Prehabilitation Plus ERAS in Gastric Cancer Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-05

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastric Cancer (GC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Pre-habilitation Program

Intervention Type BEHAVIORAL

A 4-week pre-habilitation program including exercise, nutrition, and psychological support aimed at improving physical and mental readiness for surgery.

Enhanced Recovery After Surgery (ERAS) Protocol

Intervention Type PROCEDURE

Standard protocols for Enhanced Recovery After Surgery aimed at reducing postoperative complications and accelerating recovery.

ERAS Only

Participants will receive standard Enhanced Recovery After Surgery (ERAS) protocols without the pre-habilitation program.

Group Type ACTIVE_COMPARATOR

Enhanced Recovery After Surgery (ERAS) Protocol

Intervention Type PROCEDURE

Standard protocols for Enhanced Recovery After Surgery aimed at reducing postoperative complications and accelerating recovery.

Interventions

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Pre-habilitation Program

A 4-week pre-habilitation program including exercise, nutrition, and psychological support aimed at improving physical and mental readiness for surgery.

Intervention Type BEHAVIORAL

Enhanced Recovery After Surgery (ERAS) Protocol

Standard protocols for Enhanced Recovery After Surgery aimed at reducing postoperative complications and accelerating recovery.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No