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Study will test frailty tools to choose ovarian cancer surgery patients

Recruiting · Sahar Salehi

What this means

Researchers plan to see if frailty tests can help pick which women should have surgery. They will also test early reversal of a temporary bowel opening and track quality of life.

Plain-English summary written by an AI model from the registry listing.

Status
Recruiting
Who can join
Ages 18 and over
Where
4 sites

Contacts and how to join ↗

The science

Registered title
Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer
Phase
Not applicable
Study type
interventional
Conditions
Ovarian Cancer
What is tested
Frailty and Quality of Life evaluation
Sponsor
Sahar Salehi
Ages
18 Years to no maximum
Dates
First posted Mar 7, 2024 · updated Sep 28, 2026

Registry summary

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.

Sites (4)

  • Karolinska University Hospital, Stockholm, Solna, Sweden
  • Sahlgrenska University Hospital and Sahlgrenska Academy, Gothenburg, Sweden
  • Linköping University Hospital, Linköping, Sweden
  • Skåne University Hospital, Lund, Sweden
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