Clinical trial · Observational
Psychological distREsS hipEc oR pelVic Exenteration
Psychological Distress in Colorectal Cancer Patients Following Surgery With Either HIPEC or Pelvic Exenteration
NCT04956107CI-TRIAL-00064308PRESERVEunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to describe type and extent of psychological distress (adverse effects) in patients undergoing surgery for colorectal cancer with peritoneal metastases and after surgery for colorectal cancer with involvement of the urinary bladder.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colo-rectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- HIPEC cohort
- description
- Patients undergoing cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for colorectal cancer with peritoneal metastases
- label
- PE cohort
- description
- Patients undergoing pelvic exenteration (PE) for colorectal cancer with involvement of the urinary bladder
Primary outcomes (6)
- measure
- Development of depression 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
- description
- Descriptive analysis will be done using the following questionnaire: PHQ-9 (patient health questionnaire)
- measure
- Development of anxiety after PE or CRS+HIPEC for colorectal cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBalachandran R, Thaysen HV, Christensen P, Zachariae R, Iversen LH. Biopsychosocial Late Effects After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Metastases from Colorectal and Appendiceal Cancer: A National Prospective Cohort Study. Ann Surg Oncol. 2024 Mar;31(3):1959-1969. doi: 10.1245/s10434-023-14618-6. Epub 2023 Dec 21. PMID 38127212