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

Sponsor
Inje University (Other)
Overall Status
Completed
CT.gov ID
NCT01284764
Collaborator
(none)
144
Enrollment
1
Location
2
Arms
8
Duration (Months)
18
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Diagnostic
Official Title:
Efficacy of a Low Volume of Water Intake and Mosapride for Endoscopy Preparation in Gastric Cancer Patients With Subtotal Gastrectomy: A Randomized Controlled Trial
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Sep 1, 2011

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Degrees of food residue using endoscopic scoring system [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.

    Secondary Outcome Measures

    1. Tolerability of a low volume of water and mosapride [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Haeundae Paik Hospital, Inje University School of Medicine Busan Korea, Republic of 612-030

    Sponsors and Collaborators

    • Inje University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eun Hee Seo, fellow, Inje University
    ClinicalTrials.gov Identifier:
    NCT01284764
    Other Study ID Numbers:
    • HGI-2011-01
    First Posted:
    Jan 27, 2011
    Last Update Posted:
    Oct 5, 2011
    Last Verified:
    Oct 1, 2011
    Keywords provided by Eun Hee Seo, fellow, Inje University
    Endoscopy
    Gastrectomy
    Stomach neoplasms
    Additional relevant MeSH terms:
    Foreign Bodies
    Mosapride

    Study Results

    No Results Posted as of Oct 5, 2011