Clinical trial NCT04970316: Late Organ Specific Adverse Effects hiPec or pElvic eXenteration
Official title: Organ Specific Late Adverse Effects, in Colorectal Cancer Patients Following Surgery With Either HIPEC or Pelvic Exenteration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: cytoreductive surgery
hyperthermic intraperitoneal chemotherapy
pelvic exenteration
adverse effects
bowel dysfunction
urinary dysfunction
sexual dysfunction
pain
lymphedema
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Karolinska University Hospital
name: Skane University Hospital
First posted: 2021-07-21
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators will prospectively include patients who have undergone surgery at Aarhus University Hospital, Karolinska University Hospital, Stockholm, and Skåne University Hospital, Malmö. Inclusion in Denmark will start February 2021 and in Sweden Summer 2021. Inclusion period is 15 months.

The HIPEC cohort will be established as a cross-sectional study. For newly operated patients, inclusion will happen shortly after surgery with prospective questionnaire follow-ups at 3, 6 and 12 months after inclusion. For patients who have undergone CRS+HIPEC more than 3 months ago, initial inclusion can take place at 6, 12, 18, 24, 36, 48 and 60 months after surgery.

Patients in the PE cohort will be included shortly after surgery with follow-up at 3 months, 6 months and 12 months after surgery.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Development of bowel related adverse effects after PE or CRS+HIPEC for colorectal cancer
timeFrame: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.
measure: Development of bowel related adverse effects after PE or CRS+HIPEC for colorectal cancer
timeFrame: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.
measure: Development of bowel related adverse effects after PE or CRS+HIPEC for colorectal cancer
timeFrame: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.
measure: Development of male urological dysfunction after PE or CRS+HIPEC for colorectal cancer
timeFrame: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.
measure: Development of female urological dysfunction after PE or CRS+HIPEC for colorectal cancer
timeFrame: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.
measure: Development of male sexual dysfunction after PE or CRS+HIPEC for colorectal cancer
timeFrame: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.
measure: Development of female sexual dysfunction after PE or CRS+HIPEC for colorectal cancer
timeFrame: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.
measure: Development of pain after PE or CRS+HIPEC for colorectal cancer
timeFrame: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.
measure: Development of lymphedema after PE for colorectal cancer
timeFrame: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery
measure: Development of stoma-related issues after PE or CRS+HIPEC for colorectal cancer
timeFrame: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects 3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.
Secondary outcomes:
measure: Risk factors associated with developing organ specific late adverse effects
timeFrame: PE cohort: Development and change in adverse effects 3, 6 and 12 months after surgery. HIPEC cohort: Development and change in adverse effects3, 6, 12, 18, 24, 36, 48 and 60 months after surgery.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Surgery, Aarhus University Hospital
city: Solna
country: Sweden
facility: Department of Surgery, Karolinska University Hospital
state: Stockholm
city: Malmö
country: Sweden
facility: Department of Surgery, Skånes University Hospital, Malmö
Study officials:
affiliation: Aarhus University Hospital
name: Rogini Balachandran, MD
role: PRINCIPAL_INVESTIGATOR
References: