Lipofilling as a Treatment for Vestibulodynia
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状态招聘中
赞助商
University Hospital, Ghent
临床试验: NCT03431779
BioSeek: NCT03431779
关键词
抽象
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.
日期
| 最后验证: | 04/30/2018 |
| 首次提交: | 01/24/2018 |
| 提交的预估入学人数: | 02/11/2018 |
| 首次发布: | 02/12/2018 |
| 上次提交的更新: | 05/01/2018 |
| 最近更新发布: | 05/02/2018 |
| 实际学习开始日期: | 04/30/2018 |
| 预计主要完成日期: | 11/30/2019 |
| 预计完成日期: | 07/31/2020 |
状况或疾病
Vestibulodynia
干预/治疗
Procedure: Adipose derived stem cell transplantation via lipofilling
Procedure: Surgical excision
相
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手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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 |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Vestibulodynia requesting surgery Exclusion Criteria: - |
结果
主要结果指标
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.
