Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving

NCT03080558 — Phase 4, Unknown, 30 participants, University Hospital, Clermont-Ferrand

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Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving, Using Indocyanine Green Injection. Feasibility Study

Registry	NCT03080558, acronym INDIE
Status	Unknown
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	30 (Estimated)
Sponsor	University Hospital, Clermont-Ferrand (Other); collaborators: Laboratoire SERB, Association GEGO
Conditions	Deep Endometriosis, Recto Vaginal Node
Interventions	Indocyanine green (Drug)
Dates	start 2017-08-06, primary completion 2019-02-28 (estimated), completion 2019-02-28 (estimated), first posted 2017-03-15, last updated 2019-02-04
Locations	1 site in France

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
endometriosis recto vaginal node	Experimental	Drug: Indocyanine green

Indocyanine green (Drug): Use of Indocyanine Green during Rectal shaving by laparoscopy.

+Outcome measures

Primary outcomes

Per-operative evaluation of the rectum [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

Secondary outcomes

Side effects after indocyanine green injection [at day 1]
Post operative complications [at day 1]: infections, abdominal abscess, abdominal hematoma, post operative fistula.

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

* Patients above the age of 18 year
* Patients with endometriosis recto vaginal node
* Patients with operative indications of rectal shaving, with or without vaginal resection
* Patients who have accepted to participate

Exclusion Criteria:

* minors patients
* Patients under guardianship or wardship
* Patients who refused the participation
* Iodine allergy
* Pregnant woman
* Patients during lactation

+Locations (1)

Facility	City	Country	Status
CHU Clermont-Ferrand	Clermont-Ferrand	France	Recruiting

+Publications

Results publication: 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. PMID 32646588
Results publication: 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. PMID 29885885

+Investigators

Nicolas BOURDEL, Principal investigator, University Hospital, Clermont-Ferrand

+Funding

NIH grants: 2016