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Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Gastrectomy

Effect of Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Subtotal Gastrectomy: A Single Arm Trial

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03016026
Enrollment
98
Registered
2017-01-10
Start date
2016-11-30
Completion date
2018-07-31
Last updated
2017-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomach Neoplasms

Keywords

ERAS,Laparoscopy,Distal Gastrectomy,Safety,Effectiveness

Brief summary

This study evaluates the safety and effectiveness of enhanced recovery after surgery(ERAS) on laparoscopic distal gastrectomy for gastric cancer.All of participants received an ERAS program.

Detailed description

Preoperative education about ERAS program is administered in the ward after admission by a specific team. Breathing training and atomizing during the time of preoperative preparation is performed during hospitalization (5-7 days). Patients are allowed to eat a normal diet and intake of 1000 ml 10% carbohydrate drink 10 hours before surgery and oral 500ml 10% carbohydrate drink 2 hours before the induction of anesthesia. Mechanical bowel preparation is not recommended as routine procedure. The intravenous fluid therapy is restricted. Urinary catheters are routinely placed after anesthesia. In principle, drainage and nasogastric tube are not placed (except the concerns of surgical safety). Surgical site infiltration is implemented.All patients undergo laparoscopic distal gastrectomy. Urinary catheters are routinely removed within 24 hours after operation. An optimal management of acute postoperative pain is multimodal analgesia consists of surgical site infiltration, a nonsteroidal anti-inflammatory drug for postoperative three days (POD) and epidural analgesia. Adjunctive analgesia with acetaminophen is used after the resumption of oral intake until adequate pain relief. Patients were encouraged to move from POD 1. The patients are encouraged to a full fluid diet on POD 2. Adhere to the premise of eating little and often daily increase, then to semi-fluids to soft diet. A normal diet is often started on POD 4. Abdominal drains are routinely removed within 72 hours after operation.

Interventions

PROCEDUREERAS

Undergo an ERAS program

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Age from over 18 to under 75 years * Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy * cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition * Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy * no severe organ dysfunction * Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale * ASA (American Society of Anesthesiology) score class I or II * Written informed consent

Exclusion criteria

* Women during pregnancy or breast-feeding * Severe mental disorder * History of previous upper abdominal surgery (except laparoscopic cholecystectomy) * History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection * Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging * History of other malignant disease within past five years * History of previous neoadjuvant chemotherapy or radiotherapy * History of unstable angina or myocardial infarction within past six months * History of cerebrovascular accident within past six months * History of continuous systematic administration of corticosteroids within one month * Requirement of simultaneous surgery for other disease * Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer * FEV1\<50% of predicted values

Design outcomes

Primary

MeasureTime frameDescription
Postoperative hospital stays1 monthDays from surgery to discharge
Rehabilitative rate4 daysPostoperative 4 days

Secondary

MeasureTime frameDescription
Postoperative recovery index1 month
Postoperative inflammatory immune response4 daysPostoperative 4 days
Medical cost1 monthFrom surgery to discharge
Mortality rates30 days
Morbidity rates30 days
Postoperative pain score4 daysPostoperative 4 days

Countries

China

Contacts

Primary ContactGuoxin Li, MD.,Ph.D
gzliguoxin@163.com+86-138-0277-1450
Backup ContactHao Liu, MD.,Ph.D
283934099@qq.com+86-138-2215-8578

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026