The Effect of Enhanced Recovery After Surgery (ERAS) in Gastric Cancer Surgery

General Surgery Clinical Trial

Official title:

The Effect of Enhanced Recovery After Surgery (ERAS) in Gastric Cancer Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06209983
• Other study ID #: 201809008RINC
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 5, 2018
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators aimed to clarify the clinical relevance of the ERAS protocol by evaluating the perioperative course in patients undergoing laparoscopic gastric cancer surgery.

Description:

Gastric cancer is 7th common malignant disease in Taiwan, accounting for 3000 new cases per year. The main treatment of gastric cancer is radical gastrectomy and lymph nodes dissection, which is associated with 13.0~46 % of surgical morbidities. To minimize the surgical morbidities and enhance patients' recovery, perioperative management is mandatory. Enhanced Recovery After Surgery (ERAS) is a multimodal, multidisciplinary approach to the care of the surgical patient. ERAS process implementation involves a team consisting of surgeons, anesthetists, an ERAS coordinator, and staff from units that care for the surgical patient. The main elements of ERAS include carbohydrate loading before surgery, minimally invasive approaches, balanced management of intravenous fluids, multimodal pain management, early mobilization, and early oral feeding, etc. Some prospective studies have shown its effectiveness in reduce surgical morbidity and hospital stay in colorectal surgery. In Taiwan, there was only limited report to study the use of ERAS in gastric cancer surgery. The investigators would like to integrate these perioperative interventions into the ERAS program, and test its effectiveness in gastric cancer patients undergoing radical gastrectomy at NTUH.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Pathological confirmed as gastric adenocarcinoma;
• Gastric cancer patients who will undergo subtotal gastrectomy.

Exclusion Criteria:

• Advanced gastric cancer with gastric outlet obstruction;
• Epidural catheter placement contraindicated or inexecutable;
• Have other cancers that have received chemotherapy or radiation therapy;
• Coagulation abnormalities;
• Pregnancy;
• Severe dysfunction of major organs (e.g., heart failure, chronic obstructive pulmonary disease, liver cirrhosis, end-stage renal disease)

Related Conditions & MeSH terms

• Anesthesiology
• General Surgery
• Stomach Neoplasms

Intervention

Procedure:
• ERAS
Preoperative preparation: shorten the fasting time, take a small amount of sugar water two hours before the surgery, and reduce excessive bowel preparation. Intraoperative care: multi-model analgesia (mainly epidural analgesia), sleep depth monitoring, warm air blanket to avoid hypothermia. Postoperative care: focus on pain relief methods (such as oral analgesics, patient-controlled epidural analgesia), early postoperative feeding (try drinking water on the first day after surgery, liquid diet on the second day, and soft diet on the third day), early removal of invasive tubes such as nasogastric tubes, intravenous catheters, and urinary catheters, and medication to prevent postoperative nausea and vomiting.
• Conventional care
Preoperative preparation: overnight fasting preparation, bowel preparation. Intraoperative care: traditional pain care (intravenous analgesics), sleep depth monitoring, warm air blanket, central venous pressure and body water monitoring indicators, traditional muscle tension relaxation treatment and the use of health insurance antagonist drugs (Neostigmine). Postoperative care: patient-controlled intravenous drip for postoperative pain relief, oral feeing (rice porridge) on the postoperative day 5, and according to the progression of patient condition, step by step to removal of invasive tubes such as nasogastric tubes, intravenous catheters, and urinary catheters.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Readmission rates	when the patient is readmitted to the hospital	within 28 days
Other	costs of hospitalization	Total medical expenses incurred during the admission period.	From date of admission until the date of discharge, assessed up to 2 weeks.
Primary	Length of hospital stay	When patient discharge.	From date of admission until the date of discharge, assessed up to 2 weeks.
Secondary	Complication rates	The complication rates means if there are any complications occur.	28 days