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经阴道网片手术的安全性:684例患者的回顾性研究

Safety of Trans Vaginal Mesh procedure: retrospective study of 684 patients.

作者信息

Caquant Fréderic, Collinet Pierre, Debodinance Philippe, Berrocal Juan, Garbin Olivier, Rosenthal Claude, Clave Henri, Villet Richard, Jacquetin Bernard, Cosson Michel

机构信息

Gynaecological Surgery, Hospital Jeanne de Flandre, Lille Cedex, France.

出版信息

J Obstet Gynaecol Res. 2008 Aug;34(4):449-56. doi: 10.1111/j.1447-0756.2008.00820.x.

DOI:10.1111/j.1447-0756.2008.00820.x
PMID:18937698
Abstract

AIM

To study peri-surgical complications after cure of genital prolapse by vaginal route using interposition of synthetic prostheses Gynemesh Prolene Soft (Gynecare) following the Trans Vaginal Mesh (TVM) technique.

METHODS

The present retrospective multicentered study comprised 684 patients who underwent surgery at seven French centers between October 2002 and December 2004. All patients had a genital prolapse >or=3 (C3/H3/E3/R3) according to International continence society (ICS) classification. According to each case, prosthetic interposition was total, or anterior only or posterior only. Patients were systematically seen 6 weeks, 3 months and 6 months after surgery. Multivaried statistical analysis followed a model of logistic regression applied to each post-surgical complication.

RESULTS

The mean age of patients was 63.5 years (30-94). The mean follow-up period was 3.6 months. 84.3% of patients were post-menopause, 24.3% had hysterectomy, 16.7% previous cure of prolapse, and 11.1% cure of stress urinary incontinence (SUI). During the procedure, hysterectomy was combined in 50.3% of cases, cervix amputation in 1.5%, and cure of SUI in 40.9%. 15.8% were treated for a cystocele only. 14.8% had only a rectocele +/- elytrocele and 69.4% had a prolapse touching both compartments, anterior and posterior. In peri-surgical complications, (2%) were five bladder wounds (0.7%), one rectal wound (0.15%) and seven hemorrhages greater that 200 mL (1%). Among early post-surgical complications (during the first month after surgery) (2.8%) were two pelvic abscesses (0.29%), 13 pelvic hematomas (1.9%), one pelvic cellulitis (0.15%), two vesicovaginal fistulas and one rectovaginal fistula (0.15%). Among late post-surgical complications (33.6%) there were 77 granulomas or prosthetic expositions (11.3% [6.7% in the vaginal anterior wall, 2.1% in the vaginal posterior wall and 4.8% in the fornix]), 80 prosthetic retractions (11.7%), 36 relapse of prolapse (6.9%) and 37 SUI de novo (5.4%). Multivaried analysis shows that previous history of hysterectomy or placing of an isolated anterior prosthesis increase the risk of peri-surgical complication; preserved uterus and isolated posterior prosthesis lessen the risk of granulomas and prosthetic retractions; and association of a Richter's intervention increases the rate of prosthetic retractions.

CONCLUSION

Cure of genital prolapse with synthetic prostheses interposed by vaginal route is now reliable and can be reproduced with a low rate of peri- and early post-surgical complications. However, our study shows a certain number of late post-surgical complications after insertion of strengthening synthetic vaginal implants (prosthetic expositions and prosthetic retractions). These retrospective results will soon be compared to a prospective study.

摘要

目的

采用经阴道网片(TVM)技术,使用合成假体Gynemesh Prolene Soft(吉妮致美)置入术,经阴道途径治疗生殖器脱垂后,研究围手术期并发症。

方法

本回顾性多中心研究纳入了2002年10月至2004年12月期间在法国7个中心接受手术的684例患者。根据国际尿控协会(ICS)分类,所有患者生殖器脱垂均≥3度(C3/H3/E3/R3)。根据具体病例,假体置入可为全层、仅前路或仅后路。术后6周、3个月和6个月对患者进行系统随访。多变量统计分析采用逻辑回归模型,应用于每种术后并发症。

结果

患者平均年龄63.5岁(30 - 94岁)。平均随访期为3.6个月。84.3%的患者处于绝经后,24.3%曾行子宫切除术,16.7%既往有脱垂治愈史,11.1%有压力性尿失禁(SUI)治愈史。手术过程中,50.3%的病例同时行子宫切除术,1.5%行宫颈切除术,40.9%行SUI治愈术。15.8%仅治疗膀胱膨出。14.8%仅有直肠膨出±阴道膨出,69.4%的脱垂累及前后两个腔室。围手术期并发症中,有5例膀胱损伤(0.7%)、1例直肠损伤(0.15%)和7例出血量超过200 mL的出血(1%)。术后早期并发症(术后第一个月内)中,有2例盆腔脓肿(0.29%)、13例盆腔血肿(1.9%)、1例盆腔蜂窝织炎(0.15%)、2例膀胱阴道瘘和1例直肠阴道瘘(0.15%)。术后晚期并发症中(33.6%),有77例肉芽肿或假体暴露(11.3%[阴道前壁6.7%,阴道后壁2.1%,穹窿部4.8%])、80例假体回缩(11.7%)、36例脱垂复发(6.9%)和37例新发SUI(5.4%)。多变量分析显示,既往子宫切除史或单独置入前路假体增加围手术期并发症风险;保留子宫和单独置入后路假体降低肉芽肿和假体回缩风险;合并里氏手术增加假体回缩率。

结论

经阴道途径置入合成假体治疗生殖器脱垂目前是可靠的,围手术期和术后早期并发症发生率较低。然而,我们的研究显示,在置入增强型合成阴道植入物后,存在一定数量的术后晚期并发症(假体暴露和假体回缩)。这些回顾性结果不久将与一项前瞻性研究进行比较。

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