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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eun Hee Seo, Inje University
ClinicalTrials.gov Identifier:
NCT01284764
First received: January 26, 2011
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Foreign Body Left During Endoscopic Examination
Drug: Mosapride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Inje University:

Primary Outcome Measures:
  • Degrees of food residue using endoscopic scoring system [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    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:
  • Tolerability of a low volume of water and mosapride [ Time Frame: six months ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 144
Study Start Date: January 2011
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Gasmotin

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284764

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: Eun Hee Seo, fellow, Inje University
ClinicalTrials.gov Identifier: NCT01284764     History of Changes
Other Study ID Numbers: HGI-2011-01
Study First Received: January 26, 2011
Last Updated: October 4, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Inje University:
Endoscopy
Gastrectomy
Stomach neoplasms

Additional relevant MeSH terms:
Foreign Bodies
Wounds and Injuries
Mosapride
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014