Tests frailty checks and quality of life in women with ovarian cancer surgery
Studies whether frailty checks help choose surgery for women with ovarian cancer.
Plain-language title generated from the registry record
Registry title: Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer
Key facts
- Where
- Gothenburg, Linköping, Lund, and Stockholm, SwedenSee the 4 sites
Where in Sweden
- Sahlgrenska University Hospital and Sahlgrenska AcademyGothenburg, SwedenTaking people
- Linkoping University HospitalLinköping, SwedenTaking people
- Skåne University HospitalLund, SwedenTaking people
- Karolinska University HospitalStockholm, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sahar Salehi
- Trial code
- NCT06298877
- Record updated
- 28 September 2026
- Original description
Complete macroscopic surgical resection (CMR) requires extensive surgery and combined with chemotherapy confers best chance of survival in advanced ovarian cancer. During cytoreductive surgery 11% of women require a temporary diverting intestinal stoma.Read full original descriptionShow less
Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer (FOLERO) : A Prospective Cohort Study to Determine the Effect of Frailty on Survival and to Assess Early Reversal of Temporary Intestinal Stoma
Complete macroscopic surgical resection (CMR) requires extensive surgery and combined with chemotherapy confers best chance of survival in advanced ovarian cancer. During cytoreductive surgery 11% of women require a temporary diverting intestinal stoma.
Unexpectedly, our results from a unique fully accounted for population demonstrate that survival was not improved when increasing the proportion of women in whom CMR was achieved and in a yet unidentified subgroup of women extensive surgery was detrimental. In these women surgical treatment should be omitted in favor of chemotherapy only. Accordingly, there is an imperative need to improve patient selection to surgical treatment.
In Sweden, we treat an unselected population of women in a public healthcare system, where 30% of women with are >75 years. Despite these circumstances guidelines on patient-selection are lacking.
Age is an imprecise variable to base clinical decisions on but must be considered with an aging population. The dynamics between physiological changes of aging, comorbidity and medical condition are included in the concept of frailty, that has gained little attention in oncology, despite their potential to stratify risk and mortality.
The FOLERO study is a prospective adequately powered national cohort study with aim to determine if frailty instruments may be used to select patient to surgical treatment. In addition, we test the feasibility of early stoma reversal after index cytoreductive surgery in a small phase I trial and follow our patients Health Related Quality of Life after state of the art surgical treatment.
Inclusion: Women with epithelial ovarian cancer scheduled for cytoreductive surgery with curative intent; Age ≥18 years; Signed written informed consent.
Exclusion: Other diagnosis than ovarian cancer on final pathology; Not able to understand the Swedish or English language.