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

Primary Purpose

Nutrition Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
perioperational nutrition surpport
Sponsored by
The First Hospital of Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nutrition Disorders focused on measuring gastric cancer, Enhanced recovery after surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Preoperational nutrition support group

    Conventional group

    Arm Description

    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

    PG-SGA ≥2，<9

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 2, 2017
    Last Updated
    February 3, 2017
    Sponsor
    The First Hospital of Jilin University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03043183
    Brief Title
    Enhanced Recovery After Surgery(ERAS) for Gastric Cancer and Perioperative Nutritional Status
    Official Title
    The Effect of Perioperative Nutritional Status on Enhanced Recovery After Surgery for Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2017 (Anticipated)
    Primary Completion Date
    March 1, 2021 (Anticipated)
    Study Completion Date
    September 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The First Hospital of Jilin University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nutrition Disorders
    Keywords
    gastric cancer, Enhanced recovery after surgery

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    1400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Preoperational nutrition support group
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Conventional group
    Arm Type
    No Intervention
    Arm Description
    PG-SGA ≥2，<9
    Intervention Type
    Procedure
    Intervention Name(s)
    perioperational nutrition surpport
    Intervention Description
    Oral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation
    Primary Outcome Measure Information:
    Title
    complication
    Description
    fever；wound infection；post-operation bleeding；ileus；stenosis；leakage
    Time Frame
    30 days after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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

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