Clinical Study Of Using Prolift^TM To Treat Pelvic Organ Prolapse

BackgroundPelvic organ prolapse(POP) refers to genital tract prolapse which is due to defectiveness of the genital supportive tissue.POP is a serious social and life problem with high incidence rate and incurs heavy financial burdens.The treatments of the POP can be either conservative or surgical.For light POP,the first choice is conservative,Only when the treatment is invalid,should surgical treatment be undertaken.The surgical treatment of POP dates back to long time ago and boasts a great variety,the most typical of which is transvaginal hysterectomy(herafter referred as TVH) plus repair of vaginal anterior and posterior wall.With the further anatomic understanding of the pelvic floor,modern pelvic anatomy emphasize that the pelvic floor should be existing as a whole,the improvement of surgical instruments as well as the invention and application of new repair materials,many new surgical methods evolved.The Prolift suspensory is a new surgical method which is building on the integry theory,with the aim to reconstruct the pelvic structure,as well as to reinstate the pelvic function.Prolift suspensory can better repair the defects of pelvic floor,and the recurrence rate of this surgery is lower.The short-term and mid-term effect are stable and the long-term effect need further observation.ObjectiveTo investigate the clinical significance of Total Prolift suspensory and TVH plus repair of vaginal anterior and posterior wall on the treatment of POP.Materials and MethodsSubjects:forty-two patients with POP who have undergone operation at QiLu Hospital from November 2007 to March 2008 was selected.Among the 42 patients,40cases are uterine prolapse,2 cases are fundus of vaginal prolapse,40 cases are vaginae anterior prolapse,40 cases are vaginae posterior prolapse.1 case accompaned old perineal laceration,and all their POP-Q stage wereⅡ～Ⅳ.The ages of the patients range from 29 to 86,with the average of 62.31 years.None of the patients have smoking or excessive drinking.None of the patients received hormone replacement therapy.The patients were divided into two groups:the study group 22 cases and the control group 20 cases.In the study group,all patients received Total Prolift suspensory,among which 20 received Total Prolift suspensory without hysterectomy as study group 1 and 2 received Prolift routine surgery as study group 2.In the control group 20 were given routine traditional vaginal hysterectomy plus repair of anterior and posterior wall of the vagina.Methods:1.Operation indication:all patients with invalid conservative treatment,but:1.1.Prolift suspensory without hysterectomy(1)Uterine prolapse,＞POP-QⅡ.(2)vaginae anterior prolapse,＞POP-QⅡ.(3)vagi nae posterior prolapse,＞POP-QⅡ.(4)the patients require to reserve uterus without malignant disease.1.2.Prolift suspensory after hysterectomy(1)fornix of vaginal prolapse,＞POP-QⅡ.(2)vaginae anterior prolapse,＞POP-QⅡ.(3)vaginae posterior prolapse,＞POP-QⅡ.1.3.TVH plus repair of vaginal anterior and posterior wall:(1)POP,＞POP-QⅡ.(2)without reproductive need.(3)without malignant diseases.2.Surgical methods:In study group 1,20 patients received the Total Prolift suspensory without hysterectomy,in study group 2,2 patients received Total Prolift suspensory after hysterectomy,in the control group,20 patients received TVH plus repair of anterior and posterior wall of the vagina.3.SPSS16.0 was used for statistical analysis.T-test was used to process the data of the two patient groups,such as operation time,amount of bleeding,indwelling catheter time,mean in-hospital time post-operation,et al,and the result is measured by mean±standard deviation.Non-parametric test was used to procee the degree of POP.The contrast between the groups in surgical cure rate,the recurrence rate,and postoperative complications is measued by X~2 test.Statistical analysis is undertaken with a=0.05 as the test standard.Results1.Analysis of clinical information:There were no significant difference between the groups in the general situation of the patient,for example,age,body mass index, delivery ways,reproductive history,menopause(P＞0.05).There was no significant difference between the groups about the degree of POP,either.2.Information on the operation:Operation time:The average operation time of study group 1 was 61.75±7.12minutes,and the average operation time of study group 2 was 65.00minutes, while the average operation time of the control group was 132.00±38.20 minutes. There was significant difference of operation time between study group and the control group,(P＜0.05).Bleeding during the operation:For study group 1 the average amount of bleeding was 47.50±18.03ml,for study group 2 the average amount of bleeding was 65.09±49.50ml,and for the control group the average amount of bleeding was 154.50±87.15ml.There was significant difference between study group and the control group(P＜0.05).Indwelling catheter time:No significant difference was found(P＞0.05).Mean in-hospital time post-operation:For study group 1 it was 7.55±2.14 days, for study group 2 was 8.50±2.12 days,and for the control group it was 11.60±7.34days. Study group 1 is significantly shorter than the control groups(P＜0.05),while there is no significant difference between study group 2 and the control group(P＞0.05).As to the rate of complications after the operation,there is no urinary retention or post-operation morbidity,but 1 case showed up mesh erosion;however,in the control group,1 case appeared post-operation morbidity;1 case appeared urinary retention.There is no significant difference between the two groups(P＞0.05).3.Clinical evaluation after operation:Examination result of POP-Q:The POP-Q degrees of the three groups are all at the cured level 0 orⅠ.The comparison of vaginal length:the average vaginal lengths before and after operation are 6.45±0.73cm,6.34±0.73cm for study group 1,6.75±0.35cm, 6.85±0.50cm for study group 2,and 6.60±0.84cm,5.84±0.75cm for the control group. There is no statistically significant difference among the three groups in terms of vaginal length before the operation(P＞0.05).After operation,the vaginal length of the control group is significantly shorter than that before the operation.The vaginal length of study group 1 and study group 2 did not show significant change after the operation,but co-mpared with the control group,there was significant difference respectively(P＜0.05).4.Follow-up:The time of follow-up ranged from 1 to 15 months,and the average of the follow-up was 8 months.The rate of follow-up was 100%.Recurrence rate:In the study group,there was one case of recurrence rate;the cure rate is 95.45%,and the recurrence rate is 4.55%.In the control group there were 3 cases of recurrence;the cure rate is 75.00%and the recurrence is 15.00%.The recurrence rate of the study group is lower than that of the control group,but there is no statistically significant difference(P＞0.05).Conclusion1.TVH plus repair of vaginal anterior and posterior wall and Prolift suspensory are both effective ways in the treatment of POP.2.As a new surgical technique,Total Prolift suspensory can better repair the defects and realize the structural reconstruction and tissue replacement.The recurrence rate of Prolift surgery is lower.The short-term and mid-term effects are stable and the long-term effect needs further observation.