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【Objective:】 To analyze and explore the key points of the ethical review of real-world research in pediatric population, and to provide reference for ethical review of real-world research in pediatric population. 【Methods:】 According to the characteristics of real-world research and pediatric clinical trials, the review points of real-world research in pediatric population were analyzed and discussed in comparison with the principles and focus of ethical review in general clinical research. 【Results:】 The ethics committee should pay particular attention to the review of informed consent, privacy protection, risk benefit assessment, cost and compensation, and should also take into account the research design, data governance, research conflicts of interest, research registration and publication, etc., and conduct scientific and reasonable ethical review of real-world research in pediatric population. 【Conclusion:】 Clinical trials in pediatric population should have stricter and scientific ethical review, which can not only protect the interests of vulnerable groups of minors, but also standardize real-world research in pediatric population and promote the healthy development of pediatric clinical research, so as to better protect children and promote their health.
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Objective To evaluate the efficacy of modified abdominal laparoscopy in the repair of complex vesical vaginal fistula after total hysterectomy.Methods The clinical data of 58 cases of urinary bladder and vagina fistula in our hospital from April 2014 to December 2017 were retrospectively analyzed,of which 32 cases were repaired by ordinary abdominal laparoscopy from April 2014 to February 2016 and 26 cases were repaired by modified abdominal laparoscopy from March 2016 to June 2017.On the basis of the original laparoscopy,the modified transabdominal laparoscopy enlarged the free range between the vaginal stump and the bladder,separated the anterior vaginal wall from the bladder completely and dissociated the retrovaginal peritoneum,wrapping around the vaginal stump to make the peritoneum.The median age of ordinary group was 52 (range:33-67)years old,the median course of disease was 12 (range:3-40) months,and the size of fistula was (25.5 ± 10.3) mm.The median age of modified group was 50 (range:37-65) years,the median course of disease was 11.5 (range:3-36) months,and the size of the fistula was (26.3 ± 9.1) mm.The operation time,bleeding volume,the time of hospitalization,the rate of complications and the success rate of the operation were compared.Results The operation time of the two groups was successfully completed.The operation time of the modified group [(164.2 ± 21.2) min] was significantly shorter than that of the common group [(201.4 ± 25.8) min],and the difference was statistically significant (P ＜ 0.01).In the modified group,the cure rate (100.0％,26/26) was higher than that in the normal group (84.4％,27/32,P ＜ 0.05).There was no significant difference in the amount of intraoperative bleeding[50 (10-100) ml vs.55 (5-110) ml],hospitalization time [(9.1 ± 1.7) d vs.(10.0 ± 1.8) d],postoperative infection [19.2％ (5/26) vs.15.6％ (5/32)],urinary incontinence [7.7％ (2/26) vs.9.4％ (3/32)],urinary frequency [15.4％ (4/26) vs.21.9％ (7/32)],intestinal obstruction [3.8％ (1/26) vs.9.4％ (3/32)] between the modified group and common group (P ＞ 0.05).Conclusions The modified transabdominal laparoscopic mode shortens the operation time,and improves the cure rate of the operation.Satisfactory results are recommended for the repair of high complex bladder vagina fistula.
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Objective To evaluate the safety,feasibility of the application of "four-quadrant" tumor target-artery positioning in "zero-ischemia" retroperitoneal laparoscopic partial nephrectomy.Methods A retrospective study was conducted on 25 patients who underwent retroperitoneal laparoscopic partial nephrectomy from November 2016 to March 2017 by single surgeon.There were 15 males and 10 females with a mean age of (52.6 ± 11.9) years old.The mean diameter of the tumor was (3.8 ± 0.5) cm.The mean R.E.N.A.L.score was (9.0±1.3).The mean GFR of the operation side was (49.2±11.4) ml/(min · 1.73 m2) before the operation.All 25 patients underwent 3 Dimentional CT for the reconstruction of their renal models.The tumor target-artery was located in "four-quadrant" system,which based on the boundary between tumor and renal parenchyma.Perioperative outcomes including the estimated blood loss (EBL),operation time,complications and oncological outcomes were carefully collected and analyzed.Results Of all the 25 patients,21 patients underwent "zero-ischemia" retroperitoneal laparoscopic partial nephrectomy,the mean operation time was (106.1 ± 18.8) min,the mean EBL was (162.2 ±68.0) ml with no transfusion case.4 patients converted to conventional retroperitoneal laparoscopic partial nephrectomy,the operation time was 110-140 min,the EBL was 350-500 ml and the warm-ischemia time was 12-20 min respectively.The pathological outcome shows renal cell carcinoma in 24 patients and papillary renal cell carcinoma in 1 patient with all negative margins.The mean GFR of the operation side was (45.1 ± 10.2) ml/(min · 1.73 m2) after three months of the surgery and shows no statistical difference (P =0.268).Conclusion The application of the "four-quadrant" tumor target-artery positioning in " zeroischemia" retroperitoneal laparoscopic partial nephrectomy is a safety and feasible method in terms of accurate location of the target-artery,better postoperative renal function,low EBL and reasonable oncological outcomes.
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ObjectiveTo evaluate the effect of inlay buccal mucosa graft with tubularized incised urethral plates (TIP) urethroplasty for hypospadias repair. MethodsFrom January 2005 to December 2010,a total of 343 cases of hypospadias underwent a buccal mucosa graft with TIP urethroplasty.The patients aged from 6 months to 61 years,mean 7 years.One hundred and forty-seven were primary surgery cases,and 196 cases had a history of failed surgery.In primary cases,124 were distal type and 23 were proximal type.There were 137 distal type cases and 59 proximal types in failed case group.A buccal mucosa graft was harvested from lower lip,fixed into the incised urethral plates in primary cases.In re-do cases,open urethral and remove scar tissue were necessary. ResultsThe width of the buccal mucosa ranged 0.5 - 2.5 cm,length ranged 1.0 - 8.5 cm.All the patients were followed up for 6 - 36 months,average 16 months.In primary group,fistula occurred in 14 cases (9.5％ ),and urethral stricture in 2 cases (1.4％),in which 1 proximal case occurred both with urethral stricture and fistula; the overall success rate was 89.8％.In re-do group,fistula occurred in 32 cases ( 16.3％ ),and stricture in 13 cases (6.6％),in which 1 distal and 5 proximal cases occurred with both urethral stricture and fistula; the overall success rate was 80.1％. ConclusionsInlay buccal mucosal graft with TIP technique is an effective instrumentality for hypospadias repair because of its high successful rate,good cosmetic effect and without affecting on oral appearance and function in donor site.