Quality of Life After Cytoreductive Surgery and Intraperitoneal Chemotherapy

Overview

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.

Full Title of Study: “Recovery of Quality of Life After Cytoreductive Surgery and Intraperitoneal Chemotherapy for Colorectal Cancer and Pseudomyxoma Peritonei”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2020

Interventions

  • Procedure: Cytoreductive surgery and intraperitoneal chemotherapy
    • Cytoreductive surgery and intraperitoneal chemotherapy for colorectal cancer or pseudomyxoma peritonei. Either early postoperative intraperitoneal chemotherapy (EPIC) or hyperthermic intraperitoneal chemotherapy (HIPEC) is used for intraperitoneal chemotherapy.

Clinical Trial Outcome Measures

Primary Measures

  • Brief pain inventory (BPI)
    • Time Frame: Changes from baseline pain scores at postoperative 12 months
    • Pain recovery after cytoreductive surgery and intraperitoneal chemotherapy

Secondary Measures

  • European Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ)-C30
    • Time Frame: preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months
    • Qualify of life questionnaire for cancer patients
  • EORTC QLQ for colorectal cancer
    • Time Frame: preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months
    • Quality of life questionnaire for patients with colorectal cancer
  • Short-form(SF)-36
    • Time Frame: preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months
    • Global measure of health-related quality of life
  • Postoperative morbidity
    • Time Frame: 90 days after surgery
    • Incidence and degree of surgical and medical complications after surgery
  • Postoperative mortality
    • Time Frame: 90 days after surgery
    • Incidence of postoperative mortality
  • Postoperative recovery
    • Time Frame: 150 days after surgery
    • Duration of hospital stay after surgery
  • Brief pain inventory (BPI)
    • Time Frame: preoperative, postoperative 3 months, postoperative 6 months, postoperative 24 months
    • Pain recovery after cytoreductive surgery and intraperitoneal chemotherapy

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kyungpook National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Soo Yeun Park, Principal investigator – Kyungpook National University Hospital
  • Overall Official(s)
    • Soo Yeun Park, MD, Principal Investigator, Colorectal Cancer Center, Kyungpook National University Chilgok Hospital
  • Overall Contact(s)
    • Soo Yeun Park, MD, +82-10-8575-9619, psy-flower@daum.net

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.