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

Foreign Body Left During Endoscopic Examination Clinical Trial

— SMW  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284764
• Other study ID #: HGI-2011-01
• Status: Completed
• Phase: Phase 3
• First received: January 26, 2011
• Last updated: October 4, 2011
• Start date: January 2011
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Foreign Bodies
• Foreign Body Left During Endoscopic Examination

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Haeundae Paik Hospital, Inje University School of Medicine	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degrees of food residue using endoscopic scoring system	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	Yes
Secondary	Tolerability of a low volume of water and mosapride	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	Yes