Clinical trial · Interventional
Prehabilitation Plus ERAS in Gastric Cancer Surgery
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer (GC) | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enhanced Recovery After Surgery (ERAS) Protocol | Procedure | — | UNRESOLVED |
| Pre-habilitation Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pre-habilitation + ERAS
- description
- Participants will undergo a 4-week pre-habilitation program including exercise, nutrition, and psychological support, followed by Enhanced Recovery After Surgery (ERAS) protocols.
- interventionNames
- Behavioral: Pre-habilitation Program
- Procedure: Enhanced Recovery After Surgery (ERAS) Protocol
- type
- ACTIVE_COMPARATOR
- label
- ERAS Only
- description
- Participants will receive standard Enhanced Recovery After Surgery (ERAS) protocols without the pre-habilitation program.
- interventionNames
- Procedure: Enhanced Recovery After Surgery (ERAS) Protocol
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (5)
- RESULTAjani JA, Bentrem DJ, Besh S, D'Amico TA, Das P, Denlinger C, Fakih MG, Fuchs CS, Gerdes H, Glasgow RE, Hayman JA, Hofstetter WL, Ilson DH, Keswani RN, Kleinberg LR, Korn WM, Lockhart AC, Meredith K, Mulcahy MF, Orringer MB, Posey JA, Sasson AR, Scott WJ, Strong VE, Varghese TK Jr, Warren G, Washington MK, Willett C, Wright CD, McMillian NR, Sundar H; National Comprehensive Cancer Network. Gastric cancer, version 2.2013: featured updates to the NCCN Guidelines. J Natl Compr Canc Netw. 2013 May 1;11(5):531-46. doi: 10.6004/jnccn.2013.0070. PMID 23667204
- RESULTSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- RESULTXing J, Wang Y, Shan F, Li S, Jia Y, Ying X, Zhang Y, Li Z, Ji J. Comparison of totally laparoscopic and laparoscopic assisted gastrectomy after neoadjuvant chemotherapy in locally advanced gastric cancer. Eur J Surg Oncol. 2021 Aug;47(8):2023-2030. doi: 10.1016/j.ejso.2021.02.002. Epub 2021 Feb 6. PMID 33663942
- RESULTZhong H, Liu X, Tian Y, Cao S, Li Z, Liu G, Sun Y, Zhang X, Han Z, Meng C, Jia Z, Wang Q, Zhou Y. Comparison of short- and long-term outcomes between laparoscopic and open gastrectomy for locally advanced gastric cancer following neoadjuvant chemotherapy: a propensity score matching analysis. Surg Endosc. 2023 Aug;37(8):5902-5915. doi: 10.1007/s00464-023-10052-7. Epub 2023 Apr 18. PMID 37072637
- RESULTLiu G, Cao S, Liu X, Tian Y, Li Z, Sun Y, Zhong H, Wang K, Zhou Y. Short- and long-term outcomes following perioperative ERAS management in patients undergoing minimally invasive radical gastrectomy after neoadjuvant chemotherapy: A single-center retrospective propensity score matching study. Eur J Surg Oncol. 2025 Jan;51(1):109459. doi: 10.1016/j.ejso.2024.109459. Epub 2024 Nov 15. PMID 39566200