Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-01-10 @ 7:42 PM
Study NCT ID:
NCT03080558
Status:
UNKNOWN
Last Update Posted:
2019-02-04
First Post:
2017-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving, Using Indocyanine Green Injection. Feasibility Study
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INDIE
Brief 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.
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.
Detailed Description:
Investigators are going to inject, at the end of a rectal shaving, a bolus of 0,2mg/kg of indocyanine green after dilution (2,5mg/ml). With de SPIES system (KARL STORZ GmbH \& Co. KG, Tuttlingen, Germany), the vascularisation would be imediately fluorescent. Investigators are going to estimate the vascularization of the rectal serosa and mucosa where the nodule was located.
If a vaginal resection has been performed, investigators are going to estimate the vascularization of the vaginal scar.
To estimate de vascularization, investigators are going tu use a scale with a score between 0 and 4.
After the surgery, the post-operative follow-up with be the same as usual after a Rectal Shaving.
If a vaginal resection has been performed, investigators are going to estimate the vascularization of the vaginal scar.
To estimate de vascularization, investigators are going tu use a scale with a score between 0 and 4.
After the surgery, the post-operative follow-up with be the same as usual after a Rectal Shaving.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-002773-35 | OTHER | 2016-002773-35 | View |