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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Incidence of Postoperative Complications
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age:18-75 years
- •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
Arms & Interventions
ERAS Only
Participants will receive standard Enhanced Recovery After Surgery (ERAS) protocols without the pre-habilitation program.
Intervention: Enhanced Recovery After Surgery (ERAS) Protocol (Procedure)
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.
Intervention: Pre-habilitation Program (Behavioral)
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.
Intervention: Enhanced Recovery After Surgery (ERAS) Protocol (Procedure)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Operation time(Intra-operative)
- Estimated blood loss(Intra-operative)
- Pathological ypT stage(At pathology review (within 2 week after surgery))
- Pathological ypN stage(At pathology review (within 2 week after surgery))
- AJCC pathological TNM stage(At pathology review (within 2 week after surgery))
- Tumour regression grade (TRG)(At pathology review (within 2 week after surgery))
- Time to first flatus(Post-operative period (up to 30 days))
- Time to first liquid diet(Post-operative period (up to 30 days))
- Post-operative hospital stay(Post-operative period.)
- Serum albumin level(Post-operative day 1,3,5.)
- Tumour differentiation(At pathology review (within 2 week after surgery))
Investigators
Zhou Yanbing
chief physician
The Affiliated Hospital of Qingdao University