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

NCT ID: NCT01284764

Last Updated: 2011-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Foreign Body Left During Endoscopic Examination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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midnight fasting

The patients in this group will have midnight fasting the day before endoscopic examination

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Mosapride

Intervention Type DRUG

Mosapride 10mg, one dosage, once evening of the day before the endoscopy

Interventions

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Mosapride

Mosapride 10mg, one dosage, once evening of the day before the endoscopy

Intervention Type DRUG

Other Intervention Names

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Gasmotin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role lead

Responsible Party

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Eun Hee Seo

fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eun Hee Seo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Haeundae Paik Hospital

Tae Oh Kim, Ph.D.

Role: STUDY_DIRECTOR

Haeundae Paik Hospital

Locations

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Haeundae Paik Hospital, Inje University School of Medicine

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HGI-2011-01

Identifier Type: -

Identifier Source: org_study_id