Early Recovery After Surgery (ERAS) Versus Conventional Protocol After Laparoscopic Gastrectomy

Phase 2

Completed

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

• Registration Number: NCT01938313
• 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 gastrectomy for gastric cancer, receiving either ERAS protocol or conventional postoperative cares.

Study Timeline

• Study First Submitted: 2012-07-15
• Study Start: 2012-08
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-10
• Primary Completion: 2014-08
• Study Completion: 2016-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-04
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

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

Inclusion Criteria

• Elective surgery
• American Society of Anesthesiologists (ASA) scores < 3
• 20 < Age < 80
• Gastric cancer, adenocarcinoma, possible to perform laparoscopic distal gastrectomy
• Informed consent
• No other treatment (Radiation, Chemotherapy or Immunotherapy) on this gastric cancer or other type of cancer.
• No systemic inflammatory disease

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Exclusion Criteria

• Emergency operation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Recovering Rate	4 days after surgery	1. Tolerance of diet for 24 hours A. Able to eat one third of more of soft-blend meal without abdominal discomfort, bloating, nausea, or vomiting; 2. Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA); 3. Safe ambulation (ambulation of 600m without assistance); 4. Afebrile status without major complications (fever defined as body temperature greater than 37.5); * Above total 4 criteria should be satisfied for the evaluation of complete recovery.

Secondary Outcome Measures

Name	Time	Method
Postoperative length of hospital stay	up to 4 weeks after surgery
Time to tolerance of a full diet	up to 1 month after surgery
Complications during the admissionTime to first bowel motion	up to 30 days after surgery
Quality of life	up to 1 month after surgery	European organization for research and treatment of cancer (EORTC) and gastrointestinal quality of life index (GIQLI) questionnaire on postoperative 5 days, 1 month
Readmission rate	up to 30 days after surgery
Time to first bowel motion Time to first bowel motion	up to 7 days after surgery
Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days	up to 3 days after surgery	postoperative 2hours, 6 hours, 1 days, 2 days, 3 days

Trial Locations

Locations (1)

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