Lipofilling as a Treatment for Vestibulodynia
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状態募集
スポンサー
University Hospital, Ghent
臨床試験: NCT03431779
BioSeek: NCT03431779
キーワード
概要
The investigators would like to investigate if lipofilling with its adipose derived stem cells (ADSC) could be a new, less invasive but equally or more effective therapeutic option for women with vestibulodynia than vestibulectomy. The investigators expect the study to be successful because of the anti-inflammatory effects of the ADSC and its effectiveness -although not thoroughly studied- in some neuropathic pain disorder like pudendal neuralgia or post mastectomy pain syndrome.
Method: A controlled intervention study: one group receiving golden standard therapy 'vestibulectomy' and one group receiving vestibular lipofilling.
日付
| 最終確認済み: | 04/30/2018 |
| 最初に提出された: | 01/24/2018 |
| 提出された推定登録数: | 02/11/2018 |
| 最初の投稿: | 02/12/2018 |
| 最終更新が送信されました: | 05/01/2018 |
| 最終更新日: | 05/02/2018 |
| 実際の研究開始日: | 04/30/2018 |
| 一次完了予定日: | 11/30/2019 |
| 研究完了予定日: | 07/31/2020 |
状態または病気
Vestibulodynia
介入/治療
Procedure: Adipose derived stem cell transplantation via lipofilling
Procedure: Surgical excision
段階
-
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Adipose derived stem cell transplantation via lipofilling Liposuction of 60cc abdominal fat with its adipose derived stem cells which will be reinjected (10-20 cc) in the vestibular area after centrifugation for 3 minutes at 1000 rpm and decantation of oil and red blood cells. | Procedure: Adipose derived stem cell transplantation via lipofilling Liposuction of 60cc abdominal fat with its adipose derived stem cells which will be reinjected (10-20 cc) in the vestibular area after centrifugation for 3 minutes at 1000 rpm and decantation of oil and red blood cells. |
| Active Comparator: Surgical excision Excision of painful areas | Procedure: Surgical excision Excision of painful areas |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | Female |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - Vestibulodynia requesting surgery Exclusion Criteria: - |
結果
主な結果の測定
1. Q-tip scores (Cotton swab assessment of vaginal pain) 3 months after surgery [3 months after surgery]
Very light pressure along specific points in the area of the vulvar vestibule and where there is tenderness, asking the patient to characterize the tenderness on a scale of 0-10, whether it's no pain or exquisite pain and then plotting that on a diagram. Most physicians will find that in women with vestibulitis, the tenderness is most pronounced just below the hymenal margin and around the orifices of the so-called "Bartholin" gland ducts.
