Lipofilling as a Treatment for Vestibulodynia
Yalnız qeydiyyatdan keçmiş istifadəçilər məqalələri tərcümə edə bilərlər
Giriş / Qeydiyyatdan keçin
Bağlantı panoya saxlanılır
Statusİşə qəbul
Sponsorlar
University Hospital, Ghent
KLINIK SINAQ: NCT03431779
BioSeek: NCT03431779
Açar sözlər
Mücərrəd
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.
Tarixlər
| Son Doğrulandı: | 04/30/2018 |
| İlk təqdim: | 01/24/2018 |
| Təxmini qeydiyyat təqdim edildi: | 02/11/2018 |
| İlk Göndərmə: | 02/12/2018 |
| Son Yeniləmə Göndərildi: | 05/01/2018 |
| Son Yeniləmə Göndərildi: | 05/02/2018 |
| Həqiqi Təhsilin Başlama Tarixi: | 04/30/2018 |
| Təxmini İlkin Tamamlanma Tarixi: | 11/30/2019 |
| Təxmini İşin Tamamlanma Tarixi: | 07/31/2020 |
Vəziyyət və ya xəstəlik
Vestibulodynia
Müdaxilə / müalicə
Procedure: Adipose derived stem cell transplantation via lipofilling
Procedure: Surgical excision
Faza
-
Qol Qrupları
| Qol | Müdaxilə / müalicə |
|---|---|
| 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 |
Uyğunluq Kriteriyaları
| Təhsil üçün uyğun yaşlar | 18 Years Üçün 18 Years |
| Təhsilə Uyğun Cinslər | Female |
| Sağlam Könüllüləri qəbul edir | Bəli |
| Kriteriyalar | Inclusion Criteria: - Vestibulodynia requesting surgery Exclusion Criteria: - |
Nəticə
İlkin nəticə tədbirləri
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.
