盆底修复系统治疗盆腔脏器脱垂的疗效分析和安全性探讨

Safety and efficacy of pelvic reconstruction system for the treatment of pelvic organ prolapse

目的探讨应用盆底修复系统(Avaulta系统)治疗盆腔脏器脱垂(POP)的安全性和有效性。方法选择2014年2月—2015年3月在同济大学附属同济医院因POP需行手术治疗的66例患者,并应用Avaulta系统对患者行盆底重建手术。完善术前准备,记录患者围术期评价指标;于术后6周、3个月、6个月进行门诊随访,对比术前与术后各时间点患者盆腔脏器脱垂定量(POP-Q)分期、并发症发生情况;通过盆底功能影响量表(PFIQ-7)和盆腔脏器脱垂生活质量量表(P-QOL)评估患者术前、术后6个月盆底功能和生活质量改善情况。结果纳入患者年龄为(64.36±9.20)岁,体重为(60.72±8.78)kg,身高为(157.67±4.87)cm;术前POP-Q分期为Ⅱ期6例、Ⅲ期46例和Ⅳ期14例;行前盆腔盆底重建手术59例,行后盆腔盆底重建手术5例,行全盆腔盆底重建手术2例;术中联合行经阴道和闭孔尿道中段无张力悬吊术(TVT-O)1例,行全子宫切除术6例,行宫颈切除术3例。术后6周失访2例,术后3个月失访6例,术后6个月失访7例,完成随访患者59例。患者手术时间为(51.79±29.58)min,无术后并发症发生;术后次日,患者外周血血红蛋白值、血尿发生率、ALT和AST水平与术前相比,差异均无统计学意义(P值均>0.05)。均于术后3 d拔除导尿管,2例患者出现排尿困难,予重置导尿管2周后拔除;术后6周,1例患者发生局部感染,予甲硝唑栓抗感染治疗。术后患者疼痛总发生率为17.19%(11/64),多数可自行缓解。术后6个月,5例患者新发压力性尿失禁,症状较轻,未予特殊处理。术后6个月,4例患者出现便秘,予口服缓泻剂、开塞露通便后症状缓解。术后6周,患者POP-Q分期均<Ⅱ期,2例为Ⅰ期,治疗有效率为100.00%(64/64);术后3个月,1例患者POP-Q分期为Ⅱ期,5例为Ⅰ期,治疗有效率为98.33%(59/60);术后6个月,1例患者POP-Q分期为Ⅱ期,6例为Ⅰ期,有效率为98.31%(58/59);术后多数患者盆底解剖形态较术前显著恢复(P<0.05)。术前患者PFIQ-7评分为131.45(55.24,102.30)分,术后6个月PFIQ-7评分为11.22(4.35,80.96)分,患者盆底功能均显著改善(P<0.05);对患者6项指标(日常生活、体力劳动、社会活动、情绪、性生活和睡眠质量)行P-QOL评价显示,术后多数患者生活质量均较术前显著改善(P值均<0.05)。结论盆底修复系统治疗POP安全、有效,可显著改善患者的生活质量,其疗效与术者操作技巧和手术经验密切相关。

Objective To verify the safety and efficacy of pelvic floor reconstruction system(Avaulta system)for pelvic organ prolapse(POP).Methods A total of 66 POP patients treated surgically by Avaulta system from February 2014 to March 2015 were enrolled in this study.Clinical parameters during operation were recorded.Outpatient follow-up was conducted at 6 weeks,3 months and 6 months after surgery.Pelvic organ prolapse quantitative examination(POP-Q)and complications in these patients were analyzed.Pelvic floor function and quality of life were evaluated by using pelvic floor impact questionnaire-short form 7(PFIQ-7)and pelvic organ prolapse quality of life questionnaire(P-QOL)before surgery and 6 months after surgery.Results The patients were(64.36±9.20)years old,weighed(60.72±8.78)kg,and had a height of(157.67±4.87)cm.There were 6 patients with POP stageⅡ,46 patients with stageⅢ,and 14 patients with stageⅣ.Anterior pelvic floor reconstruction was performed in 59 patients,posterior pelvic floor reconstruction in 5 patients,and whole pelvic floor reconstruction in 2 patients.Additionally,tension-free vaginal tape-obturator(TVT-O)was done in one patient,total abdominal hysterectomy in 6 patients and radical trachelectomy in 3 patients.A total of 59 patients were finally followed up(lost to follow-up:2 cases at 6 weeks postoperatively,6 cases at 3 months and 7 cases at 6 months).The mean operation time was(51.79±29.58)min.No postoperative complications occurred.The incidence of hematuria,the levels of hemoglobin,alanine aminotransfease and aspartate transaminase at the next day after operation were not statistically different from those before surgery(all P>0.05).Urethral catheter was removed 3 days after surgery in all patients.Two patients had difficulty in urinating,and the catheter was used again and removed 2 weeks later.After 6 weeks,one patient had local infection and was treated with metronidazole.The total incidence of postoperative pelvic pain was 17.19%(11/64),and the pain in most patients was able to relieve themselves.Within 6 months after surgery,5 patients developed new stress urinary incontinence,with mild symptoms and no treatment.Meanwhile,4 patients had constipation and were given oral laxative or enema.At 6 weeks after surgery,the POP-Q staging was less than stageⅡin all patients,2 cases were at stageⅠ,and the effective rate was 100.00%(64/64).At 3 months after surgery,1 case was at stageⅡ,and 5 cases were at stageⅠ,and the effective rate was 98.33%(59/60).At 6 months after surgery,1 case was at stageⅡ,6 cases were at stageⅠ,and the effective rate was 98.31%(58/59).The anatomy of postoperative pelvic floor was significantly restored(P<0.05).The score of PFIQ-7 was 131.45(55.24,102.30)before operation and 11.22(4.35,80.96)at 6 months after operation,and the pelvic floor function was significantly improved(P<0.05).P-QOL evaluation,including daily life,physical labor,social activities,emotions,sex life and sleep quality,showed that the quality of life of patients was significantly improved after surgery(all P<0.05).Conclusion Pelvic floor reconstruction system is safe and effective in treatment of POP.The clinical effect is closely related to the operation skill and experience of surgeons.