ERAS (Early Recovery After Surgery) Protocol After Laparoscopic Total Gastrectomy and Proximal Gastrectomy

Not Applicable

• Conditions: Gastric Cancer
• Interventions: Procedure: ERAS perioperative cares; Procedure: Conventional perioperative cares

• Registration Number: NCT03079596
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of reducing the surgical stress response and obtaining optimal recovery after surgery.

Detailed Description

There is strong evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of conventional treatment.

However, few studies exist about the implication of ERAS programs in the laparoscopic gastrectomy.

The aim of this study was to compare the recovery rate, morbidity, and quality of life in the patients undergoing laparoscopic total gastrectomy and proximal gastrectomy for gastric cancer, receiving either ERAS protocol or conventional postoperative cares.

Study Timeline

• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-14
• Study Start: 2019-10-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-09
• Last Update Posted: 2021-08-11
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Elective surgery
• American Society of Anesthesiologists (ASA) scores < 3
• Gastric cancer, adenocarcinoma, possible to perform laparoscopic total gastrectomy and proximal gastrectomy
• Informed consent
• No other treatment (Radiation, Chemotherapy or Immunotherapy) on this gastric cancer or other type of cancer.
• No systemic inflammatory disease

Exclusion Criteria

• conversion to open

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ERAS perioperative cares	ERAS perioperative cares	Patients planned to undergoing laparoscopic total gastrectomy, following the ERAS protocols
Conventional perioperative cares	Conventional perioperative cares	Patents will be managed by our hospital's critical pathways

Primary Outcome Measures

Name	Time	Method
Tolerance of diet for 24 hours	4 days after surgery	Tolerance of diet for 24 hours. Able to eat one third of more of soft-blend meal without abdominal discomfort, bloating, nausea, or vomiting
Analgesic-free	4 days after surgery	Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA)
Safe ambulation	4 days after surgery	Safe ambulation (ambulation of 600m without assistance)
Afebrile status without major complications	4 days after surgery	Afebrile status without major complications (fever defined as body temperature greater than 37.5)

Secondary Outcome Measures

Name	Time	Method
Postoperative length of hospital stay	up to 4 weeks after surgery	Postoperative length of hospital stay
Time to tolerance of a full diet	up to 1 month after surgery	Time to tolerance of a full diet
Time to first bowel motion	up to 7 days after surgery	Time to first bowel motion

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of