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Enhanced Recovery After Surgery(ERAS) for Gastric Cancer and Perioperative Nutritional Status

Sponsor
The First Hospital of Jilin University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03043183
Collaborator
(none)
1,400
Enrollment
2
Arms
55
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is a prospective, single-center, randomized controlled trial. The study protocol was approved by the Ethics Committee at the First Hospital of Jilin University.The perioperation nutritional status will be assessed in gastric cancer patients within ERAS protocols.The ERAS patients were randomly divided into perioperational nutrition support group and conventional pathway group . Inter-group differences were evaluated for nutritional index,clinical recovery index, complications etc.

Condition or Disease Intervention/Treatment Phase
  • Procedure: perioperational nutrition surpport
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Perioperative Nutritional Status on Enhanced Recovery After Surgery for Gastric Cancer
Anticipated Study Start Date :
Mar 1, 2017
Anticipated Primary Completion Date :
Mar 1, 2021
Anticipated Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Preoperational nutrition support group

Scored patient-generated subjective global assessment(PG-SGA) ≥2，<9 Oral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation

Procedure: perioperational nutrition surpport
Oral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation
No Intervention: Conventional group

PG-SGA ≥2，<9

Outcome Measures

Primary Outcome Measures

  1. complication [30 days after operation]

    fever；wound infection；post-operation bleeding；ileus；stenosis；leakage

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • A preoperative cancer stage of T2, T3, T4, Any N, M0 without digestive obstruction confirmed by whole body CT scan, which could be treated with laparoscopic gastrectomy;

  • age 18-75 years;

  • pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy;

  • normal hematological, renal, hepatic, and cardiac parameters,American Society of Anesthesiology (ASA) score < III without severe systemic disease;

  • no history of treatment with neoadjuvant chemotherapy and/or radiotherapy

  • PG-SGA score ≥2，<9

Exclusion Criteria:

  • patients requiring conversion to open gastrectomy

  • excessive bleeding (˃ 500 mL);and patients opting out of the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • The First Hospital of Jilin University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Quan Wang, Director, The First Hospital of Jilin University
ClinicalTrials.gov Identifier:
NCT03043183
Other Study ID Numbers:
  • ERAS AND Nutritional Status
First Posted:
Feb 3, 2017
Last Update Posted:
Feb 6, 2017
Last Verified:
Feb 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Quan Wang, Director, The First Hospital of Jilin University
gastric cancer
Enhanced recovery after surgery
Additional relevant MeSH terms:
Stomach Neoplasms
Nutrition Disorders

Study Results

No Results Posted as of Feb 6, 2017