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Late Organ Specific Adverse Effects hiPec or pElvic eXenteration (NCT04970316) | Clinical Trial Compass

UnknownNot Applicable

Late Organ Specific Adverse Effects hiPec or pElvic eXenteration

Denmark, Sweden225 participantsStarted 2021-01-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

1

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.

2

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.

3

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.

4

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.

5

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.

6

Trial details

NCT IDNCT04970316

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-01

Contact for this trial

Rogini Balachandran, MD

+4542400620 rogbal@rm.dk

View on ClinicalTrials.gov More Colorectal Cancer trials