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NCT Number: NCT03503071

Quality of Life After Cytoreductive Surgery and Intraperitoneal Chemotherapy

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.

Why the study stopped: protocol change
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Key information

Conditions

Colorectal Cancer Metastatic

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytoreductive surgery and intraperitoneal chemotherapy

Procedure

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.

Primary outcomes

  1. Brief pain inventory (BPI)

    Time frame: Changes from baseline pain scores at postoperative 12 months

    Pain recovery after cytoreductive surgery and intraperitoneal chemotherapy

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Postoperative morbidity

    Time frame: 90 days after surgery

    Incidence and degree of surgical and medical complications after surgery

  5. Postoperative mortality

    Time frame: 90 days after surgery

    Incidence of postoperative mortality

  6. Postoperative recovery

    Time frame: 150 days after surgery

    Duration of hospital stay after surgery

  7. Brief pain inventory (BPI)

    Time frame: preoperative, postoperative 3 months, postoperative 6 months, postoperative 24 months

    Pain recovery after cytoreductive surgery and intraperitoneal chemotherapy

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2025
First posted
Apr 19, 2018
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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