Division of Obstetrics and Gynecology, Department of Clinical Science, Danderyd Hospital, Stockholm, Sweden.
N Engl J Med. 2011 May 12;364(19):1826-36. doi: 10.1056/NEJMoa1009521.
The use of standardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years, but it is unclear whether this approach results in better outcomes than traditional colporrhaphy.
In this multicenter, parallel-group, randomized, controlled trial, we compared the use of a trocar-guided, transvaginal polypropylene-mesh repair kit with traditional colporrhaphy in women with prolapse of the anterior vaginal wall (cystocele). The primary outcome was a composite of the objective anatomical designation of stage 0 (no prolapse) or 1 (position of the anterior vaginal wall more than 1 cm above the hymen), according to the Pelvic Organ Prolapse Quantification system, and the subjective absence of symptoms of vaginal bulging 12 months after the surgery.
Of 389 women who were randomly assigned to a study treatment, 200 underwent prolapse repair with the transvaginal mesh kit and 189 underwent traditional colporrhaphy. At 1 year, the primary outcome was significantly more common in the women treated with transvaginal mesh repair (60.8%) than in those who underwent colporrhaphy (34.5%) (absolute difference, 26.3 percentage points; 95% confidence interval, 15.6 to 37.0). The surgery lasted longer and the rates of intraoperative hemorrhage were higher in the mesh-repair group than in the colporrhaphy group (P<0.001 for both comparisons). Rates of bladder perforation were 3.5% in the mesh-repair group and 0.5% in the colporrhaphy group (P=0.07), and the respective rates of new stress urinary incontinence after surgery were 12.3% and 6.3% (P=0.05). Surgical reintervention to correct mesh exposure during follow-up occurred in 3.2% of 186 patients in the mesh-repair group.
As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events. (Funded by the Karolinska Institutet and Ethicon; ClinicalTrials.gov number, NCT00566917.).
近年来，标准化网片套件在治疗盆腔器官脱垂中的应用迅速普及，但与传统的阴道修补术相比，这种方法是否能带来更好的效果尚不清楚。
在这项多中心、平行组、随机、对照试验中，我们比较了经阴道引导的、带聚丙烯网片的修复套件与传统阴道修补术在治疗前阴道壁脱垂（膀胱膨出）女性中的应用。主要结局是根据盆腔器官脱垂量化系统（Pelvic Organ Prolapse Quantification system），将客观解剖学指定为 0 期（无脱垂）或 1 期（前阴道壁位置高于处女膜 1 厘米以上），以及术后 12 个月无阴道膨出症状的主观缺失。
在 389 名随机分配至研究治疗的女性中，200 名接受经阴道网片修复，189 名接受传统阴道修补术。在 1 年时，经阴道网片修复组的主要结局更为常见（60.8%），而传统阴道修补术组为 34.5%（绝对差异，26.3 个百分点；95%置信区间，15.6 至 37.0）。网片修复组的手术时间更长，术中出血量也高于阴道修补术组（均 P<0.001）。网片修复组膀胱穿孔率为 3.5%，阴道修补术组为 0.5%（P=0.07），术后新发生压力性尿失禁的比例分别为 12.3%和 6.3%（P=0.05）。在随访期间，有 3.2%的网片修复组 186 名患者需要手术纠正网片暴露。
与传统阴道修补术相比，使用标准化、经阴道引导的网片套件治疗膀胱膨出可获得更高的短期治疗成功率，但也会导致更高的手术并发症和术后不良事件发生率。（由卡罗林斯卡学院和 Ethicon 资助；ClinicalTrials.gov 编号，NCT00566917。）
