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临床试验/NCT03766048
NCT03766048招募中不适用

Non-inferiority Randomized Double Blind Controlled Trial Comparing Results of Laparoscopic Sacrocolpopexy With or Without Preventive Prerectal Mesh in Women Operated for Urogenital Prolapse Without Significant Posterior Vaginal Wall Prolapse

University Hospital, Lille12 个研究点 分布在 1 个国家目标入组 834 人开始时间: 2019年9月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
834
试验地点
12
主要终点
Composite criteria of success at 2 years follow-up

研究概览

简要总结

Urogenital prolapse is a frequent and invalidating pathology in women, involving the anterior vaginal wall and the uterus in most cases. Posterior vaginal wall prolapse is present in only 50% of cases. Surgery is an option for women with troublesome prolapse. A woman's lifetime risk of undergoing surgery for pelvic organ prolapse (POP) surgery by the age of 80 is around 19%. Laparoscopic sacrocolpopexy (LS) with synthetic non-absorbable mesh is considered the gold standard, with a composite success rate of 85% at one year (Prospere study). Based on early experience and historical habits, a prerectal mesh was used to be systematically placed in the rectovaginal space, in addition to the anterior and apical mesh placed in the vesicovaginal space, in order to prevent de-novo posterior prolapse (reported rates up to 33%).

The benefit of preventive prerectal mesh is questionned on the basis of a single retrospective study comparing 68 LS with double-mesh (anterior & posterior, DM) to 32 LS with a single anterior mesh (SAM): posterior recurrence rates were respectively 5.9 vs. 31.3% (p<0,01), and total recurrence rates 16.2 vs. 43.8% (p<0.01). However, as this difference was not significant in the subgroup of patients without associated cervicocystopexy, the authors concluded that the risk of posterior failure was only due to the cervicocystopexy itself (anti-urinary incontinence procedure which has been abandoned since).

On the other hand, a prerectal mesh increases the risk for specific complications: rectal injury (up to 3%), anal pain (up to 25%), mesh exposition (up to 2%). Furthermore the posterior mesh increases the procedure by a minimum of 30 minutes (Robolaps study, unpublished data). The rate of de-novo obstructed defecation after LS with prerectal mesh is reported up to 25%. It could be explained by the mesh itself, but also by nerve injuries during the dissection of the rectovaginal space and rectal stalks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with a urogenital prolapse (anterior wall and/or uterus or vaginal apex) stage = 2 (Ba and/or C points ≥ - 1 cm using the POP-Q system),
  • without significant posterior vaginal wall prolapse (Bp < -1 cm when apical prolapse is reduced using a retractor leaving the posterior vaginal wall free),

排除标准

  • Previous surgical repair for Pelvic Organ Prolapse
  • Any associated prolapse requiring any non-authorized additional surgical repair (Authorized additional surgical procedures are hysterectomy, ovariectomy, adnexectomy, salpingectomy, myomectomy, or suburethral vaginal tape.)
  • Wish for future pregnancy
  • Lack of health insurance
  • Woman not reading French or unable to consent
  • Woman under law protection

研究组 & 干预措施

Single-Anterior-Mesh, SAM

Experimental

干预措施: Single-Anterior-Mesh, SAM (Procedure)

Double-Mesh, DM

Sham Comparator

干预措施: Double-Mesh, DM (Procedure)

结局指标

主要结局

Composite criteria of success at 2 years follow-up

时间窗: at 2 years after the intervention

Composite criteria of success at 2 years follow-up: no symptom of vaginal bulge, no prolapse beyond the hymen (\>0 cm), no reintervention for prolapse recurrence. Its advantage is that it considers only recurrences that are symptomatic or needing a reintervention. It is strongly linked with women satisfaction after prolapse surgery.

次要结局

  • Anatomical results(at 2 years)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (12)

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