The Safety and Feasibility of Postoperative Early Oral Nutrition after Total Gastrectomy for Gastric Carcinoma

The Safety and Feasibility of Postoperative Early Oral Nutrition after Total Gastrectomy for Gastric Carcinoma: Multicenter Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0004707

Enrollment

298

Registered

2020-02-05

Start date

2020-03-02

Completion date

Unknown

Last updated

2020-02-24

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

Conditions

None listed

Interventions

Others(postoperative early oral feeding) : Study group (Early oral nutrition): start liquid or soft diet from postoperative 1st day Control group (Conventional diet): start liquid or soft diet from po

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients undergoing total gastrectomy with adenocarcinoma in the upper or middle part of the stomach - Patients with a preoperative clinical stage I to III by the 7th AJCC gastric cancer staging system - 20 to 80 years of age - Patients with an ECOG performance of 0 to 1 - Patients who voluntarily decided to participate in this study with informed consent

Exclusion criteria

Exclusion criteria: - Patient undergoing emergency surgery due to complications such as bleeding and perforation - Patients who have been undergoing chemotherapy and radiotherapy within the last six months of surgery - Patient whose distant metastasis was confirmed preoperatively - Patients scheduled to combined other abdominal organ resection due to other organ diseases or direct invasion of stomach cancer (but, excluding the cholecystectomy for benign disease and prophylactic splenectomy for splenic hilar lymph node dissection) - Patients with a history of upper abdominal surgery except for laparoscopic cholecystectomy - Vulnerable subjects (patients with limited cognitive capability, pregnant women or those who plan to become pregnant)

Design outcomes

Primary

Measure	Time frame
postoperative morbidity within 30 days	—

Secondary

Measure	Time frame
anastomosis-related complications (leakage, bleeding, stricture);Length of postoperative hospital stay;readmission;postoperative functional recovery time;non-compliance of oral nutrition;Nutritional markers (albumin, transthyretin, CRP, NRI score)	—

Countries

Korea, Republic of

Contacts

Public ContactSun-Ju Hwang

Chonnam National University Hospital Hwasun Hospital

Outcome results