Fayallah 2011.
Methods | Single‐centre RCT randomly assigning participants from a university hospital in Egypt | |
Participants | 38 women with histologically proven endometrial carcinoma thought to be International Federation of Gynecology and Obstetrics stage I Women recruited between April 2005 and October 2008 were randomly assigned preoperatively to undergo extra fascial hysterectomy, bilateral salpingo‐oophorectomy with pelvic lymphadenectomy (iliac and obturator lymph nodes) (n = 21) or extrafascial hysterectomy and bilateral salpingo‐oophorectomy alone (n = 17). Before surgery, immunohistochemistry was carried out on endometrial tissue for detection of P53 overexpression. A total of 30 (79%) women had FIGO surgical stage I disease, four (11%) had stage II and four (11%) stage III disease. Depth of invasion was as follows: endometrium only 6 (16%); inner half of myometrium 17 (45%); and outer half of myometrium or further 15 (39%). Histological cell types were as follows: endometrioid 29 (80%); adenocarcinoma NOS 4 (11%); and papillary serous 5 (13%). Tumour grade was as follows: 14 (37%) had tumour grade 1; 16 (42%) grade 2; and 8 (21%) grade 3 No significant difference was noted between arms in terms of age, medical status, surgical stage, histological type, or grade of tumour. The number of nodes removed from participants in either arm was not reported, although the overall number of nodes removed on each pelvic side was reported as ranging from 6 to 14 After surgery, adjuvant radiotherapy was provided at the discretion of tumour board members. Women were followed up every 3 months with clinical assessment and ultrasound and underwent an MRI every 6 months |
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Interventions |
Intervention Extrafascial hysterectomy with bilateral salpingo‐oophorectomy combined with pelvic lymphadenectomy involving common iliac, external iliac and obturator lymph node dissection Comparison Extrafascial hysterectomy with bilateral salpingo‐oophorectomy alone |
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Outcomes | Overall survival Recurrence rate |
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Notes | Mean duration of follow‐up was 21.5 months (range 6 to 40) Outcomes of overall survival and recurrence rate were based on the number of participants known to have died or in whom the disease was known to have progressed, rather than knowledge of survival and recurrence status among study participants |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | Mean follow‐up duration from treatment was 21.5 months (range 6 to 40 months); no other information regarding attrition was given |