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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-habilitation + ERAS | Experimental | Participants will undergo a 4-week pre-habilitation program including exercise, nutrition, and psychological support, followed by Enhanced Recovery After Surgery (ERAS) protocols. |
|
| ERAS Only | Active Comparator | Participants will receive standard Enhanced Recovery After Surgery (ERAS) protocols without the pre-habilitation program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-habilitation Program | Behavioral | A 4-week pre-habilitation program including exercise, nutrition, and psychological support aimed at improving physical and mental readiness for surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Postoperative 30-day |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | Time from skin incision to skin closure. Unit: minutes. | Intra-operative |
| Estimated blood loss | Total volume of intra-operative blood loss. Unit: mL. |
| Measure | Description | Time Frame |
|---|---|---|
| Sex distribution | Biological sex at enrollment Unit: n (%) - Male, Female | Baseline (day of enrollment) |
| Height | Body height measured without shoes Unit: cm |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23667204 | Result | Ajani 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. | |
| 33538338 |
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De-identified individual participant data (IPD) including baseline demographics, intervention details, and all primary/secondary outcomes will be shared. No participant identifiers will be included.
Start date:Main results publication date. End date:5 years after publication.
Data will be available to qualified researchers upon reasonable request. Requests should be sent to 17866805578@163.com with a brief research proposal. A data-sharing agreement is required. Data will be provided in CSV format within 3 months of request approval.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 27, 2024 | Dec 1, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 27, 2024 | Dec 1, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000080482 | Enhanced Recovery After Surgery |
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D013514 | Surgical Procedures, Operative |
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
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| Enhanced Recovery After Surgery (ERAS) Protocol | Procedure | Standard protocols for Enhanced Recovery After Surgery aimed at reducing postoperative complications and accelerating recovery. |
|
| 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. | 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. | At pathology review (within 2 week after surgery) |
| AJCC pathological TNM stage | Combined pathological stage. Unit: n (%) - stages I, II, III. | 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. | At pathology review (within 2 week after surgery) |
| Time to first flatus | Interval from end of surgery to first rectal gas passage. Unit: days. | Post-operative period (up to 30 days) |
| Time to first liquid diet | Interval from end of surgery to first tolerated liquid intake. Unit: days. | Post-operative period (up to 30 days) |
| Post-operative hospital stay | Interval from surgery to hospital discharge. Unit: days. | Post-operative period. |
| Serum albumin level | Serum albumin measured post-operatively. Unit: g/L. | Post-operative day 1,3,5. |
| Tumour differentiation | Histological grade of the tumour. Unit: n (%) - well / moderate / poor. | At pathology review (within 2 week after surgery) |
| Baseline (day of enrollment) |
| Weight | Body weight measured in light indoor clothing Unit: kg | Baseline (day of enrollment) |
| ECOG performance status | Eastern Cooperative Oncology Group performance score Unit: n (%) - scores 0, 1, 2 | Baseline (day of enrollment) |
| Nutritional risk score (NRS 2002) | Nutritional Risk Screening 2002 total score Unit: n (%) - <3 vs ≥3 | Baseline (day of enrollment) |
| ASA physical status classification | American Society of Anesthesiologists classification Unit: n (%) - classes 1, 2, 3 | Baseline (day of enrollment) |
| Tumor diameter | Maximum diameter of the primary tumor on pre-operative imaging Unit: cm | Baseline (after neoadjuvant therapy, before surgery) |
| Clinical T stage | Clinical T category per AJCC 8th edition Unit: n (%) - cT2, cT3, cT4 | Baseline (after neoadjuvant therapy, before surgery) |
| Clinical N stage | Clinical N category per AJCC 8th edition Unit: n (%) - cN0, cN1, cN2, cN3 | Baseline (after neoadjuvant therapy, before surgery) |
| Six-minute walk test distance | Distance walked in 6 minutes on indoor flat track Unit: meters | Baseline (after neoadjuvant therapy, before surgery) |
| Hospital Anxiety and Depression Scale (HADS) | Anxiety and depression symptoms assessed with the 14-item HADS questionnaire; total score 0-21, higher scores indicate greater symptom severity. Unit: score (0-21) | From the end of neoadjuvant therapy to the day before surgery, assessed up to 42 days. |
| Health-related quality of life (EORTC QLQ-C30) | Assessed with the 30-item EORTC QLQ-C30 questionnaire; 15 domains (5 functional, 9 symptom/single-item, 1 global QoL). Raw scores are linearly transformed to 0-100 standard scores. Higher functional/global scores = better QoL; higher symptom scores = worse symptoms. Unit: score (0-100) | From the end of neoadjuvant therapy to the day before surgery, assessed up to 42 days. |
| Result |
| Sung 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. |
| 33663942 | Result | Xing 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. |
| 37072637 | Result | Zhong 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. |
| 39566200 | Result | Liu 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. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |