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A Long Term Follow up of Anterior Meshes for Recurrent Prolapse

2017年9月17日 更新者:Professor Jonathan Duckett、Medway NHS Foundation Trust

A Long Term Follow up of Perigee Anterior Meshes Performed for Recurrent Prolapse

Prolapse of the vaginal wall and uterus are common conditions affecting up to 50% of parous women. The socioeconomic, psychological and physical impacts of prolapse are considerable. 11% of women will undergo a surgical repair by the age of 80 years. The commonest compartment affected is the anterior vaginal wall. Unfortunately there is a significant rate of recurrent prolapse or a failure of the primary procedure. This has lead to the introduction of new techniques and the use of different materials to augment the repair. Mesh augmented repairs aim to reduce the rate of recurrent prolapse. However, the use of synthetic mesh is associated with complications which are not found in non mesh repairs. 10% of women will have a mesh complication of which 70% will require a further surgical procedure to manage the complication. There are extra costs associated with purchasing the mesh, with longer operating times to insert the mesh and managing complications caused by the mesh. Balancing the extra risks of mesh surgery against the benefits is probably one of the most contentious issues in urogynaecology at the present time.

Regulatory authorities in the USA (FDA) and UK (MHRA) have become increasingly interested in the use of mesh to support the vaginal wall in prolapse surgery due to risks and complications being reported. To date there is little evidence regarding the long term safety and efficacy of anterior mesh repairs. This study aims to rectify this deficiency for Perigee.

研究概览

详细说明

This will be a consecutive cohort study of patients identified from a surgical database of Perigees performed in a single centre. All patients will have had the procedure performed between 2007 and 2011. This will be a single centre study. The principle investigator has both electronic and hand written records of all Perigee repairs performed since the introduction of this technique in 2007. The patients will be identified from both the paper and electronic databases and cross referenced.

After obtained appropriate ethical approval, patients identified as having a perigee mesh inserted will be asked to attend Medway Hospital for a full clinical evaluation. They will be sent a letter with an appointment to come to the hospital. They will be asked to complete the Pelvic floor distress inventory questionnaire to assess their symptoms. They will have a pelvic examination to determine if they have any mesh erosion and will undergo a POP-Q score. This visit will take 1 hour.

研究类型

观察性的

注册 (实际的)

48

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Kent
      • Gillingham、Kent、英国、ME5 7NY
        • Medway NHS Foundation Trust

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 100年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

取样方法

非概率样本

研究人群

Consecutive patients having previously undergone a mesh repair

描述

Inclusion Criteria:

  • Women undergoing a perigee procedure after January 2007

Exclusion Criteria:

  • Patient having non mesh repairs over the same time scale

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The Number of Participants With a Current Mesh Erosion or Treated for a Mesh Erosion Since Inserted
大体时间:1 hour
clinic visit. 5 patients were interviewed by phone and were not examined - hence this figure is out of 43 not 48.
1 hour

次要结果测量

结果测量
措施说明
大体时间
Number of Participants With no Physical Evidence of Recurrent Prolapse as Determined by Physical Examination
大体时间:1 hour

The presence of less than stage 2 prolapse (eg stage 1) anterior wall prolapse determined as anatomical success. A stage one prolapse is higher than 1cm above the vaginal entrance.

A stage 2 prolapse means that the leading edge of the prolapse is between 1cm above the entrance to the vagina up to 1cm below the entrance to the vagina.

1 hour
Number of Participants Complaining of a Bulge. Recurrent Prolapse
大体时间:1 hour
Efficacy determined by the question in the pelvic floor prolapse distress inventory "usually have a bulge or something falling out that you can see or feel in your vaginal area". Determined at clinic visit by questioning
1 hour
Number of Participants Requiring Treatment for Recurrent Prolapse - Prolapse in the Same Part of the Vagina
大体时间:1 hour
clinic visit; number of participants who underwent reoperation of recurrent prolapse in the same compartment
1 hour
Number of Participants Who Underwent Reoperation for Prolapse in a Different Compartment
大体时间:1 hour
This is where the mesh has held up and there is no prolapse where it was inserted. This measure refers to when a different part of the vagina has prolapsed.
1 hour
Number of Participants Who Developed New Stress Incontinence
大体时间:1 hour
The mesh has caused the prolapse to be successfully repaired but the patient has developed stress incontinence as a separate issue. clinic visit
1 hour
Number of Participants Who Rated Their Improvement as Better or Very Much Better
大体时间:1 hour
The patient global impression of Improvement scale (PGI-I) is a global improvement scale filled out by the patient. It is graded as very much better, much better, a little better. no change, a little worse, much worse or very much worse.clinic visit
1 hour
Number of Participants Who Needed Surgical Mesh Removal for Erosion
大体时间:1 hour
A mesh erosion is when the body rejects the mesh and it is visible in the vagina rather than being buried under the vaginal epithelium. clinic visit
1 hour
Number of Participants Who Needed Reoperations for Pain
大体时间:1 hour
patients may develop pain after the original operation which needs a second surgical procedure to try and help. clinic visit
1 hour
Number of Participants Who Experienced Intraoperative Complications
大体时间:1 hour
This records any problems that were encountered at the original insertion of the mesh. clinic visit
1 hour

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jonathan Duckett, FRCOG、Medway NHS Foundation Trust

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年8月1日

初级完成 (实际的)

2016年3月1日

研究完成 (实际的)

2016年3月1日

研究注册日期

首次提交

2015年8月27日

首先提交符合 QC 标准的

2015年12月27日

首次发布 (估计)

2015年12月30日

研究记录更新

最后更新发布 (实际的)

2018年5月29日

上次提交的符合 QC 标准的更新

2017年9月17日

最后验证

2016年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 9/12/14

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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