Elmér Caroline, Altman Daniel, Engh Marie Ellström, Axelsen Susanne, Väyrynen Tapio, Falconer Christian
From the Division of Surgery and Urology and Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital, Stockholm, Sweden; Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden; Department of Obstetrics and Gynaecology, Akershus University Hospital, University of Oslo, Lørenskog, Norway; Department of Obstetrics and Gynecology, Aarhus University Hospital, Skejby, Denmark; and Department of Obstetrics and Gynecology, Helsinki University Central Hospital, Jorvi Hospital, Espoo, Finland.
Obstet Gynecol. 2009 Jan;113(1):117-126. doi: 10.1097/AOG.0b013e3181922164.
To prospectively assess clinical outcomes after pelvic organ prolapse repair with a standardized trocar-guided surgical device using polypropylene mesh.
This was a prospective multicenter cohort study performed throughout 26 clinics. Evaluation at baseline, 2 months, and 1 year after surgery included prolapse grading using the pelvic organ prolapse quantification system (POP-Q) and symptom assessment using the Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6). For the purpose of this study, postoperative POP-Q stage 0-I was considered anatomic cure.
Two-hundred sixty-one patients were included in the study; 232 (89%) attended the 1-year follow-up. Mean+/-standard deviation age at surgery was 66.3+/-9.4 years. Anatomic cure 1 year after surgery was observed in 96 of 121 women (79%) after anterior repair with mesh (P<.001), and 56 of 68 (82%) after posterior repair with mesh (P<.001). For combined anterior and posterior mesh repair, cure was 51 of 63 (81%) and 54 of 63 (86%) for the anterior and posterior compartment, respectively (P<.001 for both). Bladder and rectal perforations occurred in 9 of 252 patients (3.4%). Vaginal erosions, the majority mild to moderate, occurred in 26 of 232 cases (11%). Surgical intervention due to mesh exposure occurred in seven cases (2.8%). There were significant quality-of-life improvements in all domains of the IIQ-7. Despite significant improvements in UDI-6 scores, symptoms specific for stress urinary incontinence were not ameliorated.
Trocar-guided transvaginal mesh surgery for pelvic organ prolapse is associated with satisfactory objective and subjective outcomes 1 year after surgery.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00402844
II.
前瞻性评估使用聚丙烯网片的标准化套管针引导手术器械进行盆腔器官脱垂修复术后的临床结局。
这是一项在26家诊所开展的前瞻性多中心队列研究。在基线、术后2个月和1年进行评估，包括使用盆腔器官脱垂定量系统（POP-Q）进行脱垂分级，以及使用尿失禁影响问卷（IIQ-7）和泌尿生殖系统困扰量表（UDI-6）进行症状评估。在本研究中，术后POP-Q 0-I期被视为解剖学治愈。
261例患者纳入研究；232例（89%）参加了1年随访。手术时的平均年龄±标准差为66.3±9.4岁。121例接受前路网片修补术的女性中，96例（79%）术后1年实现解剖学治愈（P<0.001）；68例接受后路网片修补术的女性中，56例（82%）术后1年实现解剖学治愈（P<0.001）。对于前后路联合网片修补术，前后盆腔分别有51例（81%）和54例（86%）治愈（两者P均<0.001）。252例患者中有9例（3.4%）发生膀胱和直肠穿孔。232例中有26例（11%）发生阴道糜烂，多数为轻至中度。7例（2.8%）因网片暴露而进行手术干预。IIQ-7所有领域的生活质量均有显著改善。尽管UDI-6评分有显著改善，但压力性尿失禁的特异性症状并未得到改善。
套管针引导经阴道网片手术治疗盆腔器官脱垂术后1年的客观和主观结局均令人满意。
ClinicalTrials.gov，www.clinicaltrials.gov，NCT00402844
II级
