Evaluation of perioperative prophylaxis with fosfomycin tromethamine in ureteroscopic stone removal: an investigator-driven prospective, multicenter, randomized, controlled study.

PURPOSE: To compare efficacy, safety, and cost-effectiveness of fosfomycin tromethamine with other standard-of-care antibiotics in patients undergoing ureteroscopic lithotripsy. METHODS: This study was a prospective, multicenter, randomized, controlled trial. Eligible patients scheduled for ureteroscopic lithotripsy were randomly assigned to receive either fosfomycin (fosfomycin group, N = 101 patients) or standard-of-care antibiotic therapy as prophylaxis (control group, N = 115 patients). The incidence of infectious complications and adverse events was analyzed between the two groups, as well as the cost-benefit analysis. RESULTS: The incidence of infections following lithotripsy was 3.0% in the fosfomycin group and 6.1% in the control group (p > 0.05). Only asymptomatic bacteriuria was reported in fosfomycin group. In the control group was reported asymptomatic bacteriuria (3.5%), fever (0.9%), bacteremia (0.9%), and genitourinary infection (0.9%). The rate of adverse events was very low, with no adverse event reported in the fosfomycin group and only one in the control group (forearm phlebitis). The average cost per patient of antibiotic therapy with fosfomycin was 151.45 ± 8.62 yuan (22.7 ± 1.3 USD), significantly lower compared to the average cost per patient of antibiotics used in the control group 305.10 ± 245.95 yuan (45.7 ± 36.9 USD; p < 0.001). CONCLUSIONS: Two oral doses of 3 g fosfomycin tromethamine showed good efficacy and safety and low cost in perioperative prophylaxis of infections following ureteroscopic stone removal.

[Comparison outcomes of three surgical procedures in treatment of severe pelvic organ prolapse and analysis of risk factors for genital prolapse recurrence].

OBJECTIVE: To investigate clinical significance and application of modified pelvic floor reconstruction developed by Peking Union Medical College Hospital (MPFR) in treatment of severe pelvic organ prolapse (POP) by comparing the effectiveness, quality of postoperative sexual life, life satisfaction and risk factors for POP recurrence with the following two surgical procedures: traditional total vaginal hysterectomy with anterior-posterior colporrhaphy (TVH-APC) and total vaginal hysterectomy with lateral colporrhaphy and sacrospinous ligament fixation and vaginal bridge repair and episiotomy (TVH-LC-SSLF-VBR-EP). METHODS: Totally 173 patients with severe POP and at least two compartments defects of pelvic floor underwent surgeries in the study, 86 patients (group A) were treated by MPFR with polypropylene mesh application, 58 (group B) were treated by TVH-APC, and 29 patients (group C) were treated by TVH-LC-SSLF-VBR-EP. Peri-operative data and outcomes of postoperative courses at 6, 12, 18 months were collected and analyzed, in the meantime, the risk factors of recurrence were studied. RESULTS: (1) No statistical difference was observed among the above 3 groups in terms of length of operation, amount of blood loss, length of hospital stay, and morbidity after surgery (P > 0.05). (2) Cost hospitalization was (11 448 ± 3049) Yuan in group A, which was significantly higher than (7262 ± 1607) Yuan in group B and (7140 ± 1817) Yuan in group C (P < 0.05). (3) The length of vaginal cuff of (7.5 ± 1.4) cm in group A and (5.6 ± 1.1) cm in group C were significantly longer than (7.1 ± 0.6) cm in group B (P < 0.05). The width of vaginal cuff of (4.3 ± 0.3) cm in group A was larger than (3.4 ± 0.3) cm in group B and (3.3 ± 0.4) cm in group C (P < 0.05). (4) The recurrence rate at 12 months after surgery was 12.8% (11/86) in group A, which was similar with 17.2% (5/29) in group C (P > 0.05) and significantly less than 36.2% (21/58) in group B (P < 0.05). The rate of active sexual life of 16.3% (14/86) in group A was significantly higher than 1.7% (1/58) in group B and 0 in group C (P < 0.05). The index of life quality improvement at 12 months after surgery was 48 ± 12 in group A, which was no less than 53 ± 16 in group C (P > 0.05) and higher than 27 ± 9 in group B (P < 0.05). (5) Mesh rejection was observed in 6 patients in group A within 3 months after surgery, while the posterior vaginal wall was exclusively involved. No difference was found in urinary retention or urinary incontinence among three groups (P > 0.05). (6) The severe degree of POP, type of surgical procedure (TVT-APC), anterior compartment defect of pelvic floor, and early days of performing pelvic floor reconstruction surgeries were high risk factors for POP recurrence (P < 0.05). CONCLUSIONS: MPFR has a better curative effect and lower recurrence rate on patients with POP. It can help patients regain integrity of anatomical structure and functions of pelvic floor. TVH-LC-SSLF-VBR-EP is also effective.

Direct and indirect costs and long-term survival of laparoscopic anterior resection for rectal cancer.

BACKGROUND: Few studies evaluate the cost-effectiveness issues of laparoscopic anterior resection (LAR) for rectal cancer. This study evaluates direct and indirect costs of LAR and its long-term survival rate in rectal cancer patients. MATERIAL/METHODS: This prospective nonrandomized controlled trial included 2 endpoints (direct and indirect costs, and disease-free survival). From January 2003 to May 2005, rectal cancer patients admitted to our center were assigned to 2 groups: 87 patients underwent LAR (LAP), while 86 cases received open anterior resection (OPEN). The direct costs were prospectively evaluated. Main indirect cost is productivity loss. The data of direct costs, indirect costs, and the total costs were collected for the minimal cost analysis. RESULTS: Disease-free survival at 65 months in the LAP group and the OPEN group was 78.2% and 74.7%; there was no significant difference between the groups. Median direct costs were not significantly different between the LAP and the OPEN groups. Indirect costs of the LAP group were significantly lower than those of the OPEN group, while total costs were not significantly different. Cost percentage for operations, medications, and hospitalization were 75.90%, 11.28%, and 2.18% in the LAP group; while in the operation group, they were 54.50%, 29.09%, and 3.35%. CONCLUSIONS: Total economic budget for a patient receiving LAR was not significantly increased compared with the conservative method owing to its technical predominance, oncologic safety, as well as frequent bed turnover.