Late Organ Specific Adverse Effects hiPec or pElvic eXenteration (LOSAPEX)

University of Aarhus

Status: Enrolling

Conditions: Colorectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04970316

LOSAPEX

Details and patient eligibility

About

The purpose of this study is to describe type and extent of organ specific late adverse effects in patients undergoing surgery for colorectal cancer with peritoneal metastases and after surgery for colorectal cancer with involvement of the urinary bladder.

Full description

After being informed about the study all patients giving written informed consent will be distributed a questionnaire asking questions on bowel function, urinary function, pain, sexual function and lymphedema. All these aspects will be investigated using validated questionnaires.

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have undergone intended curative CRS+HIPEC for peritoneal metastases originated from colorectal cancer (HIPEC cohort) according to national Danish guidelines
• Patients who have undergone intended curative total or anterior pelvic exenteration (PE cohort) for advanced or recurrent colorectal cancer according to national Danish guidelines

Exclusion criteria

• Patients under 18 years
• Patients not speaking Danish or Swedish, respectively, in Denmark and Sweden
• Patients unable to give informed consent
• Patients undergoing CRS+HIPEC or PE for cancers others than CRC
• Terminally ill patients

Trial design

225 participants in 2 patient groups

HIPEC cohort

Description:

Patients undergoing cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer with peritoneal metastases

PE cohort

Description:

Patients undergoing pelvic exenteration (PE) for colorectal cancer with involvement of the urinary bladder