Colorectal cancer
Conditions
Interventions
This study evaluates the effect of an existing procedure implemented in the local CRC pathway as follows: prophylactic salpingo-oophorectomy versus standard care in a female population with colorectal
Sponsors
Rudi Roumen
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female gender 2. Age =60 years at the time of CRC diagnosis 3. Intended curative resection of colon or rectal cancer, with no evidence of incurable distant metastases 4. informed consent or consent by opt-in form
Exclusion criteria
Exclusion criteria: 1. No signed informed consent and no consent by opt-in form 2. surgery with palliative intent 3. Known distant metastases preoperatively, or evidence of distant or intraperitoneal metastases during operation, except when curative metastasectomy is considered possible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main aim of this study is to determine whether prophylactic bilateral salpingo-oophorectomy conducted in postmenopausal patients aged =60 years during surgery for primary CRC reduces the incidence of ovarian malignancies (metastatic or primary) during a three-year follow-up period. Moreover, this study will provide the data necessary to calculate the number needed to treat (NNT) in order to prevent one case of ovarian cancer (metastatic or primary). | — |
Secondary
| Measure | Time frame |
|---|---|
| What is the effect of PSO on disease-free survival (DFS) after 3-years of follow-up? What is the concomitant NNT to gain one year of DFS. What is the effect of PSO on surgery-related morbidity? In the non-PSO group, what is the incidence and pattern of intra-abdominal relapse, including CRC ovarian metastases and primary ovarian cancer, requiring renewed surgical intervention? During primary surgery, how often are abnormal ovaries found that require resection? What is the incidence of (micro)metastatic disease in the ovaries of patients with primary CRC? What is the effect of PSO on quality of life as assessed using health-related quality of life (HRQL) questionnaires, and on long-term effects such as surgery for abdominal adhesions occurring within 3 years? What is the effect of PSO on 3-year survival? What is the percentage of patients who have a preference for PSO (or no PSO) when scheduled for surgery for primary CRC? Within 3 years of their index surgery, how many patients revise their initial decision of no PSO and subsequently undergo PSO? Are there differences in the baseline characteristics between patients who choose PSO compared to those who do not? The baseline patient characteristics include age, ASA-classification, BMI, previous unilateral oophorectomy, comorbidities, and neo-adjuvant therapy. | — |
Contacts
Public ContactRichard van der Meer
Máxima Medisch Centrum Eindhoven/Veldhoven
Outcome results
None listed