Prehabilitation Plus ERAS in Gastric Cancer Surgery

December 26, 2025 updated by: Zhou Yanbing, The Affiliated Hospital of Qingdao University

Effect of Pre-habilitation Combined With Enhanced Recovery After Surgery (ERAS) Versus ERAS Perioperative Management on Clinical Outcomes of Laparoscopic (Robotic) Gastrectomy in Patients With Gastric Cancer Receiving Neoadjuvant Chemotherapy: A Single-center Randomized Controlled Trial

This study aims to evaluate the impact of pre-habilitation combined with Enhanced Recovery After Surgery (ERAS) versus ERAS perioperative management alone on clinical outcomes in patients with gastric cancer undergoing neoadjuvant chemotherapy and laparoscopic (robotic) gastrectomy. The study is a single-center, randomized controlled trial involving patients aged 18-75 years. Participants will be randomly assigned to either a pre-habilitation program plus ERAS or ERAS alone. The primary outcome is the incidence of postoperative complications within 30 days. Secondary outcomes include pathological data, surgical outcomes, patient-reported outcomes, and long-term survival rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study is designed as a prospective, single-center, randomized, open-label, controlled clinical trial to compare the effects of pre-habilitation combined with ERAS versus ERAS alone in patients undergoing laparoscopic (robotic) gastrectomy after neoadjuvant chemotherapy for gastric cancer. The study will enroll patients aged 18-75 years who are scheduled for laparoscopic (robotic) gastrectomy following neoadjuvant chemotherapy. Participants will be randomly assigned in a 1:1 ratio to either the pre-habilitation plus ERAS group or the ERAS group. The pre-habilitation program will include a 4-week intervention involving exercise, nutrition, and psychological support prior to surgery. The primary endpoint is the incidence of postoperative complications within 30 days, assessed using the Clavien-Dindo classification. Secondary endpoints include pathological characteristics, surgical outcomes, patient-reported outcomes, and long-term survival rates. Data will be collected from patient records and follow-up visits. Statistical analysis will be performed using SPSS 26.0 or later versions, with significance level set at α=0.05.

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266000
        • The Affiliated Hospital of Qingdao University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age:18-75 years
  • ECOG:0-2
  • ASA:I-III
  • Histologically confirmed gastric adenocarcinoma (cT3-4aN+M0)
  • Fit for radical surgery after MDT
  • Negative pregnancy test within one month
  • Non-pregnant or non-lactating

Exclusion Criteria:

  • Severe cardiac (LVEF<30% or NYHA IV)
  • Severe hepatic or renal dysfunction (Child-Pugh ≥10; CrCl<25 ml/min)
  • Recent cerebrovascular events
  • Concomitant tumors requiring surgery
  • Emergency surgery for tumor complications,
  • Severe infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pre-habilitation + ERAS
Participants will undergo a 4-week pre-habilitation program including exercise, nutrition, and psychological support, followed by Enhanced Recovery After Surgery (ERAS) protocols.
Behavioral: Pre-habilitation Program
A 4-week pre-habilitation program including exercise, nutrition, and psychological support aimed at improving physical and mental readiness for surgery.
Procedure: Enhanced Recovery After Surgery (ERAS) Protocol
Standard protocols for Enhanced Recovery After Surgery aimed at reducing postoperative complications and accelerating recovery.
Active Comparator: ERAS Only
Participants will receive standard Enhanced Recovery After Surgery (ERAS) protocols without the pre-habilitation program.
Procedure: Enhanced Recovery After Surgery (ERAS) Protocol
Standard protocols for Enhanced Recovery After Surgery aimed at reducing postoperative complications and accelerating recovery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Postoperative Complications
Time Frame: Postoperative 30-day
The primary outcome measure is the incidence of postoperative complications within 30 days after surgery, assessed using the Clavien-Dindo classification system(CDC ≥ II).
Postoperative 30-day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: Intra-operative
Time from skin incision to skin closure. Unit: minutes.
Intra-operative
Estimated blood loss
Time Frame: Intra-operative
Total volume of intra-operative blood loss. Unit: mL.
Intra-operative
Pathological ypT stage
Time Frame: At pathology review (within 2 week after surgery)

Tumour infiltration depth in the resection specimen according to AJCC 8th edition.

Unit: n (%) - categories T0, T1, T2, T3, T4.
At pathology review (within 2 week after surgery)
Pathological ypN stage
Time Frame: At pathology review (within 2 week after surgery)
Number of metastatic lymph nodes in the resection specimen. Unit: n (%) - categories N0, N1, N2, N3.
At pathology review (within 2 week after surgery)
AJCC pathological TNM stage
Time Frame: At pathology review (within 2 week after surgery)
Combined pathological stage. Unit: n (%) - stages I, II, III.
At pathology review (within 2 week after surgery)
Tumour regression grade (TRG)
Time Frame: At pathology review (within 2 week after surgery)
Degree of tumour response to neoadjuvant therapy according to Mandard criteria. Unit: n (%) - grades 0, 1, 2, 3.
At pathology review (within 2 week after surgery)
Time to first flatus
Time Frame: Post-operative period (up to 30 days)
Interval from end of surgery to first rectal gas passage. Unit: days.
Post-operative period (up to 30 days)
Time to first liquid diet
Time Frame: Post-operative period (up to 30 days)
Interval from end of surgery to first tolerated liquid intake. Unit: days.
Post-operative period (up to 30 days)
Post-operative hospital stay
Time Frame: Post-operative period.
Interval from surgery to hospital discharge. Unit: days.
Post-operative period.
Serum albumin level
Time Frame: Post-operative day 1,3,5.
Serum albumin measured post-operatively. Unit: g/L.
Post-operative day 1,3,5.
Tumour differentiation
Time Frame: At pathology review (within 2 week after surgery)
Histological grade of the tumour. Unit: n (%) - well / moderate / poor.
At pathology review (within 2 week after surgery)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sex distribution
Time Frame: Baseline (day of enrollment)
Biological sex at enrollment Unit: n (%) - Male, Female
Baseline (day of enrollment)
Height
Time Frame: Baseline (day of enrollment)
Body height measured without shoes Unit: cm
Baseline (day of enrollment)
Weight
Time Frame: Baseline (day of enrollment)
Body weight measured in light indoor clothing Unit: kg
Baseline (day of enrollment)
ECOG performance status
Time Frame: Baseline (day of enrollment)
Eastern Cooperative Oncology Group performance score Unit: n (%) - scores 0, 1, 2
Baseline (day of enrollment)
Nutritional risk score (NRS 2002)
Time Frame: Baseline (day of enrollment)
Nutritional Risk Screening 2002 total score Unit: n (%) - <3 vs ≥3
Baseline (day of enrollment)
ASA physical status classification
Time Frame: Baseline (day of enrollment)
American Society of Anesthesiologists classification Unit: n (%) - classes 1, 2, 3
Baseline (day of enrollment)
Tumor diameter
Time Frame: Baseline (after neoadjuvant therapy, before surgery)
Maximum diameter of the primary tumor on pre-operative imaging Unit: cm
Baseline (after neoadjuvant therapy, before surgery)
Clinical T stage
Time Frame: Baseline (after neoadjuvant therapy, before surgery)
Clinical T category per AJCC 8th edition Unit: n (%) - cT2, cT3, cT4
Baseline (after neoadjuvant therapy, before surgery)
Clinical N stage
Time Frame: Baseline (after neoadjuvant therapy, before surgery)
Clinical N category per AJCC 8th edition Unit: n (%) - cN0, cN1, cN2, cN3
Baseline (after neoadjuvant therapy, before surgery)
Six-minute walk test distance
Time Frame: Baseline (after neoadjuvant therapy, before surgery)
Distance walked in 6 minutes on indoor flat track Unit: meters
Baseline (after neoadjuvant therapy, before surgery)
Hospital Anxiety and Depression Scale (HADS)
Time Frame: From the end of neoadjuvant therapy to the day before surgery, assessed up to 42 days.

Anxiety and depression symptoms assessed with the 14-item HADS questionnaire; total score 0-21, higher scores indicate greater symptom severity.

Unit: score (0-21)
From the end of neoadjuvant therapy to the day before surgery, assessed up to 42 days.
Health-related quality of life (EORTC QLQ-C30)
Time Frame: From the end of neoadjuvant therapy to the day before surgery, assessed up to 42 days.

Assessed with the 30-item EORTC QLQ-C30 questionnaire; 15 domains (5 functional, 9 symptom/single-item, 1 global QoL). Raw scores are linearly transformed to 0-100 standard scores. Higher functional/global scores = better QoL; higher symptom scores = worse symptoms.

Unit: score (0-100)
From the end of neoadjuvant therapy to the day before surgery, assessed up to 42 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of Qingdao University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2024

Primary Completion (Actual)

August 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

September 19, 2025

First Submitted That Met QC Criteria

December 26, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

December 26, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QYFYEC2025-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) including baseline demographics, intervention details, and all primary/secondary outcomes will be shared. No participant identifiers will be included.

IPD Sharing Time Frame

Start date:Main results publication date. End date:5 years after publication.

IPD Sharing Access Criteria

Data will be available to qualified researchers upon reasonable request. Requests should be sent to 17866805578@163.com with a brief research proposal. A data-sharing agreement is required. Data will be provided in CSV format within 3 months of request approval.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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