Quality of Life After Cytoreductive Surgery and Intraperitoneal Chemotherapy

August 9, 2018 updated by: Soo Yeun Park, Kyungpook National University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients eligible for cytoreductive surgery and intraperitoneal chemotherapy for colorectal cancer peritoneal metastasis or pseudomyxoma peritonei

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months
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
preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months
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
preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months
Postoperative morbidity
Time Frame: 90 days after surgery
Incidence and degree of surgical and medical complications after surgery
90 days after surgery
Postoperative mortality
Time Frame: 90 days after surgery
Incidence of postoperative mortality
90 days after surgery
Postoperative recovery
Time Frame: 150 days after surgery
Duration of hospital stay after surgery
150 days 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
preoperative, postoperative 3 months, postoperative 6 months, postoperative 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Investigators

  • Principal Investigator: Soo Yeun Park, MD, Colorectal Cancer Center, Kyungpook National University Chilgok Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

April 18, 2018

First Posted (Actual)

April 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNUHC03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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