Quality of Life After Cytoreductive Surgery and Intraperitoneal Chemotherapy

NCT03503071 | Unknown

• 1 other identifier: KNUHC03
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Brief pain inventory (BPI)

  Pain recovery after cytoreductive surgery and intraperitoneal chemotherapy

  Changes from baseline pain scores at postoperative 12 months

Secondary Outcomes (7)

• 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

• EORTC QLQ for colorectal cancer

  preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months

• Short-form(SF)-36

  preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months

• Postoperative morbidity

  90 days after surgery

• Postoperative mortality

  90 days after surgery

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kyungpook National University Hospital: lead

Study Sites (1)

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

MeSH Terms

Interventions

Cytoreduction Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Soo Yeun Park, MD

  Colorectal Cancer Center, Kyungpook National University Chilgok Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soo Yeun Park, MD

CONTACT

+82-10-8575-9619; psy-flower@daum.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 19, 2018
• Study Start: October 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2025
• Last Updated: August 10, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)