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

Primary Purpose

Deep Endometriosis, Recto Vaginal Node

Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Indocyanine green
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Endometriosis focused on measuring Indocyanine green fluorescence, Rectal vascularisation, Vaginal vascularisation, Laparoscopic surgery, Rectal shaving, Recto vaginal node, Deep Endometriosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

endometriosis recto vaginal node

Arm Description

Outcomes

Primary Outcome Measures

Per-operative evaluation of the rectum
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

Side effects after indocyanine green injection
Post operative complications
infections, abdominal abscess, abdominal hematoma, post operative fistula.

Full Information

First Posted
March 6, 2017
Last Updated
February 1, 2019
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Laboratoire SERB, Association GEGO
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1. Study Identification

Unique Protocol Identification Number
NCT03080558
Brief Title
Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving
Acronym
INDIE
Official Title
Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving, Using Indocyanine Green Injection. Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 6, 2017 (Actual)
Primary Completion Date
February 28, 2019 (Anticipated)
Study Completion Date
February 28, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Laboratoire SERB, Association GEGO

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Endometriosis, Recto Vaginal Node
Keywords
Indocyanine green fluorescence, Rectal vascularisation, Vaginal vascularisation, Laparoscopic surgery, Rectal shaving, Recto vaginal node, Deep Endometriosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
open
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
endometriosis recto vaginal node
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Indocyanine green
Intervention Description
Use of Indocyanine Green during Rectal shaving by laparoscopy.
Primary Outcome Measure Information:
Title
Per-operative evaluation of the rectum
Description
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
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
Side effects after indocyanine green injection
Time Frame
at day 1
Title
Post operative complications
Description
infections, abdominal abscess, abdominal hematoma, post operative fistula.
Time Frame
at day 1

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas BOURDEL
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Nicolas BOURDEL

12. IPD Sharing Statement

Citations:
PubMed Identifier
32646588
Citation
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.
Results Reference
derived
PubMed Identifier
29885885
Citation
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.
Results Reference
derived

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

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