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Quality of Life After Cytoreductive Surgery and Intraperitoneal Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03503071
Recruitment Status : Not yet recruiting
First Posted : April 19, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Soo Yeun Park, Kyungpook National University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Colorectal Cancer Metastatic Procedure: Cytoreductive surgery and intraperitoneal chemotherapy

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Recovery of Quality of Life After Cytoreductive Surgery and Intraperitoneal Chemotherapy for Colorectal Cancer and Pseudomyxoma Peritonei
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients eligible for cytoreductive surgery and intraperitoneal chemotherapy for colorectal cancer peritoneal metastasis or pseudomyxoma peritonei
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503071


Contacts
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Contact: Soo Yeun Park, MD +82-10-8575-9619 psy-flower@daum.net

Locations
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Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu, Korea, Republic of, 41404
Contact: Soo Yeun Park, MD    +82-10-8575-9619    psy-flower@daum.net   
Sponsors and Collaborators
Kyungpook National University Hospital
Investigators
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Principal Investigator: Soo Yeun Park, MD Colorectal Cancer Center, Kyungpook National University Chilgok Hospital
More Information
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Additional Information:

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Responsible Party: Soo Yeun Park, Principal investigator, Kyungpook National University Hospital
ClinicalTrials.gov Identifier: NCT03503071    
Other Study ID Numbers: KNUHC03
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases