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 |
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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 |