Late Organ Specific Adverse Effects hiPec or pElvic eXenteration
NCT ID: NCT04970316
Last Updated: 2023-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
225 participants
OBSERVATIONAL
2021-01-25
2023-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HIPEC cohort
Patients undergoing cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer with peritoneal metastases
No interventions assigned to this group
PE cohort
Patients undergoing pelvic exenteration (PE) for colorectal cancer with involvement of the urinary bladder
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Skane University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Rogini Balachandran, MD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Department of Surgery, Aarhus University Hospital
Aarhus, , Denmark
Department of Surgery, Karolinska University Hospital
Solna, Stockholm County, Sweden
Department of Surgery, Skånes University Hospital, Malmö
Malmo, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Per Nilssons, Ass. Professor
Role: primary
Marie-Louise Lydrup, Ass. Professor
Role: primary
Other Identifiers
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LOSAPEX
Identifier Type: -
Identifier Source: org_study_id
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