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

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ERAS perioperative cares
Conventional perioperative cares
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, ERAS (early recovery after surgery), laparoscopic total gastrectomy

Eligibility Criteria

20 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ERAS perioperative cares

Conventional perioperative cares

Arm Description

Patients planned to undergoing laparoscopic total gastrectomy, following the ERAS protocols

Patents will be managed by our hospital's critical pathways

Outcomes

Primary Outcome Measures

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
Analgesic-free
Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA)
Safe ambulation
Safe ambulation (ambulation of 600m without assistance)
Afebrile status without major complications
Afebrile status without major complications (fever defined as body temperature greater than 37.5)

Secondary Outcome Measures

Postoperative length of hospital stay
Postoperative length of hospital stay
Time to tolerance of a full diet
Time to tolerance of a full diet
Time to first bowel motion
Time to first bowel motion

Full Information

First Posted
March 9, 2017
Last Updated
August 9, 2021
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03079596
Brief Title
ERAS (Early Recovery After Surgery) Protocol After Laparoscopic Total Gastrectomy and Proximal Gastrectomy
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, ERAS (early recovery after surgery), laparoscopic total gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ERAS perioperative cares
Arm Type
Active Comparator
Arm Description
Patients planned to undergoing laparoscopic total gastrectomy, following the ERAS protocols
Arm Title
Conventional perioperative cares
Arm Type
Active Comparator
Arm Description
Patents will be managed by our hospital's critical pathways
Intervention Type
Procedure
Intervention Name(s)
ERAS perioperative cares
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional perioperative cares
Intervention Description
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
Primary Outcome Measure Information:
Title
Tolerance of diet for 24 hours
Description
Tolerance of diet for 24 hours. Able to eat one third of more of soft-blend meal without abdominal discomfort, bloating, nausea, or vomiting
Time Frame
4 days after surgery
Title
Analgesic-free
Description
Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA)
Time Frame
4 days after surgery
Title
Safe ambulation
Description
Safe ambulation (ambulation of 600m without assistance)
Time Frame
4 days after surgery
Title
Afebrile status without major complications
Description
Afebrile status without major complications (fever defined as body temperature greater than 37.5)
Time Frame
4 days after surgery
Secondary Outcome Measure Information:
Title
Postoperative length of hospital stay
Description
Postoperative length of hospital stay
Time Frame
up to 4 weeks after surgery
Title
Time to tolerance of a full diet
Description
Time to tolerance of a full diet
Time Frame
up to 1 month after surgery
Title
Time to first bowel motion
Description
Time to first bowel motion
Time Frame
up to 7 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyung-Ho Kim, M.D. Ph.D.
Phone
+82-31-787-7095
Email
hhkim@snubh.org
First Name & Middle Initial & Last Name & Degree
Ju-Hee Lee, M.D.
Phone
+82-31-787-7090
Email
leejuhee79@gmail.com
First Name & Middle Initial & Last Name & Degree
Hyung-Ho Kim, M.D.Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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