Study characteristics | |||
Patient sampling | cross‐sectional study, enrolment not reported | ||
Patient characteristics and setting | Sample size: 15 patients Mean age: 54 years (range 37‐75) Presentation: Patients with primary ovarian cancer FIGO stageIIIC/IV suspected of peritoneal carcinomatosis and in whom preoperative evaluation was unsatisfactory to define the possibility of achieving a complete cytoreduction, no massive disease at diaphragm/xiphoid or liver pedicle, planned for PDS Diagnostics before index test: physical/gynaecological examination, CT abdomen/pelvis, Thorax x‐ray/CT, Kind of surgery: PDS 11; IDS 0 No debulking surgery 4 Setting: Department of gynaecology hospital Tenon, Paris, France |
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Index tests | Open diagnostic laparoscopy; examination of the whole abdomen, focus on involvement of small bowel, liver pedicle and upper right diaphragmatic dome. Cut‐off test‐positivity: having one or more of the criteria for unresectability Complications of index test: none |
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Target condition and reference standard(s) | Target condition: unresectable carcinomatosis Criteria for target condition: involvement of bowel mesentery/bulky disease diaphragm/massive involvement of liver pedicle Reference standard: Laparotomy. Test operators: not reported Percentage of patients in whom reference standard performed:73% Unresectable disease at laparotomy: 1 |
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Flow and timing | Time between reference standard and index test: 0 day. | ||
Comparative | |||
Notes | 15 patients underwent diagnostic laparoscopy, of these 11 were considered operable. Ten of the patients were indeed successfully operated and one had too extensive disease. The other four patients were treated with NACT. | ||
Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | Unclear | ||
Did the study avoid inappropriate exclusions? | Unclear | ||
Were the patients suspected of advanced ovarian cancer by conventional diagnostic work‐up? | Yes | ||
Were patients planned for primary cytoreductive surgery after conventional diagnostic work‐up? | Yes | ||
Low | |||
DOMAIN 2: Index Test Diagnostic open laparoscopy | |||
Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
If a threshold was used, was it pre‐specified? | Yes | ||
Were the same clinical data available when test results were interpreted as would be available when the test is used in practice? | Yes | ||
Did the study provide a clear definition of what was considered to be a "positive "result for the index test? | Yes | ||
Low | |||
DOMAIN 3: Reference Standard | |||
Is the reference standards likely to correctly classify the target condition? | Yes | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | No | ||
Low | |||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | Yes | ||
Were all patients included in the analysis? | Yes | ||
Did patients receive the same reference standard regardless of the index test result? | No | ||