Fagotti 2004

Study characteristics
Patient sampling	Prospective study
Patient characteristics and setting	Sample size: 64 patients Mean age: 57.4 years (+/‐ 12,7) Presentation: Patients undergoing surgery for a suspected advanced ovarian or peritoneal cancer, exclusion advanced ASA or very large mass reaching xiphoid/occupying the abdominal wall or cavity. Included also if on radiologic and clinical criteria suspected of unresectable disease. Diagnostics before index test: physical/gynaecological examination, ultrasonography, CA 125, CT abdomen/pelvis, Thorax x‐ray/CT Kind of surgery: All patients received explorative laparotomy. Performed before: PDS 42; IDS 19: recurrence: 3
Index tests	Open diagnostic laparoscopy, investigating frozen pelvis, omental cake, diaphragmatic or peritoneal extensive carcinomatosis, tumour diffusion to the large and small curvature of the stomach, large and/or small bowel mesentery disease, spleen and/or liver metastases, bulky lymph nodes. Cut‐off test‐positivity: absence of criteria for un resectability Complications of index test: none
Target condition and reference standard(s)	Target condition: resectability of tumour residual of less than 1 cm not possible Criteria for target condition: extensive peritoneal carcinomatosis/involvement of bowel mesentery/bulky disease diaphragm/ portal triad disease/unresectable upper abdominal metastasis Reference standard: Explorative laparotomy. Test operators: not reported percentage of patients Reference stand performed: 100% Unresectable disease at laparotomy: 23
Flow and timing	Time between reference standard and index test: 0 day.
Comparative
Notes	Not only patients planned for primary surgery, but also planned for IDS or secondary surgery because of recurrence. After inclusion and laparotomy FIGO I‐II, III‐IV 9‐42 respectivily, 6 benign, 7 other tumour
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	Yes
Did the study avoid inappropriate exclusions?	Yes
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?	No
			High
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?	No
Did patients receive the same reference standard regardless of the index test result?	Yes