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临床试验/NCT07328633
NCT07328633已完成不适用

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

The Affiliated Hospital of Qingdao University1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2024年12月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
136
试验地点
1
主要终点
Incidence of Postoperative Complications

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age:18-75 years
  • 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

排除标准

  • 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

研究组 & 干预措施

ERAS Only

Active Comparator

Participants will receive standard Enhanced Recovery After Surgery (ERAS) protocols without the pre-habilitation program.

干预措施: Enhanced Recovery After Surgery (ERAS) Protocol (Procedure)

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.

干预措施: Pre-habilitation Program (Behavioral)

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.

干预措施: Enhanced Recovery After Surgery (ERAS) Protocol (Procedure)

结局指标

主要结局

Incidence of Postoperative Complications

时间窗: Postoperative 30-day

The primary outcome measure is the incidence of postoperative complications within 30 days after surgery, assessed using the Clavien-Dindo classification system(CDC ≥ II).

次要结局

  • Operation time(Intra-operative)
  • Estimated blood loss(Intra-operative)
  • Pathological ypT stage(At pathology review (within 2 week after surgery))
  • Pathological ypN stage(At pathology review (within 2 week after surgery))
  • AJCC pathological TNM stage(At pathology review (within 2 week after surgery))
  • Tumour regression grade (TRG)(At pathology review (within 2 week after surgery))
  • Time to first flatus(Post-operative period (up to 30 days))
  • Time to first liquid diet(Post-operative period (up to 30 days))
  • Post-operative hospital stay(Post-operative period.)
  • Serum albumin level(Post-operative day 1,3,5.)
  • Tumour differentiation(At pathology review (within 2 week after surgery))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhou Yanbing

chief physician

The Affiliated Hospital of Qingdao University

研究点 (1)

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