Clincosm LogoSign in Get a demo

Quality of Life After Cytoreductive Surgery and Intraperitoneal Chemotherapy

Sponsor
Kyungpook National University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT03503071
Collaborator
(none)
50
Enrollment
1
Location
87
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Procedure: Cytoreductive surgery and intraperitoneal chemotherapy

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Recovery of Quality of Life After Cytoreductive Surgery and Intraperitoneal Chemotherapy for Colorectal Cancer and Pseudomyxoma Peritonei
Anticipated Study Start Date :
Oct 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2025

Outcome Measures

Primary Outcome Measures

  1. Brief pain inventory (BPI) [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 [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 [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 [preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months]

    Global measure of health-related quality of life

  4. Postoperative morbidity [90 days after surgery]

    Incidence and degree of surgical and medical complications after surgery

  5. Postoperative mortality [90 days after surgery]

    Incidence of postoperative mortality

  6. Postoperative recovery [150 days after surgery]

    Duration of hospital stay after surgery

  7. Brief pain inventory (BPI) [preoperative, postoperative 3 months, postoperative 6 months, postoperative 24 months]

    Pain recovery after cytoreductive surgery and intraperitoneal chemotherapy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Kyungpook National University Chilgok Hospital Daegu Korea, Republic of 41404

Sponsors and Collaborators

  • Kyungpook National University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Soo Yeun Park, Principal investigator, Kyungpook National University Hospital
ClinicalTrials.gov Identifier:
NCT03503071
Other Study ID Numbers:
  • KNUHC03
First Posted:
Apr 19, 2018
Last Update Posted:
Aug 10, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Colorectal Neoplasms

Study Results

No Results Posted as of Aug 10, 2018