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. 2017 Jul 25;2017(7):CD002912. doi: 10.1002/14651858.CD002912.pub7

Fatthy 2001.

Methods RCT. Random number tables. Statistician did not allow surgeon or patients to know the next allocation
 Blinding not mentioned
 No power calculation
 Not ITT analysis
 Follow‐up 4 months to 18 months
Participants N = 74
 One patient lost to follow‐up
UDS ‐ confirmed SUI
Combined primary and recurrent
Includes women with prolapse
Mean age in lap group 40.29 years (range 30‐55)
 Open group 42.9 years (range 30‐65)
 74% menopausal, 35% previous pelvic operations
Inclusion: not mentioned
 Exclusion: detrusor instability, underactive detrusor, intrinsic sphincter deficiency, limited vaginal mobility, stages III and IV vaginal prolapse, or contradictions to laparoscopy and surgery in general
 Baseline comparison of groups similar in age, weight, parity, menopausal status, pelvic relaxation, previous surgery, pre‐operative urodynamics
Single centre, university‐based, department of Ob & Gyn.
 Cairo, Egypt
Interventions I: Burch (40)
 II: Laparascopic Burch colposuspension (34)
 Similar technique used for both groups; one anchoring suture per side.
Outcomes Number cured
 UDS parameters
 Length of stay; complications; operating time; wound infection; blood loss; haematoma; spontaneous voiding; analgesia frequency; detrusor instability; post op pain; pelvic relaxation, dyspareunia
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk random numbers table
Allocation concealment (selection bias) Low risk "statistician did not allow patients and surgeon to know the next allocation"
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk not mentioned
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk not mentioned
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk not mentioned
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk one patient lost to follow up
Other bias Unclear risk no other bias identified