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Role of predictive markers for severe postoperative complications in gynecological cancer surgery: a prospective study (RISC-Gyn Trial)
  1. Melisa Guelhan Inci1,2,
  2. Rolf Richter1,
  3. Hannah Woopen1,
  4. Julia Rasch1,
  5. Kathrin Heise3,
  6. Louise Anders1,
  7. Kristina Mueller1,
  8. Sara Nasser1,
  9. Timo Siepmann2,4 and
  10. Jalid Sehouli1
  1. 1 Department of Gynecology with Center for Oncological Surgery, European Competence Center for Ovarian Cancer, Charite Universitatsmedizin Berlin, Berlin, Germany
  2. 2 Division of Healthcare Sciences, Center for Clinical Research and Management Education, Dresden International University, Dresden, Germany
  3. 3 Gynecology, Vivantes Auguste Viktoria Hospitals, Berlin, Germany
  4. 4 Neurologie, Universitätsklinikum Carl Gustav Carus, Dresden, Germany
  1. Correspondence to Dr Melisa Guelhan Inci, Department of Gynecology with Center for Oncological Surgery, Charite Universitatsmedizin Berlin, Berlin, Germany; guelhan.inci{at}


Background Surgery for gynecological cancer involves highly invasive and complex procedures potentially associated with various complications, which can cause extended hospital stays and delay of subsequent therapy, with a detrimental effect on the prognosis. The aim of this study was to explore and define the predictors of severe postoperative complications in patients undergoing surgery for gynecologic cancer.

Methods Patients undergoing surgery for gynecologic cancers were analyzed prospectively from October 2015 through January 2017. Using validated assessment tools preoperatively, we assessed comorbidities, performance status, quality of life, nutritional and body composition by bioelectrical impedance analysis, and the surgical data of each patient. Surgical complications were graded using the Clavien-Dindo criteria. Using stepwise logistic regression models, we identified predictive markers for postoperative complications.

Results Of the 226 enrolled patients, 40 (17.7%) experienced a grade ≥IIIb complication according to the Clavien-Dindo criteria. In the regression analysis, overweight/obesity (body mass index >25) (OR 6.41, 95% CI 2.38 to 17.24; p<0.001) and impaired physical functioning defined by a quality of life questionnaire (OR 4.19, 95% CI 1.84 to 9.50; p=0.001) emerged as significant predictors of postoperative complications. Moreover, postoperative complications were predicted by phase angle of bioelectrical impedance analysis <4.75° (OR 3.11, 95% CI 1.35 to 7.16; p=0.008) and Eastern Cooperative Oncology Group (ECOG) performance status >1 (OR 2.51, 95% CI 1.06 to 5.92; p=0.04). Intraoperative factors associated with higher risk of postoperative complications were increased use of norepinephrine (>11 µg/kg/min) (OR 5.59, 95% CI 2.16 to 14.44; p<0.001) and performance of large bowel resection (OR 4.28, 95% CI 1.67 to 10.97; p=0.002).

Conclusion In patients undergoing surgery for gynecological cancer, preoperative evaluation of performance status according to ECOG, domains of quality of life and nutritional status, as well as intraoperative monitoring of risk factors, might help to identify patients at high risk for severe postoperative complications, and thus reduce surgical morbidity and mortality.

  • gynecologic surgical procedures
  • ovarian cancer
  • postoperative complications
  • quality of life (PRO)/palliative care
  • surgical procedures
  • operative

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  • Contributors MGI: Study conception, literature review, data Collection, data analysis and interpretation, writing of the manuscript. RR: Statistical analysis. HW: Manuscript review and editing. JR: Data collection, manuscript review. KH: Data collection, manuscript review. LA: Data collection, manuscript review. KM: Data collection, manuscript review. SN: Manuscript review and editing. TS: Manuscript review and editing. JS: Study conception, data review and analysis, manuscript review and editing.

  • Funding This study was funded by the ALLIMOGI- Foundation.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary material.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.