Using a fluorescent dye (INDOcyanine green) to analyse ovarian vascularization after surgery for ovarian cysts.

Using INDOcyanine green to analyse ovarian vascularization after ovarian laparoscopic CYStectomy, Diagnostic study of feasibility. - KYSINDO

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001966-14-FR

Enrollment

Registered

2020-02-25

Start date

2020-04-29

Completion date

Unknown

Last updated

2020-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Trade Name: INFRACYANINE 25 mg/10 ml, poudre et solvant pour solution injectable Pharmaceutical Form: Powder and solvent for solution for injection

Eligibility

Sex/Gender

All

Inclusion 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 (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: -Analyse the vascularization at the area of cystectomy or destruction of the cyst, using indocyanine green inoperative. Comparison of 2 techniques (Likert scale and METAMORPH software) -Accounting for side effects and the occurrence of post-operative complications related to the injection of Indocyanine green. -Estimation of the protocol-related time added to the total operating time. -Evaluation of the ovarian reserve in comparison of the vascularization at the area of cystectomy. -Evaluation of differences of vascularization at the area of cystectomy between different types of surgery ant different types of cysts;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: Inoperative	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: -Analyse the vascularization at the area of cystectomy or destruction of the cyst, using indocyanine green inoperative. Comparison of 2 techniques (Likert scale and METAMORPH software) -Accounting for side effects and the occurrence of post-operative complications related to the injection of Indocyanine green. -Estimation of the protocol-related time added to the total operating time. -Evaluation of the ovarian reserve in comparison of the vascularization at the area of cystectomy. -Evaluation of differences of vascularization at the area of cystectomy between different types of surgery ant different types of cysts;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: Inoperative

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Secondary

Measure	Time frame
Secondary end point(s): -Automatic and objective allocation by the METAMORPH software of a raw score according to the fluorescence visualized. Comparison to the score of Likert scale -Accounting for side effects and the occurrence of post-operative complications related to the injection of Indocyanine green. -Estimation of the protocol-related time added to the total operating time. -Evaluation of the ovarian reserve (biological by AMH and 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. -Comparison of the fluorescence scores (Likert and METAMORPH) regarding type of cysts and type of surgery ;Timepoint(s) of evaluation of this end point: -In immediate postoperative -In per and immediate postoperative -Immediate post operative -Preoperatively then at 6 and 12 months post operative. -Postopérative	—

Measure

Time frame

Secondary end point(s): -Automatic and objective allocation by the METAMORPH software of a raw score according to the fluorescence visualized. Comparison to the score of Likert scale -Accounting for side effects and the occurrence of post-operative complications related to the injection of Indocyanine green. -Estimation of the protocol-related time added to the total operating time. -Evaluation of the ovarian reserve (biological by AMH and 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. -Comparison of the fluorescence scores (Likert and METAMORPH) regarding type of cysts and type of surgery ;Timepoint(s) of evaluation of this end point: -In immediate postoperative -In per and immediate postoperative -Immediate post operative -Preoperatively then at 6 and 12 months post operative. -Postopérative

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Countries

France

Contacts

Public ContactLise LACLAUTRE

CHU de Clermont-Ferrand

promo_interne_drci@chu-clermontferrand.fr+33473754963

Outcome results