drugset / Trial / NCT03080558
Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving
Phase 4
Unknown
30 enrolled
University Hospital, Clermont-Ferrand
Association GEGO · collabLaboratoire SERB · collab
NaSingle-groupOpen-labelTreatment
Summary
Indocyanine green is a dye, using in surgery to bring out the intraoperative evaluation of tissue perfusion. After intravenous injection of indocyanine green, using a near infrared light, the vascularisation becomes fluorescent. In endometriosis disease, the treatment of recto vaginal node can be complicated by rectovaginal fistula. An abnormal vascularisation related to the surgery would be a risk factor of post operative fistulas. The aim of this study is to evaluate the rectal and vaginal vascularisation during the treatment of a recto vaginal endometriosis nodule with rectal shaving, using indocyanine green fluorescence.
Timeline
- Start
- 2017-08-06
- Primary completion
- 2019-02-28
- Completion
- 2019-02-28
Publications
- Bourdel N, Jaillet L, Bar-Shavit Y, Comptour A, Pereira B, Canis M, Chauvet P. Indocyanine green in deep infiltrating endometriosis: a preliminary feasibility study to examine vascularization after rectal shaving. Fertil Steril. 2020 Aug;114(2):367-373. doi: 10.1016/j.fertnstert.2020.03.042. Epub 2020 Jul 7.
- Bar-Shavit Y, Jaillet L, Chauvet P, Canis M, Bourdel N. Use of indocyanine green in endometriosis surgery. Fertil Steril. 2018 Jun;109(6):1136-1137. doi: 10.1016/j.fertnstert.2018.02.113. Epub 2018 Jun 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Indocyanine Green | Diagnostic / imaging agent | 0.2 mg/kg | Intravenous |