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

Phase 3

Completed

• Conditions: Foreign Body Left During Endoscopic Examination
• Interventions: Drug: Mosapride

• Registration Number: NCT01284764
• Lead Sponsor: Inje University

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.

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Primary Completion: 2011-07
• Study Completion: 2011-09
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-04
• Last Update Posted: 2011-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mosapride, low volume of water	Mosapride	The patients in this group will take mosapride and a 500mL water at evening of the day before endoscopic examination.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Haeundae Paik Hospital, Inje University School of Medicine; 🇰🇷 Busan, Korea, Republic of