QC Criteria

September 20, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DalinTzuChi-Hsieh-2013-2

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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