Randomized comparison of oophorectomy or not in conjunction with radical cystectomy in women

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2017
INTERVENTION: Patients undergoing radical cystectomy will be randomized using closed envelopes to undergo either: 1. No oophorectomy 2. Excision of one ovary 3. Excision of both ovaries Oophorectomy will be performed by standard surgical methods, including ligation of parametrium with Ligasure when preserving the one or two ovaries. Follow‐up will be 12 months postoperatively according to the protocol, however clinical follow‐up will be according to clinical routines. CONDITION: Bladder cancer treated with radical cystectomy ; Cancer ; Malignant neoplasm of bladder PRIMARY OUTCOME: 1. Sexual function, measured using Female Sexual Function Index (FSFI) score at baseline, 12 and 52 weeks postoperatively ; 2. Hormonal status, measured using plasma levels of total testosterone, dihydrotestosterone, SHBG, anti‐müllerian‐hormone, androstenedione, dehydroepiandrosterone sulphate, progesterone, oestradiol (sensitive method for postmenopausal women), LH and FSH, at baseline, 12 and 52 weeks postoperatively SECONDARY OUTCOME: No secondary outcome measures INCLUSION CRITERIA: 1. Women undergoing radical cystectomy 2. Aged 18‐85 years
Epistemonikos ID: 82b55e9071d8de9dfabca45b7d829c31c2d3ec36
First added on: Aug 23, 2024