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).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.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.The ultra-conservative fertility-sparing approach is more effective than the standard approach in terms of reproductive outcomes, but presents a higher oncological risk.

Ultra-conservative fertility-sparing strategy for bilateral borderline ovarian tumours: an 11-year follow-up / Palomba, Stefano; Falbo, Angela; Del Negro, Serena; Rocca, Morena; Russo, Tiziana; Cariati, Francesco; Annunziata, Gianluca; Tolino, Achille; Tagliaferri, Pierosandro; Zullo, Fulvio. - In: HUMAN REPRODUCTION. - ISSN 0268-1161. - 25:8(2010), pp. 1966-1972. [10.1093/humrep/deq159]

Ultra-conservative fertility-sparing strategy for bilateral borderline ovarian tumours: an 11-year follow-up

Palomba, Stefano;
2010

Abstract

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).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.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.The ultra-conservative fertility-sparing approach is more effective than the standard approach in terms of reproductive outcomes, but presents a higher oncological risk.
2010
BOTs; fertility-sparing strategy; pregnancy; recurrence; ultra-conservative surgery
01 Pubblicazione su rivista::01a Articolo in rivista
Ultra-conservative fertility-sparing strategy for bilateral borderline ovarian tumours: an 11-year follow-up / Palomba, Stefano; Falbo, Angela; Del Negro, Serena; Rocca, Morena; Russo, Tiziana; Cariati, Francesco; Annunziata, Gianluca; Tolino, Achille; Tagliaferri, Pierosandro; Zullo, Fulvio. - In: HUMAN REPRODUCTION. - ISSN 0268-1161. - 25:8(2010), pp. 1966-1972. [10.1093/humrep/deq159]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1664153
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