Clinical trial · Interventional
Early Postoperative Intervention in Gastric Cancer Patients
Early Postoperative Structured Intervention for Quality of Life and Prognosis in Gastric Cancer Patients After Neoadjuvant Therapy：: A Multicenter,Open Label Randomized Controlled Trial
NCT07444099CI-TRIAL-00104372enrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 was conducted by Qilu Hospital and five other renowned medical centers, aiming to evaluate the impact of early structured postoperative intervention on quality of life and prognosis in patients with gastric cancer after neoadjuvant therapy.
Conditions
Conditions (2)
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 |
| Postoperative Recovery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early structured postoperative intervention encompassing nutrition, psychology, and exercise | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patients with early structured postoperative intervention
- interventionNames
- Combination Product: Early structured postoperative intervention encompassing nutrition, psychology, and exercise
- type
- NO_INTERVENTION
- label
- Patients without early structured postoperative intervention
Primary outcomes (2)
- measure
- incidence of complications within 30 days postoperatively
- timeFrame
- 30 days after operation
- description
- The incidence of complications within 30 days postoperatively was calculated as the number of patients who developed complications within 30 days after surgery divided by the total number of patients in that group.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-80 years; * Histologically confirmed adenocarcinoma by preoperative pathology; * Completed preoperative neoadjuvant therapy without obvious immune-related adverse events (irAEs); * Patients with ycT3-4N+Mx disease deemed surgically resectable based on evaluation by gastroscopy, CT, PET-CT, and other imaging modalities; * Signed informed consent and voluntary participation in this study; * Standard ERAS (Enhanced Recovery After Surgery) management during the - perioperative period, with postoperative hospital stay ≤7 days. Exclusion Criteria: * Patients with central nervous system diseases or psychiatric disorders; * Patients with severe diseases of other organ systems; * Patients with recurrent infectious diseases or severe comorbidities; * Patients requiring synchronous surgery for other diseases; * Patients undergoing emergency surgery; * Patients who developed any complication during hospitalization.
References
Publications (5)
- BACKGROUNDBasch E. Patient-Reported Outcomes - Harnessing Patients' Voices to Improve Clinical Care. N Engl J Med. 2017 Jan 12;376(2):105-108. doi: 10.1056/NEJMp1611252. No abstract available. PMID 28076708
- BACKGROUNDGillis C, Ljungqvist O, Carli F. Prehabilitation, enhanced recovery after surgery, or both? A narrative review. Br J Anaesth. 2022 Mar;128(3):434-448. doi: 10.1016/j.bja.2021.12.007. Epub 2022 Jan 7. PMID 35012741
- BACKGROUNDMichard F, Thiele RH, Le Guen M. One small wearable, one giant leap for patient safety? J Clin Monit Comput. 2022 Feb;36(1):1-4. doi: 10.1007/s10877-021-00767-0. Epub 2021 Oct 19. No abstract available. PMID 34665392
- BACKGROUNDTian Y, Cao S, Liu X, Li L, He Q, Jiang L, Wang X, Chu X, Wang H, Xia L, Ding Y, Mao W, Hui X, Shi Y, Zhang H, Niu Z, Li Z, Jiang H, Kehlet H, Zhou Y. Randomized Controlled Trial Comparing the Short-term Outcomes of Enhanced Recovery After Surgery and Conventional Care in Laparoscopic Distal Gastrectomy (GISSG1901). Ann Surg. 2022 Jan 1;275(1):e15-e21. doi: 10.1097/SLA.0000000000004908. PMID 33856385
- BACKGROUNDSauro KM, Smith C, Ibadin S, Thomas A, Ganshorn H, Bakunda L, Bajgain B, Bisch SP, Nelson G. Enhanced Recovery After Surgery Guidelines and Hospital Length of Stay, Readmission, Complications, and Mortality: A Meta-Analysis of Randomized Clinical Trials. JAMA Netw Open. 2024 Jun 3;7(6):e2417310. doi: 10.1001/jamanetworkopen.2024.17310. PMID 38888922