Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving (INDIE)
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|ClinicalTrials.gov Identifier: NCT03080558|
Recruitment Status : Recruiting
First Posted : March 15, 2017
Last Update Posted : February 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Deep Endometriosis Recto Vaginal Node||Drug: Indocyanine green||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving, Using Indocyanine Green Injection. Feasibility Study|
|Actual Study Start Date :||August 6, 2017|
|Estimated Primary Completion Date :||February 28, 2019|
|Estimated Study Completion Date :||February 28, 2019|
|Experimental: endometriosis recto vaginal node||
Drug: Indocyanine green
Use of Indocyanine Green during Rectal shaving by laparoscopy.
- Per-operative evaluation of the rectum [ Time Frame: at day 1 ]Per-operative evaluation of the rectum after Shaving, using indocyanine green fluorescence, by transperitoneal and intra-rectal approach, and vaginal suture if there is an associated vaginal resection. A fluorescence score between 0 and 4 will be used, based on a Likert scale
- Side effects after indocyanine green injection [ Time Frame: at day 1 ]
- Post operative complications [ Time Frame: at day 1 ]infections, abdominal abscess, abdominal hematoma, post operative fistula.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080558
|Contact: Patrick LACARINfirstname.lastname@example.org|
|Clermont-Ferrand, France, 63003|
|Contact: Patrick LACARIN 04 73 75 11 95 email@example.com|
|Principal Investigator: Nicolas BOURDEL|
|Principal Investigator:||Nicolas BOURDEL||University Hospital, Clermont-Ferrand|