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

NCT06209983 | Active Not Recruiting

• 1 other identifier: 201809008RINC
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesiology; General Surgery

Keywords

ERAS; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  When patient discharge.

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

Secondary Outcomes (1)

• Complication rates

  28 days

Other Outcomes (2)

• Readmission rates

  within 28 days

• costs of hospitalization

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

Study Arms (2)

Arm E

EXPERIMENTAL

1. Preoperative preparation: shorten the fasting time, take a small amount of sugar water two hours before the surgery, and reduce excessive bowel preparation. 2. Intraoperative care: multi-model analgesia (mainly epidural analgesia), sleep depth monitoring, warm air blanket to avoid hypothermia. 3. 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.

Procedure: ERAS

Arm H

PLACEBO COMPARATOR

1. Preoperative preparation: overnight fasting preparation, bowel preparation. 2. 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). 3. 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.

Procedure: Conventional care

Interventions

ERAS PROCEDURE

1. Preoperative preparation: shorten the fasting time, take a small amount of sugar water two hours before the surgery, and reduce excessive bowel preparation. 2. Intraoperative care: multi-model analgesia (mainly epidural analgesia), sleep depth monitoring, warm air blanket to avoid hypothermia. 3. 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.

Arm E

Conventional care PROCEDURE

1. Preoperative preparation: overnight fasting preparation, bowel preparation. 2. 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). 3. 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.

Arm H

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: January 18, 2024
• Study Start: December 5, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 28, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)