ERAS (Early Recovery After Surgery) Protocol After Laparoscopic Total Gastrectomy and Proximal Gastrectomy

Gastric Cancer Clinical Trial

Official title:

Comparison of ERAS (Early Recovery After Surgery) Protocol With Conventional Protocol After Laparoscopic Total Gastrectomy and Proximal Gastrectomy: A Prospective Randomized Controlled Trial (Phase II Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03079596
• Other study ID #: B-1608-357-006
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Enhanced Recovery After Surgery (ERAS) programs have been introduced with purposes of reducing the surgical stress response and obtaining optimal recovery after surgery.

Description:

There is strong evidence of the usefulness of the ERAS programs in patients undergoing colorectal surgery in terms of significantly reduced postoperative complications and shorter length of hospital stay, compared to the patients of conventional treatment.

However, few studies exist about the implication of ERAS programs in the laparoscopic gastrectomy.

The aim of this study was to compare the recovery rate, morbidity, and quality of life in the patients undergoing laparoscopic total gastrectomy and proximal gastrectomy for gastric cancer, receiving either ERAS protocol or conventional postoperative cares.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 68 Years

Eligibility

Inclusion Criteria:

• Elective surgery

• American Society of Anesthesiologists (ASA) scores < 3

• Gastric cancer, adenocarcinoma, possible to perform laparoscopic total gastrectomy and proximal gastrectomy

• Informed consent

• No other treatment (Radiation, Chemotherapy or Immunotherapy) on this gastric cancer or other type of cancer.

• No systemic inflammatory disease

Exclusion Criteria:

• conversion to open

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• ERAS perioperative cares
Patient's preoperative counseling & education before surgery No Bowel preparation Oral Carbohydrate Solution (OCS) loading until 2hours before surgery Fluid restriction & Management by pulse contour analysis or transesophageal doppler Early mobilization Early oral feeding (postoperative 1 day - sips of water, 2 days - semifluid diet (SFD), 3 days - soft blended diet (SBD)) Epidural patient controlled analgesics (no opioids analgesics) Postoperative Nausea Active Control Thromboembolism prophylaxis by low molecular weighted heparin (LMWH) Perioperative High content Oxygen therapy No drain insertion No Levin tube Patients will be discharged at POD#4 if there's no problem.
• Conventional perioperative cares
No Patient's preoperative counseling & education before surgery Bowel preparation No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery Conventional Fluid Management by clinical signs (Urine output, heart rate etc.) Conventional Mobilization Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD) IV PCA Postoperative Nausea Control if needed No Thromboembolism prophylaxis No or Low Content Oxygen therapy Routine drain insertion Levin tube insertion if needed

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance of diet for 24 hours	Tolerance of diet for 24 hours. Able to eat one third of more of soft-blend meal without abdominal discomfort, bloating, nausea, or vomiting	4 days after surgery
Primary	Analgesic-free	Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA)	4 days after surgery
Primary	Safe ambulation	Safe ambulation (ambulation of 600m without assistance)	4 days after surgery
Primary	Afebrile status without major complications	Afebrile status without major complications (fever defined as body temperature greater than 37.5)	4 days after surgery
Secondary	Postoperative length of hospital stay	Postoperative length of hospital stay	up to 4 weeks after surgery
Secondary	Time to tolerance of a full diet	Time to tolerance of a full diet	up to 1 month after surgery
Secondary	Time to first bowel motion	Time to first bowel motion	up to 7 days after surgery