Clinical trial NCT03016026: Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Gastrectomy
Official title: Effect of Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Subtotal Gastrectomy: A Single Arm Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stomach Neoplasms
Keywords: ERAS,Laparoscopy,Distal Gastrectomy,Safety,Effectiveness
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative hospital stays
timeFrame: 1 month
measure: Rehabilitative rate
timeFrame: 4 days
Secondary outcomes:
measure: Medical cost
timeFrame: 1 month
measure: Postoperative pain score
timeFrame: 4 days
measure: Postoperative recovery index
timeFrame: 1 month
measure: Postoperative inflammatory immune response
timeFrame: 4 days
measure: Morbidity rates
timeFrame: 30 days
measure: Mortality rates
timeFrame: 30 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Southern Medical University, Guangzhou,China
name: Guoxin Li, MD.,Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern Medical University, Guangzhou,China
name: Kexuan Liu, MD.,Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern Medical University, Guangzhou,China
name: Hao Liu, MD.,Ph.D
role: STUDY_DIRECTOR
affiliation: Southern Medical University, Guangzhou,China
name: Li Zhen, MD.,Ph.D
role: STUDY_DIRECTOR
affiliation: Southern Medical University, Guangzhou,China
name: Xiaomin Hou, MD.,Ph.D
role: STUDY_DIRECTOR
affiliation: Southern Medical University, Guangzhou,China
name: Jiang Yu, MD.,Ph.D
role: STUDY_DIRECTOR
affiliation: MD.,Ph.D
name: Yu Zhu, MD.
role: STUDY_DIRECTOR
References:
citation: Liang Y, Liu H, Nurse LZ, Zhu Y, Zhao M, Hu Y, Yu J, Li C, Liu K, Li G. Enhanced recovery after surgery for laparoscopic gastrectomy in gastric cancer: A prospective study. Medicine (Baltimore). 2021 Feb 19;100(7):e24267. doi: 10.1097/MD.0000000000024267.