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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
Sponsor:
Collaborators:
Laboratoire SERB
Association GEGO
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment Phase
Deep Endometriosis Recto Vaginal Node Drug: Indocyanine green Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: open
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: endometriosis recto vaginal node Drug: Indocyanine green
Use of Indocyanine Green during Rectal shaving by laparoscopy.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Side effects after indocyanine green injection [ Time Frame: at day 1 ]
  2. Post operative complications [ Time Frame: at day 1 ]
    infections, abdominal abscess, abdominal hematoma, post operative fistula.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Patrick LACARIN 0473751195 placarin@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Nicolas BOURDEL         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Laboratoire SERB
Association GEGO
Investigators
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Principal Investigator: Nicolas BOURDEL University Hospital, Clermont-Ferrand

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03080558     History of Changes
Other Study ID Numbers: CHU-305
2016-002773-35 ( Other Identifier: 2016-002773-35 )
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
Indocyanine green fluorescence
Rectal vascularisation
Vaginal vascularisation
Laparoscopic surgery
Rectal shaving
Recto vaginal node
Deep Endometriosis

Additional relevant MeSH terms:
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Endometriosis
Neovascularization, Pathologic
Genital Diseases, Female
Metaplasia
Pathologic Processes