Table 1 Study characteristics
From: Laparoscopic versus robotic-assisted sacrocolpopexy for pelvic organ prolapse: a systematic review
Study | Paraiso 2011 | Anger 2014 |
|---|---|---|
Design | Parallel-group, single-center trial RCT | Two-center, parallel-group RCT |
Ethical approval | Yes | Yes |
Power calculation | Yes—to detect a 50-min difference in operating time with 90 % power and 5 % type 1 error | Yes—to detect at least US$2500 difference in total charges with 95 % power and 5 % type 1 error |
CONSORT statement | Yes | No |
Conflict of interest | No conflicts of interest | No conflicts of interest |
Participants | Country: USA Setting: Cleveland Clinic Population: women >21 years presenting with posthysterectomy vaginal apex prolapse with POP-Q stage 2–4 desiring surgical management between January 2007 to December 2009 Patients were excluded if not candidates for general anesthesia, underwent a prior sacral colpopexy or rectopexy, had a history of PID, had a BMI >40 kg/m2 | Country: USA Setting: University of California-Los Angeles/Cedars-Sinai and Loyola University Medical Centers Population: women with symptomatic pelvic organ prolapse stage II or greater and clinical indication for sacrocolpopexy Patients were excluded if future childbearing, pregnant or pregnancy in the last 12 months, unable to read, write, and comprehend English |
Interventions | Sacrocolpopexy using 2 separate 4 × 15 cm pieces of polypropylene mesh. Use of 4 ports for the laparoscopy, 5 for the robotic-assisted laparoscopy in W formation | Sacrocolpopexy with 2 separate pieces of polypropylene mesh and Gore-Tex sutures—surgeon’s preference determined brand of the mesh and closure of the retroperitoneal lining |
Randomization method | Computer-generated randomization schedule—stratified by surgeon | Computer-based block randomization based on site and need for concurrent hysterectomy randomization on the day of the surgery |
Allocation concealment | Use of opaque envelopes | Treatment allocation is uploaded on a password protected website—randomization assignment is revealed to treating surgeon on the day of surgery Under procedure in patient file: laparoscopic sacrocolpopexy per the ACCESS protocol |
Blinding | Blinding of research staff and patients | Blinding of patients and research staff for 6Â weeks after surgery |
Groups comparable | Yes | Yes |
Intention-to-treat analysis | Yes | Yes |
Follow-up | Up to 1Â year | Up to 1Â year |
Loss to follow-up | 4 lost to FU after surgery from LASC 2 from RASC | 3/78 before 6Â M FU visit |
Intervention group | Robotic-assisted sacrocolpopexy (randomized: n = 40—underwent surgery n = 35) | RASC (n = 40) |
Control group | Laparoscopic sacrocolpopexy (randomized: n = 38—underwent surgery: n = 33) | LASC (n = 38) |
Concomitant surgery | Yes | Yes |
Surgical experience | At least 10 robotic procedures | At least 10 procedures of each type |
Outcome measures | Primary outcome: operating time Secondary outcomes: postoperative pain, use of NSAIDs, complications, costs, postoperative subjective and objective cure rate | Primary outcome: costs Secondary outcomes: surgical outcomes (blood loss and postoperative pain), POP-Q, symptom severity and QoL, adverse events |