Early Postoperative Intervention in Gastric Cancer Patients

NCT07444099 | Enrolling By Invitation DMC

• 1 other identifier: KYLL-202501-049-1
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gastric Cancer (GC); Postoperative Recovery

Keywords

gastric cancer; postoperative care; postoperative complications; recover quality

Outcome Measures

Primary Outcomes (2)

• incidence of complications within 30 days postoperatively

  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.

  30 days after operation

• Postoperative recovery quality

  Postoperative recovery quality was assessed using The 15-item Quality of Recovery Score scale, with a maximum score of 150 points and a minimum score of 0 points, where higher scores indicate better postoperative recovery quality

  Baseline (Day of Discharge) and POD 30（30 days after surgery）

Secondary Outcomes (5)

• Readmission or emergency department visit rate within 30 days postoperatively

  30 days after surgery

• Time interval between surgery and initiation of adjuvant chemotherapy

  6 month after surgery

• Completion rate of postoperative chemotherapy / Adherence to adjuvant chemotherapy

  6 month after surgery

• Grading of chemotherapy-related adverse events

  6 month after surgery

• Postoperative quality of life score

  Baseline (Day of Discharge) and POD 30（30 days after surgery）

Study Arms (2)

Patients with early structured postoperative intervention

EXPERIMENTAL

Combination Product: Early structured postoperative intervention encompassing nutrition, psychology, and exercise

Patients without early structured postoperative intervention

NO INTERVENTION

Interventions

Early structured postoperative intervention encompassing nutrition, psychology, and exercise COMBINATION_PRODUCT

Nutritional intervention: Routine postoperative oral nutritional supplements (ONS) will be provided, and patients with metabolic diseases such as diabetes will undergo strict glycemic control. Psychological intervention: Patients with a Hospital Anxiety and Depression Scale (HADS) score ≥ 8 will receive cognitive behavioral therapy (CBT), and those with a HADS score ≥ 11 will be referred for psychological consultation. Exercise intervention: Postoperative rehabilitation training will be guided according to different postoperative periods.

Patients with early structured postoperative intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Linyi People's Hospital: collaborator
• Liaocheng People's Hospital: collaborator
• Yantai Yuhuangding Hospital: collaborator
• Central Hospital of Zibo: collaborator
• Weifang People's Hospital: collaborator

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (5)

• Basch 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 BACKGROUND

• Gillis 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 BACKGROUND

• Michard 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 BACKGROUND

• Tian 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 BACKGROUND

• Sauro 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 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms; Postoperative Complications

Interventions

Psychology; Exercise

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 2, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months and ending 36 months following publication
• Access Criteria: Data will be made available to researchers who provide a methodologically sound proposal, subject to approval by an independent review committee and execution of a data use agreement.

Locations

CN (1)