跳至主要内容
临床试验/NCT03503071
NCT03503071撤回不适用

Recovery of Quality of Life After Cytoreductive Surgery and Intraperitoneal Chemotherapy for Colorectal Cancer and Pseudomyxoma Peritonei

Kyungpook National University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
50
试验地点
1
主要终点
Brief pain inventory (BPI)

研究概览

简要总结

Cytoreductive surgery with intraperitoneal chemotherapy is one of the most important treatments for patients with colorectal cancer and peritoneal metastasis. For the best survival rates, complete removal of all metastatic lesions is the most important part of treatment, and various surgical procedures are required for the complete cytoreduction. Therefore, the postoperative morbidity rates are higher than those of localized colon cancer surgeries and patients can experience a prolonged recovery period and deterioration of physical activities over a long period. The aim of this study is to investigate the change of quality of life after cytoreductive surgery and intraperitoneal chemotherapy for colorectal cancer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Colorectal cancer peritoneal metastasis
  • •Pseudomyxoma peritonei
  • •ECOG (Eastern Cooperative Oncology Group) performance status 0-3
  • •Normal bone marrow, kidney, and liver function
  • •Patient must sign and date the informed consent

排除标准

  • •Palliative surgery
  • •Palliative intraperitoneal chemotherapy
  • •Psychotic disorder
  • •Drug abuser

结局指标

主要结局

Brief pain inventory (BPI)

时间窗: Changes from baseline pain scores at postoperative 12 months

Pain recovery after cytoreductive surgery and intraperitoneal chemotherapy

次要结局

  • European Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ)-C30(preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months)
  • EORTC QLQ for colorectal cancer(preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months)
  • Postoperative recovery(150 days after surgery)
  • Short-form(SF)-36(preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months)
  • Postoperative morbidity(90 days after surgery)
  • Postoperative mortality(90 days after surgery)
  • Brief pain inventory (BPI)(preoperative, postoperative 3 months, postoperative 6 months, postoperative 24 months)

研究者

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

Soo Yeun Park

Principal investigator

Kyungpook National University Hospital

研究点 (1)

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