Safety and patient satisfaction of early diet after endoscopic submucosal dissection for gastric neoplasm : a prospective, randomized study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000790

Enrollment

130

Registered

2013-07-12

Start date

2011-02-28

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(time to start oral intake after the procedure of endoscopic mucosal dissection) : The early diet group starts oral intake on day 0, procedure day. The control group starts oral intake 2 days af

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The inclusion criteria were 20 years of age or over and objective diagnosis of gastric neoplasms, including early gastric cancer and gastric adenoma (low grade dysplasia, high grade dysplasia) with evidence of histology and treatment by ESD for the lesions.

Exclusion criteria

Exclusion criteria: Exclusion criteria were high risk of bleeding, including use of an antiplatelet agent such as aspirin, clopidogrel and glycoprotein IIb/IIIa antagonist, anticoagulation with warfarin and low molecular weight heparin etc., history of gastric surgery and inability or unwillingness to consent to the study.

Design outcomes

Primary

Measure	Time frame
the rate of post-ESD bleeding	—

Secondary

Measure	Time frame
patient's satisfaction;abdominal pain scale;the healing rate of post-ESD artificial ulcer;medical expenses required for the ESD procedure and hospitalization;Hospitalization period for ESD procedure	—

Countries

Korea, Republic of

Contacts

Public ContactSunyong Kim

Yonsei University Health System, Severance Hospital

Outcome results