Clinical trial · Observational
Long Term Morbidity and Quality of Life in Retroperitoneal Sarcomas
Long Term Morbidity and Quality of Life After Multivisceral Resection for Primary Retroperitoneal Soft Tissue Sarcomas: a Prospective Observational Study
- 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)
No prospective data exist about long term morbidity and quality of life after multivisceral surgical resection for retroperitoneal soft tissue sarcoma (RSTS). In order to assess the safety of this surgical approach and the effect on the Quality of Life over the long period we propose a prospective observational study. The hypothesis is that the surgical treatment has no significant impact in determining a lower Quality of Life in the long term. Objectives Primary objective Estimate the difference between baseline and 4 and 12 months scores of the "global health status / QoL" scale in patients primarily treated for localized RSTS, as determined in QLQ-C30 version 3.0. Secondary objectives * Evaluate the long term morbidity of aggressive surgical approach to RSTS in terms of renal failure. * Evaluate the difference between baseline and 4 and 12 months scores of DN4 / LEFS / BPI questionnaires. * Evaluate the difference between baseline and 4 and 12 months scores of the following scales from QLC-C30: PF2, RF2, EF, CF, SF, FA, FI. * Evaluate the difference between baseline and 4 and 12 months scores of the following scales and single items from QLC-C29: Blood and mucus in stool, Stool frequency, Sexual interest, Impotence, Dyspareunia. * To correlate the surgical resection pattern (number and type of organs resected) and the tumor features (size, grading and histological subtype) with the long-term morbidity and quality of life. Eligibility Inclusion criteria * Adult patients (age \> 18 years) with primary localized RSTS surgically treated at our institution * Written, voluntary, informed consent Exclusion criteria \- Recurrent disease
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Morbidity | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Retroperitoneal Neoplasms | Retroperitoneal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Sarcoma, Soft Tissue | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Global Health Status
- timeFrame
- 4 and 12 months postoperatively
- description
- Change between baseline and 4 and 12 months scores of the "global health status / QoL" scale in patients primarily treated for localized RSTS, as determined in QLQ-C30 version 3.0.
Secondary outcomes (6)
- measure
- Renal failure
- timeFrame
- 12 months postoperatively
- description
- Evaluate the long term morbidity of aggressive surgical approach to RSTS in terms of renal failure.
- measure
- DN4 questionnaire for neuropathic pain
- timeFrame
- 4 and 12 months postoperatively
- description
- Change between baseline and 4 and 12 months scores
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients affected by primary retroperitoneal sarcoma and candidated to complete surgery (multivisceral resection) Exclusion Criteria: * Recurrent Disease
References
Publications (1)
- DERIVEDFiore M, Brunelli C, Miceli R, Manara M, Lenna S, Rampello NN, Callegaro D, Colombo C, Radaelli S, Pasquali S, Caraceni AT, Gronchi A. A Prospective Observational Study of Multivisceral Resection for Retroperitoneal Sarcoma: Clinical and Patient-Reported Outcomes 1 Year After Surgery. Ann Surg Oncol. 2021 Jul;28(7):3904-3916. doi: 10.1245/s10434-020-09307-7. Epub 2020 Nov 11. PMID 33175262