title: Ultra-conservative fertility-sparing strategy for bilateral borderline ovarian tumours: an 11-year follow-up.
abstract: BACKGROUND
  This is a prospective long-term extension study of a randomized controlled trial aimed to assess the risk-benefit ratio of an ultra-conservative fertility-sparing approach in patients with bilateral borderline ovarian tumours (BOTs).
  
  
  METHODS
  The experimental group (n = 15) was treated with an ultra-conservative surgical approach consisting of bilateral cystectomy, whereas the control group (n = 17) received a less conservative surgery consisting of oophorectomy plus controlateral cystectomy alone. All patients received a complete laparoscopic staging followed by a fertility enhancement programme. Patients who completed childbearing were treated with a non-conservative standard treatment at the first recurrence.
  
  
  RESULTS
  After a follow-up period of 128 (9 interquartile range (IQR); 115-150 range) and 132 (7 IQR; 117-152 range) months for the experimental and control groups, respectively (P = 0.25), the time to first baby-in-arm (P < 0.02) and the relative rate (RR) of baby-in-arm (8.05 [95% confidence interval (CI), 1.20-9.66; P < 0.01]) were significantly lower and higher, respectively, for the experimental compared with the control group. Although the time to first recurrence was significently (P < 0.01) shorter for the experimental group, in the regression analysis the difference did not reach the statistic significance (P = 0.14), and the RR of recurrence (1.23 [95% CI, 0.62-3.17; P = 0.41]) was not significant. Finally the number needed to treat for pregnancy was three, the number needed to harm for radical surgery was only two.
  
  
  CONCLUSIONS
  The ultra-conservative fertility-sparing approach is more effective than the standard approach in terms of reproductive outcomes, but presents a higher oncological risk.
authors.affiliation: Department of Obstetrics and Gynaecology, University Magna Graecia of Catanzaro, Via T. Campanella 182/1- 88100, Viale Europa, 88100 Catanzaro, Italy. stefanopalomba@tin.it
authors.forename: Stefano
authors.initials: S
authors.lastname: Palomba
authors.forename: Angela
authors.initials: A
authors.lastname: Falbo
authors.forename: Serena
authors.initials: S
authors.lastname: Del Negro
authors.forename: Morena
authors.initials: M
authors.lastname: Rocca
authors.forename: Tiziana
authors.initials: T
authors.lastname: Russo
authors.forename: Francesco
authors.initials: F
authors.lastname: Cariati
authors.forename: Gianluca
authors.initials: G
authors.lastname: Annunziata
authors.forename: Achille
authors.initials: A
authors.lastname: Tolino
authors.forename: Pierosandro
authors.initials: P
authors.lastname: Tagliaferri
authors.forename: Fulvio
authors.initials: F
authors.lastname: Zullo
mesh_terms: D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D013509:Gynecologic Surgical Procedures / Q000379:methods; D006801:Humans; D010051:Ovarian Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D011247:Pregnancy; D018873:Pregnancy Rate; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D018570:Risk Assessment; D015996:Survival Rate; D013997:Time Factors