Short summary

Palliative pelvic exenteration (PPE) is performed to relieve symptoms in patients with locally advanced or recurrent pelvic cancer. This study assesses patient satisfaction, quality of life (QoL), and cost-effectiveness of PPE. Forty patients will be recruited nationally and internationally. Data on clinical outcomes, PROMs, and costs will be collected. Findings will optimize patient selection and decision-making, improving palliative cancer care.

Rationale

Patients with locally advanced or recurrent cancer of various origins invading surrounding organs or structures in the pelvis can, in many cases, be offered curative treatment, including pelvic exenteration (PE). This operation constitutes an en bloc removal of the pelvic organs - either via anterior, posterior, or total exenteration and may include resection of the pelvic sidewalls with the need for perineal and vascular reconstruction. The goal is to achieve oncological radicality with tumor-free (R0) margins. Although short-term mortality is low (0.5-2%), the 30-day morbidity remains high (27-45%), particularly in primary advanced or recurrent rectal and gynecological malignancies, where factors such as high comorbidity, obesity, and complex reconstruction requirements increase the risk of complications. In palliative cases, where symptom relief is the primary objective - often in patients with incurable metastases or where an R0 resection is unlikely - palliative pelvic exenteration (PPE) may be considered. Previous studies have shown varying results regarding symptom relief and quality of life after PPE, and the evidence remains limited. Therefore, it is essential to assess resectability via imaging, systematically address the expected symptom relief, and involve the patient in a shared decision-making process. There is limited evidence regarding postoperative QoL in patients undergoing PPE. In particular, the relationship between the various symptoms that serve as indications for surgery and their association with potential improvements in QoL requires further clarification. Future research with systematic documentation of postoperative complications and the use of patient reported outcome measures (PROM) is needed to clarify the role of PPE and optimize patient selection for this procedure.

Description of the cohort

40 patients with locally advanced or recurrent pelvic cancer of any disease entity, who are deemed eligible for PPE to alleviate symptoms, will be included. Patients will be recruited nationally in Denmark through the ACROBATIC network, a national network for research in cancer surgery. Patients will, furthermore, be recruited internationally through the Pelvex Collaborative which is an international collaborative for centers performing pelvic exenteration procedures for locally advanced and recurrent pelvic cancer. The collaborative includes more than 100 international centers from 35 countries.

Data and biological material

In this study, clinical data will be collected from patient records and perioperative documentation. This includes patient demographics, medical history, tumor characteristics, treatment details, operative parameters, and postoperative outcomes. In addition, patient-reported outcome measures (PROMs) will be gathered using validated questionnaires-such as the EORTC QLQ-C30 and disease-specific instruments-administered preoperatively and at 3, 6, and 12 months postoperatively to assess QoL and symptom relief. Economic data related to healthcare costs will also be collected for subsequent cost-utility analyses. All data will be securely stored in an encrypted REDCap database.

Collaborating researchers and departments

Department of Surgery, Aarhus University Hospital

• Anne Bodilsen, Attending physician

Department of Gastroenterology, Herlev Hospital

• Kirsten Hougaard, Consultant surgeon,