Efficacy Study of a Low Volume of Water Intake and Mosapride for Endoscopy in Patients With Subtotal Gastrectomy (SMW)

October 4, 2011 updated by: Eun Hee Seo, Inje University

Efficacy of a Low Volume of Water Intake and Mosapride for Endoscopy Preparation in Gastric Cancer Patients With Subtotal Gastrectomy: A Randomized Controlled Trial

A low volume of water intake and mosapride will effectively reduce food residue in remnant stomach for patients who had undergone subtotal gastrectomy due to gastric cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We evaluate that a 500mL of water intake and mosapride will effectively reduce food residue in remnant stomach for patients who had undergone subtotal gastrectomy due to gastric cancer. We plan to compare this method with routine midnight fasting method for endoscopy in patients with subtotal gastrectomy.

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Phase 3

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

  • Korea, Republic of
      • Busan, Korea, Republic of, 612-030
        • Haeundae Paik Hospital, Inje University School of Medicine

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Outpatients who had subtotal gastrectomy for gastric cancer

Exclusion Criteria:

  • Pregnancy
  • Lactation
  • History of anastomotic stricture
  • Recurrent advanced gastric cancer
  • Poor general condition( > 2 ECOG)
  • Other disseminated malignancy
  • Significant renal failure or congestive heart failure (CHF)
  • Liver failure

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: midnight fasting
The patients in this group will have midnight fasting the day before endoscopic examination
ACTIVE_COMPARATOR: Mosapride, low volume of water
The patients in this group will take mosapride and a 500mL water at evening of the day before endoscopic examination.
Drug: Mosapride
Mosapride 10mg, one dosage, once evening of the day before the endoscopy
Other Names:
  • Gasmotin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degrees of food residue using endoscopic scoring system
Time Frame: six months
We plan to evaluate how much a low volume of water and mosapride, compared with routine fasting, reduse food residue in gastric remnant for endoscopy.
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerability of a low volume of water and mosapride
Time Frame: six months
We plan to evaluate tolerability of a low volume of water and mosapride compared with routine fasting for endoscopy preparation in patients with subtotal gastrectomy
six months

Collaborators and Investigators

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

Sponsor

Inje University

Investigators

  • Principal Investigator: Eun Hee Seo, M.D., Haeundae Paik Hospital
  • Study Director: Tae Oh Kim, Ph.D., Haeundae Paik Hospital

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

January 1, 2011

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

January 26, 2011

First Submitted That Met QC Criteria

January 26, 2011

First Posted (ESTIMATE)

January 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 5, 2011

Last Update Submitted That Met QC Criteria

October 4, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGI-2011-01

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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