Gastric Cancer
Conditions
Keywords
gastric cancer, ERAS (early recovery after surgery), laparoscopic total 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 total gastrectomy and proximal gastrectomy for gastric cancer, receiving either ERAS protocol or conventional postoperative cares.
Interventions
PROCEDUREERAS 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.
PROCEDUREConventional 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
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 68 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Postoperative length of hospital stay | up to 4 weeks after surgery | Postoperative length of hospital stay |
Countries
South Korea
Outcome results
None listed