意大利关于腹腔镜子宫肌瘤切除术并发症的多中心研究。
Italian multicenter study on complications of laparoscopic myomectomy.
作者信息
Sizzi Ornella, Rossetti Alfonso, Malzoni Mario, Minelli Luca, La Grotta Francesco, Soranna Liberato, Panunzi Simona, Spagnolo Rocco, Imperato Fabio, Landi Stefano, Fiaccamento Andrea, Stola Emilio
机构信息
Villa Valeria Hospital, Rome, Italy.
出版信息
J Minim Invasive Gynecol. 2007 Jul-Aug;14(4):453-62. doi: 10.1016/j.jmig.2007.01.013.
STUDY OBJECTIVE
To study intraoperative and postoperative complications of laparoscopic myomectomy and patients' characteristics influencing this risk.
DESIGN
Prospective study, with a review of the patient records by the first author (Canadian Task Force classification II-2).
SETTING
Four Italian referral centers.
PATIENTS
The incidence and type of complications occurring in 2050 laparoscopic myomectomies undertaken from January 1998 through December 2004 were recorded.
INTERVENTIONS
The surgical technique, as well as the expertise of the operators, was the same for the 4 centers. Injection of vasoconstrictive agents was used in 37%. The serosa was always incised in a vertical fashion; mechanical enucleation of the myoma was completed whenever possible; suture was performed in 1 or 2 layers with deep and large stitches swaged to 1 or 0 polyglactin sutures that were tied intracorporeally or extracorporeally.
MEASUREMENTS AND MAIN RESULTS
Single or multiple myomectomies (n = 2050) for symptomatic myomas measuring at least 4 cm in diameter were performed. Most patients (48%) had more than 1 myoma, with a maximum of 15 per patient (myomas removed for patients: 2.26 +/- 1.8, mean +/- SD). Myoma size ranged from 1 to 20 cm (mean 6.40 +/- 2.6 SD). Myomas smaller than 4 cm were removed during myomectomy for larger ones. Total complication rate was 11.1% (225/2050 cases). Minor complications accounted for 9.1% (187/2050 cases) and major complications for 2.02% (38/2050 cases). The most serious events were hemorrhages (14 cases, 0.68%) requiring blood transfusions in 3 cases (0.14%); 10 postoperative hematomas (0.48%, one in the broad ligament and 9 in the myomectomy scar); 1 bowel injury (0.04%); 1 postoperative acute kidney failure (0.04%); and 2 unexpected sarcomas (0.09%). Failure to complete planned surgery occurred in 7 cases (0.34%). Two patients were readmitted for surgery (0.09%): 1 had a laparoscopic hysterectomy because of a severe blood loss, and the other had drainage of a hematoma in the broad ligament. After a follow-up period of 41.70 +/- 23.03 months (mean +/- SD), 386 (22.9%) patients conceived, with a pregnancy rate in patients wishing pregnancy of 69.8%; among them, 1 (0.26%) recorded spontaneous uterine rupture at 33 weeks gestation. Odds ratio computed to estimate the risk of complications in relation to the patient characteristics showed that the probability of complications significantly rises with an increase in the number (more than 3 myomas OR: 4.46, p <.001) and with the intramural (OR: 1.48, p <.05) or the intraligamentous location of myomas (OR: 2.36, p <.01) whereas the myoma size seems to influence particularly the risk of major complications (OR: 6.88, p <.001).
CONCLUSIONS
This is one of the largest series reported of laparoscopic myomectomy and the first focused on complications. The complication rate appears to be better than acceptable in comparison with complication rates reported after laparotomic myomectomies. Laparoscopic myomectomy, when performed by an experienced surgeon, can be considered a safe technique with an extremely low failure rate and good results in terms of pregnancy outcome.
研究目的
研究腹腔镜子宫肌瘤剔除术的术中及术后并发症,以及影响该风险的患者特征。
设计
前瞻性研究,由第一作者回顾患者记录(加拿大工作组分类II-2)。
地点
四个意大利转诊中心。
患者
记录了1998年1月至2004年12月期间进行的2050例腹腔镜子宫肌瘤剔除术中发生的并发症的发生率和类型。
干预措施
4个中心的手术技术以及手术医生的专业水平相同。37%的患者使用了血管收缩剂注射。浆膜层始终采用纵行切开;尽可能采用肌瘤机械剥除术;用1或2层缝线进行缝合,使用带针的深而大的缝线,缝至1或0号聚乙醇酸缝线,在体内或体外打结。
测量指标及主要结果
对直径至少4cm的有症状子宫肌瘤进行单例或多例子宫肌瘤剔除术(n=2050)。大多数患者(48%)有1个以上肌瘤,每位患者最多有15个肌瘤(患者切除的肌瘤:2.26±1.8,均值±标准差)。肌瘤大小为1至20cm(平均6.40±2.6标准差)。小于4cm的肌瘤在切除较大肌瘤时一并切除。总并发症发生率为11.1%(225/2050例)。轻微并发症占9.1%(187/2050例),严重并发症占2.02%(38/2050例)。最严重的事件为出血(14例,0.68%),其中3例(0.14%)需要输血;10例术后血肿(0.48%,1例位于阔韧带,9例位于子宫肌瘤剔除术瘢痕处);1例肠损伤(0.04%);1例术后急性肾衰竭(0.04%);2例意外肉瘤(0.09%)。7例(0.34%)未完成计划手术。2例患者再次入院接受手术(0.09%):1例因严重失血行腹腔镜子宫切除术,另1例因阔韧带血肿引流。经过41.70±23.03个月(均值±标准差)的随访,386例(22.9%)患者受孕,希望妊娠的患者妊娠率为69.8%;其中,1例(0.26%)在妊娠33周时发生自发性子宫破裂。计算比值比以评估与患者特征相关的并发症风险,结果显示,随着肌瘤数量增加(超过3个肌瘤,比值比:4.46,p<0.001)以及肌瘤位于肌壁间(比值比:1.48,p<0.05)或韧带内(比值比:2.36,p<0.01),并发症发生概率显著升高,而肌瘤大小似乎尤其影响严重并发症的风险(比值比:6.88,p<0.001)。
结论
这是报道的最大系列腹腔镜子宫肌瘤剔除术之一,也是首个聚焦于并发症的研究。与开腹子宫肌瘤剔除术后报道的并发症发生率相比,该并发症发生率似乎处于可接受范围。由经验丰富的外科医生进行腹腔镜子宫肌瘤剔除术,可被视为一种安全的技术,失败率极低,妊娠结局良好。