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. 2014 Feb 21;2014(2):CD009786. doi: 10.1002/14651858.CD009786.pub2

Brun 2009

Study characteristics
Patient sampling Retrospective study
Patient characteristics and setting Sample size: 55 patients Mean age: 62 years (range 21‐88) Presentation: Patients with primary ovarian cancer FIGO stage III/IV, no contraindication for surgery or malnutrition, evaluation for PDS
Diagnostics before index test: physical/gynaecological examination, CA 125, CT abdomen/pelvis, Thorax x‐ray/CT, routine blood test
Kind of surgery: PDS 26; IDS 26: No debulking surgery 3
Setting: Department of gynaecology hospital Tenon, Paris, France.
Index tests Open diagnostic laparoscopy performed by 7 surgeons, 3 gynaecological oncologists, 4 non‐gynaecological surgeons. Frozen section of tumour/metastasis. In case of operability direct cytoreduction by laparotomy
Cut‐off test‐positivity: absence of visible residual tumour was considered feasible
Complications of index test: 1 trocar metastasis occurred in PDS group (2%)
Target condition and reference standard(s) Target condition: macroscopic residual tumour.
Criteria for target condition: extensive peritoneal carcinomatosis/involvement of bowel mesentery/bulky disease diaphragm/unresectable upper abdomen metastases.
Reference standard: Laparotomy.
Test operators: gynaecological oncologists and general gynaecologists.
Percentage of patients in whom reference standard performed: 47%
Unresectable disease at laparotomy: 12
Flow and timing Time between reference standard and Index test: 0 day
Comparative  
Notes Same population as Brun 2008. 52 patients had a diagnostic laparoscopy. 26 of these patients were considered suitable for laparotomy. However 8 had more than 1 cm of residual disease left after laparotomy. The other 26 patients received NACT and interval debulking surgery. Cytoreduction only when absence of visible residual tumour was considered feasible.
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? Unclear
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? Unclear
Did patients receive the same reference standard regardless of the index test result? No