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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
A 4-week pre-habilitation program including exercise, nutrition, and psychological support aimed at improving physical and mental readiness for surgery.
Standard protocols for Enhanced Recovery After Surgery aimed at reducing postoperative complications and accelerating recovery.
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Incidence of Postoperative Complications
The primary outcome measure is the incidence of postoperative complications within 30 days after surgery, assessed using the Clavien-Dindo classification system(CDC ≥ II).
Time frame: Postoperative 30-day
Operation time
Time from skin incision to skin closure. Unit: minutes.
Time frame: Intra-operative
Estimated blood loss
Total volume of intra-operative blood loss. Unit: mL.
Time frame: Intra-operative
Pathological ypT stage
Tumour infiltration depth in the resection specimen according to AJCC 8th edition. Unit: n (%) - categories T0, T1, T2, T3, T4.
Time frame: At pathology review (within 2 week after surgery)
Pathological ypN stage
Number of metastatic lymph nodes in the resection specimen. Unit: n (%) - categories N0, N1, N2, N3.
Time frame: At pathology review (within 2 week after surgery)
AJCC pathological TNM stage
Combined pathological stage. Unit: n (%) - stages I, II, III.
Time frame: At pathology review (within 2 week after surgery)
Tumour regression grade (TRG)
Degree of tumour response to neoadjuvant therapy according to Mandard criteria. Unit: n (%) - grades 0, 1, 2, 3.
Time frame: At pathology review (within 2 week after surgery)
Time to first flatus
Interval from end of surgery to first rectal gas passage. Unit: days.
Time frame: Post-operative period (up to 30 days)
Time to first liquid diet
Interval from end of surgery to first tolerated liquid intake. Unit: days.
Time frame: Post-operative period (up to 30 days)
Post-operative hospital stay
Interval from surgery to hospital discharge. Unit: days.
Time frame: Post-operative period.
Serum albumin level
Serum albumin measured post-operatively. Unit: g/L.
Time frame: Post-operative day 1,3,5.
Tumour differentiation
Histological grade of the tumour. Unit: n (%) - well / moderate / poor.
Time frame: At pathology review (within 2 week after surgery)
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