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Using INDOcyanine Green to Analyse Ovarian Vascularization After Ovarian Laparoscopic CYStectomy (KYSINDO)

Primary Purpose

Ovarian Cysts, Endometriosis, Fertility

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Use of Indocyanine Green in laparoscopic ovarian cystectomy
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Cysts focused on measuring Laparoscopic Ovarian Cystectomy, Indocyanine Green to study ovarian vascularization, Fertility

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • An adult woman of childbearing potential who has a desire for short-term pregnancy, under the age of 42, to undergo laparoscopic accessible surgical treatment (<10 cm) for a benign organic ovarian cyst (serous, mucinous, dermoid or endometriotic) whose diagnosis was made on imaging (ultrasound or MRI).
  • Patient able to provide informed consent to her participation in the study.
  • Patient covered by the " Sécurité Social " insurance system.

Exclusion Criteria:

  • Adult patient under protection, tutorship or curatorship.
  • Refusal of the patient or poor understanding of the French language.
  • Known allergy to iodine.
  • Current pregnancy or breastfeeding

Sites / Locations

  • CHU de Clermont-Ferrand

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Kysindo

Arm Description

Group of 45 patients with short-term desire for pregnancy who will undergo laparoscopic ovarian cystectomy with use of indocyanine green. Evaluation of the ovarian reserve preoperatively and longitudinal cohort follow-up after surgery at 6 months and 12 months. Analysis by a new imaging technique.

Outcomes

Primary Outcome Measures

Fluorescence uptake or not at the area of cystectomy (binary criterion)
A fluorescence score based on a Likert scale will be used. The presence of fluorescence will correspond to a success, defined by a value on the scale strictly greater than 0. The absence of fluorescence will be a failure, defined as equal to 0. The judgment criterion will therefore be binary (fluorescence uptake or no at the area of cystectomy), allowing the feasibility judgement.

Secondary Outcome Measures

METAMORPH Score
Automatic and objective allocation by the METAMORPH software of a raw score according to the fluorescence visualized.
Rate of Side Effects
Accounting for side effects and the occurrence of post-operative complications related to the injection of Indocyanine green.
Added time
Estimation of the protocol-related time added to the total operating time.
AMH dosage
Evaluation of the ovarian reserve biological by AMH dosage in comparison of the fluorescence scores. Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
AMH dosage
Evaluation of the ovarian reserve biological by AMH dosage in comparison of the fluorescence scores. Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
AMH dosage
Evaluation of the ovarian reserve biological by AMH dosage in comparison of the fluorescence scores. Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Evaluation of the ovarian reserve by ultrasound by CFA
Evaluation of the ovarian reserve biological by by ultrasound by CFA in comparison of the fluorescence scores. Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Evaluation of the ovarian reserve by ultrasound by CFA
Evaluation of the ovarian reserve biological by by ultrasound by CFA in comparison of the fluorescence scores. Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Evaluation of the ovarian reserve by ultrasound by CFA
Evaluation of the ovarian reserve biological by by ultrasound by CFA in comparison of the fluorescence scores. Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Number of Participants with Pregnancy
Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Number of Participants with Pregnancy
Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.

Full Information

First Posted
April 17, 2020
Last Updated
January 13, 2023
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Centre Imagerie Cellulaire Santé, Faculté Médecine et Pharmacie, CLERMONT FERRAND
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1. Study Identification

Unique Protocol Identification Number
NCT04355312
Brief Title
Using INDOcyanine Green to Analyse Ovarian Vascularization After Ovarian Laparoscopic CYStectomy
Acronym
KYSINDO
Official Title
Using INDOcyanine Green to Analyse Ovarian Vascularization After Ovarian Laparoscopic CYStectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
December 12, 2022 (Actual)
Study Completion Date
December 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Centre Imagerie Cellulaire Santé, Faculté Médecine et Pharmacie, CLERMONT FERRAND

4. Oversight

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

5. Study Description

Brief Summary
To evaluate the feasibility of using Indocyanine Green in the laparoscopic surgical treatment of benign organic ovarian cysts (dermoid, serous, mucinous and endometriotic) in patients with a short-term desire for pregnancy. The use of Indocyanine Green during this surgery could allow early evaluation of the absence of alteration of the underlying ovary by the cystectomy. To do so, the fluorescence scores (indocyanine green staining) need to be compared to the ovarian reserve of the patient, previously verified intraoperatively and postoperatively at M6 and M12, these scores being determined according to the vascularization visualized in laparoscopy and established both by a double visual notation (Likert scale) and by a computer software (METAMORPH) objective notation. This procedure would, in patients with fertility disorders or wishing for pregnancy in the short run, reassure them about their reproductive potential immediately after the intervention. In the event of poor staining, if correlated by a decrease in ovarian reserve, the concerned patients could be referred to a MPA treatment facility much earlier in the postoperative period or, if no desire for immediate pregnancy, towards fertility preservation methods.
Detailed Description
The study will be open to any patient meeting the inclusion / exclusion criteria, scheduled for intraperitoneal cystectomy or cyst destruction using Plasmajet, corresponding to a benign organic cyst requiring surgical treatment according to current recommendations. It will proceed as follows: Recruitment of patients during the preoperative consultation. The information form will be given to the patient. The day before the intervention: Inclusion proposed to the patient after re-explanation of the objectives and the progress of the study, submission of the consent form for the patient to sign. Realization of an ultrasound with count of antral follicles, and description of the ovarian cyst (size, aspect, IOTA criteria). Performing a blood test with AMH measurement to assess the preoperative ovarian reserve. The day of the intervention: Intraoperative, injection at the end of the procedure of a bolus of indocyanine green intravenously. Studied through an infrared camera system - the SPIES system (KARL STORZ GmbH & Co. KG, Tuttlingen, Germany) - fluorescence within the ovary will bring out the vascularization of the area of cystectomy or destruction of the cyst. Evaluation of the degree of fluorescence (between 0 and 4, on the model of a Likert scale) carried out at the area of cystectomy or destruction of the cyst. Then, the second evaluation technique using the METAMORPH software will assign a raw and objective score according to the fluorescence visualized. The 2 evaluation results will be compared with each other. Postoperatively: there will be no special clinical or biological monitoring. If undesirable effects related to Indocyanine Green occur, they will be noted. After discharge, as part of her standard follow-up for short-term desire for pregnancy: she will have a postoperative consultation planned 1 month after the intervention, followed by examination at 6 months and 12 months with an ultrasound for evaluation CFA and blood work with AMH. Any natural pregnancy will be noted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cysts, Endometriosis, Fertility
Keywords
Laparoscopic Ovarian Cystectomy, Indocyanine Green to study ovarian vascularization, Fertility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kysindo
Arm Type
Experimental
Arm Description
Group of 45 patients with short-term desire for pregnancy who will undergo laparoscopic ovarian cystectomy with use of indocyanine green. Evaluation of the ovarian reserve preoperatively and longitudinal cohort follow-up after surgery at 6 months and 12 months. Analysis by a new imaging technique.
Intervention Type
Diagnostic Test
Intervention Name(s)
Use of Indocyanine Green in laparoscopic ovarian cystectomy
Intervention Description
During intraperitoneal cystectomy or Plasmajet destruction of the cyst, as a benign organic cyst requiring surgical treatment, peroperatively, at the end of the cystectomy procedure, injection by the anesthetist on a peripheral venous route of a bolus of Indocyanine green diluted 0.2mg / kg. Installation of the SPIES camera system (KARL STORZ GmbH & Co.KG, Tuttlingen, Germany). Evaluation of the degree of fluorescence at the location of cystectomy or destruction of the cyst. A fluorescence score between 0 and 4 (on the model of a Likert scale) will be used for the evaluation of fluorescence. A second reading of the Likert scale results will be carried out by a second inspector so that the score is as objective as possible. Then, second evaluation technique realized by the METAMORPH software, which will assign a raw and objective score according to the fluorescence visualized.
Primary Outcome Measure Information:
Title
Fluorescence uptake or not at the area of cystectomy (binary criterion)
Description
A fluorescence score based on a Likert scale will be used. The presence of fluorescence will correspond to a success, defined by a value on the scale strictly greater than 0. The absence of fluorescence will be a failure, defined as equal to 0. The judgment criterion will therefore be binary (fluorescence uptake or no at the area of cystectomy), allowing the feasibility judgement.
Time Frame
Inoperative
Secondary Outcome Measure Information:
Title
METAMORPH Score
Description
Automatic and objective allocation by the METAMORPH software of a raw score according to the fluorescence visualized.
Time Frame
In immediate postoperative
Title
Rate of Side Effects
Description
Accounting for side effects and the occurrence of post-operative complications related to the injection of Indocyanine green.
Time Frame
In per and immediate postoperative
Title
Added time
Description
Estimation of the protocol-related time added to the total operating time.
Time Frame
Immediate post operativ
Title
AMH dosage
Description
Evaluation of the ovarian reserve biological by AMH dosage in comparison of the fluorescence scores. Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Time Frame
Preoperatively
Title
AMH dosage
Description
Evaluation of the ovarian reserve biological by AMH dosage in comparison of the fluorescence scores. Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Time Frame
Month 6
Title
AMH dosage
Description
Evaluation of the ovarian reserve biological by AMH dosage in comparison of the fluorescence scores. Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Time Frame
Month 12
Title
Evaluation of the ovarian reserve by ultrasound by CFA
Description
Evaluation of the ovarian reserve biological by by ultrasound by CFA in comparison of the fluorescence scores. Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Time Frame
Preoperatively
Title
Evaluation of the ovarian reserve by ultrasound by CFA
Description
Evaluation of the ovarian reserve biological by by ultrasound by CFA in comparison of the fluorescence scores. Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Time Frame
Month 6
Title
Evaluation of the ovarian reserve by ultrasound by CFA
Description
Evaluation of the ovarian reserve biological by by ultrasound by CFA in comparison of the fluorescence scores. Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Time Frame
Month 12
Title
Number of Participants with Pregnancy
Description
Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Time Frame
Month 6
Title
Number of Participants with Pregnancy
Description
Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Time Frame
Month 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: An adult woman of childbearing potential who has a desire for short-term pregnancy, under the age of 42, to undergo laparoscopic accessible surgical treatment (<10 cm) for a benign organic ovarian cyst (serous, mucinous, dermoid or endometriotic) whose diagnosis was made on imaging (ultrasound or MRI). Patient able to provide informed consent to her participation in the study. Patient covered by the " Sécurité Social " insurance system. Exclusion Criteria: Adult patient under protection, tutorship or curatorship. Refusal of the patient or poor understanding of the French language. Known allergy to iodine. Current pregnancy or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Sophie GREMEAU
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Using INDOcyanine Green to Analyse Ovarian Vascularization After Ovarian Laparoscopic CYStectomy

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