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

Impact of oophorectomy at cystectomy for urinary bladder cancer on female hormonal status and sexual function: Randomized study on Oophorectomy at Cystectomy (ROC study)

Registry ID

ISRCTN18217210

Source registry

ISRCTN

Status

Recruiting

Study type

INTERVENTIONAL

Sponsor

Lund University

Enrollment

360

Start date

2017-04-18

Completion date

2028-12-31

Last update

2026-08-17

Conditions

• Malignant neoplasm of bladder
• Cancer

Summary

Bladder cancer treated with radical cystectomy

Detailed description

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.

Interventions

• OTHER: 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.

Inclusion criteria

1. Women undergoing radical cystectomy 2. Aged 18-85 years

Exclusion criteria

1. Clinical suspicion of tumour involvement of either ovaries 2. Previous radiation of the pelvis 3. Previous cystectomy 4. Previous oophorectomy

Locations

• , , Sweden

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