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NCT Number: NCT06209983

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Anesthesiology General Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ERAS

Procedure
  • 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

Procedure
  • 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.

Primary outcomes

  1. Length of hospital stay

    Time frame: From date of admission until the date of discharge, assessed up to 2 weeks.

    When patient discharge.

Secondary outcomes

  1. Complication rates

    Time frame: 28 days

    The complication rates means if there are any complications occur.

Other outcomes

  1. Readmission rates

    Time frame: within 28 days

    when the patient is readmitted to the hospital

  2. costs of hospitalization

    Time frame: From date of admission until the date of discharge, assessed up to 2 weeks.

    Total medical expenses incurred during the admission period.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Jan 18, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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