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Table 1 Primary and secondary outcomes of the study

From: Role Of Ovarian Metastases In Colorectal Cancer (ROMIC): a Dutch study protocol to evaluate the effect of prophylactic salpingo-oophorectomy in postmenopausal women

Outcome

Metric

Time point/period

Primary

 Occurrence of ovarian cancer (primary or metastatic)

Incidence

36 months

 Number needed to treat to prevent one case of ovarian cancer (primary or metastatic)

NNT

36 months

Secondary

 Disease-free survival

DFS

36 months

 Number needed to treat with PSO to prevent one case of ovarian cancer (primary or metastatic)

NNT

36 months

 Surgery-related morbidity of PSO

Number

36 months

 Subsequent intra-abdominal relapse pattern in the non-PSO group

Number

36 months

 Abnormal ovaries found during surgery

Number

During surgery

 Incidence of ovarian (micro)metastatic disease

Incidence

36 months

 Quality of life (EORT QLQ-C30 and EORTC QLQ-CR29)

SUM score

Baseline, 3-, 12-, 24- and 36 months

 Repeat surgery for complications (i.e. adhesions)

Numbers

36 months

 Long-term overall survival

OS in days

60 months

 Preference for PSO

Numbers

36 months

 Reversal of decision

Numbers

36 months

 Baseline characteristics

Numbers

Before surgery

Other parameters

 Type of surgery

Number per type of surgery

During surgery

 Operation duration

Minutes

During surgery

 Blood loss

Milliliters

During surgery

 Pre- and postoperative treatment strategies

Number per type of treatment strategy

Before surgery and 36 months

  1. NNT Number needed to treat, DFS Disease free survival, SUM Single Usability Metric, OS Overall survival, PSO Prophylactic salpingo-oophorectomy, EORT QLQ European Organization for Research and Treatment of Cancer European Union Quality of Life Questionnaire