NCT03079596

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for not_applicable gastric-cancer

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 14, 2017

Completed
2.6 years until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 11, 2021

Status Verified

August 1, 2021

Enrollment Period

3 years

First QC Date

March 9, 2017

Last Update Submit

August 9, 2021

Conditions

Gastric Cancer

Keywords

gastric cancerERAS (early recovery after surgery)laparoscopic total gastrectomy

Outcome Measures

Primary Outcomes (4)

  • 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

  • Analgesic-free

    Analgesic-free (oral or IV analgesic drugs not necessary after cessation of PCA)

    4 days after surgery

  • Safe ambulation

    Safe ambulation (ambulation of 600m without assistance)

    4 days after surgery

  • Afebrile status without major complications

    Afebrile status without major complications (fever defined as body temperature greater than 37.5)

    4 days after surgery

Secondary Outcomes (3)

  • Postoperative length of hospital stay

    up to 4 weeks after surgery

  • Time to tolerance of a full diet

    up to 1 month after surgery

  • Time to first bowel motion

    up to 7 days after surgery

Study Arms (2)

ERAS perioperative cares

ACTIVE COMPARATOR

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

Procedure: ERAS perioperative cares

Conventional perioperative cares

ACTIVE COMPARATOR

Patents will be managed by our hospital's critical pathways

Procedure: Conventional perioperative cares

Interventions

ERAS perioperative caresPROCEDURE

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.

ERAS perioperative cares
Conventional perioperative caresPROCEDURE

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

Conventional perioperative cares

Eligibility Criteria

Age20 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • conversion to open

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesor

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 14, 2017

Study Start

October 1, 2019

Primary Completion

October 1, 2022

Study Completion

December 31, 2022

Last Updated

August 11, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)