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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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (実際)

48

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • イギリス
    • Kent
      • Gillingham、Kent、イギリス、ME5 7NY
        • Medway NHS Foundation Trust

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～100年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

サンプリング方法

非確率サンプル

調査対象母集団

Consecutive patients having previously undergone a mesh repair

説明

Inclusion Criteria:

  • Women undergoing a perigee procedure after January 2007

Exclusion Criteria:

  • Patient having non mesh repairs over the same time scale

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
The Number of Participants With a Current Mesh Erosion or Treated for a Mesh Erosion Since Inserted
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants With no Physical Evidence of Recurrent Prolapse as Determined by Physical Examination
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：1 hour
This records any problems that were encountered at the original insertion of the mesh. clinic visit
1 hour

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Medway NHS Foundation Trust

捜査官

  • 主任研究者：Jonathan Duckett, FRCOG、Medway NHS Foundation Trust

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2015年8月1日

一次修了 (実際)

2016年3月1日

研究の完了 (実際)

2016年3月1日

試験登録日

最初に提出

2015年8月27日

QC基準を満たした最初の提出物

2015年12月27日

最初の投稿 (見積もり)

2015年12月30日

学習記録の更新

投稿された最後の更新 (実際)

2018年5月29日

QC基準を満たした最後の更新が送信されました

2017年9月17日

最終確認日

2016年3月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 9/12/14

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