Gastric Cancer
Conditions
Keywords
gastric cancer, ERAS (early recovery after surgery), fast track, laparoscopic gastrectomy
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.
Interventions
PROCEDUREERAS perioperative cares
1. Patient's preoperative counseling & education before surgery 2. No Bowel preparation 3. Oral Carbohydrate Solution (OCS) loading until 2hours before surgery 4. Fluid restriction & Management by pulse contour analysis or transesophageal doppler 5. Early mobilization 6. Early oral feeding (postoperative 1 day - sips of water, 2 days - semifluid diet (SFD), 3 days - soft blended diet (SBD)) 7. Epidural patient controlled analgesics (no opioids analgesics) 8. Postoperative Nausea Active Control 9. Thromboembolism prophylaxis by low molecular weighted heparin (LMWH) 10. Perioperative High content Oxygen therapy 11. No drain insertion 12. No Levin tube 13. Patients will be discharged at POD#4 if there's no problem.
PROCEDUREConventional perioperative cares
1. No Patient's preoperative counseling & education before surgery 2. Bowel preparation 3. No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery 4. Conventional Fluid Management by clinical signs (Urine output, heart rate etc.) 5. Conventional Mobilization 6. Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD) 7. IV PCA 8. Postoperative Nausea Control if needed 9. No Thromboembolism prophylaxis 10. No or Low Content Oxygen therapy 11. Routine drain insertion 12. Levin tube insertion if needed
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time to tolerance of a full diet | up to 1 month after surgery | — |
| Time to first bowel motion Time to first bowel motion | up to 7 days after surgery | — |
| Complications during the admissionTime to first bowel motion | up to 30 days after surgery | — |
| Postoperative length of hospital stay | up to 4 weeks 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 |
| 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 | — |
Countries
South Korea
Outcome results
None listed