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

Gastric Cancer Clinical Trial

— ERAS  

Official title:

Comparison of ERAS (Early Recovery After Surgery) Protocol With Conventional Protocol After Laparoscopic Gastrectomy: A Prospective Randomized Controlled Trial (Phase II Study))

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938313
• Other study ID #: SNUBH-ERAS-GC-PII
• Status: Completed
• Phase: Phase 2
• First received: July 15, 2012
• Last updated: January 4, 2017
• Start date: August 2012
• Est. completion date: April 2016

Study information

• Verified date: January 2017
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2016
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Exclusion Criteria:

• Emergency operation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• ERAS perioperative cares
Patient's preoperative counseling & education before surgery No Bowel preparation Oral Carbohydrate Solution (OCS) loading until 2hours before surgery Fluid restriction & Management by pulse contour analysis or transesophageal doppler Early mobilization Early oral feeding (postoperative 1 day - sips of water, 2 days - semifluid diet (SFD), 3 days - soft blended diet (SBD)) Epidural patient controlled analgesics (no opioids analgesics) Postoperative Nausea Active Control Thromboembolism prophylaxis by low molecular weighted heparin (LMWH) Perioperative High content Oxygen therapy No drain insertion No Levin tube Patients will be discharged at POD#4 if there's no problem.
• Conventional perioperative cares
No Patient's preoperative counseling & education before surgery Bowel preparation No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery Conventional Fluid Management by clinical signs (Urine output, heart rate etc.) Conventional Mobilization Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD) IV PCA Postoperative Nausea Control if needed No Thromboembolism prophylaxis No or Low Content Oxygen therapy Routine drain insertion Levin tube insertion if needed

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Geynggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovering Rate	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; Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA); Safe ambulation (ambulation of 600m without assistance); 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.	4 days after surgery	Yes
Secondary	Postoperative length of hospital stay		up to 4 weeks after surgery	Yes
Secondary	Time to tolerance of a full diet		up to 1 month after surgery	No
Secondary	Time to first bowel motion Time to first bowel motion		up to 7 days after surgery	No
Secondary	Complications during the admissionTime to first bowel motion		up to 30 days after surgery	Yes
Secondary	Readmission rate		up to 30 days after surgery	Yes
Secondary	Pain scores based on a visual analog scale the day of surgery and the subsequent 3 days	postoperative 2hours, 6 hours, 1 days, 2 days, 3 days	up to 3 days after surgery	No
Secondary	Quality of life	European organization for research and treatment of cancer (EORTC) and gastrointestinal quality of life index (GIQLI) questionnaire on postoperative 5 days, 1 month	up to 1 month after surgery	No