Prehabilitation Plus ERAS in Gastric Cancer Surgery

Qingdao University

Status: Completed

Conditions: Gastric Cancer (GC)

Treatments: Procedure: Enhanced Recovery After Surgery (ERAS) Protocol; Behavioral: Pre-habilitation Program

Study type: Interventional

Funder types: Other

Identifiers

NCT07328633

QYFYEC2025-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Pre-habilitation + ERAS

Experimental group

Description:

Participants will undergo a 4-week pre-habilitation program including exercise, nutrition, and psychological support, followed by Enhanced Recovery After Surgery (ERAS) protocols.

Treatment:

Behavioral: Pre-habilitation Program

Procedure: Enhanced Recovery After Surgery (ERAS) Protocol

ERAS Only

Active Comparator group

Description:

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

Treatment:

Procedure: Enhanced Recovery After Surgery (ERAS) Protocol