Using INDOcyanine Green to Analyse Ovarian Vascularization After Ovarian Laparoscopic CYStectomy

NCT04355312 | Completed

• 2 other identifiers: AOI 2019 GREMEAU2019-001966-14
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cysts; Endometriosis; Fertility

Keywords

Laparoscopic Ovarian Cystectomy; Indocyanine Green to study ovarian vascularization; Fertility

Outcome Measures

Primary Outcomes (1)

• 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.

  Inoperative

Secondary Outcomes (11)

• METAMORPH Score

  In immediate postoperative

• Rate of Side Effects

  In per and immediate postoperative

• Added time

  Immediate post operativ

• AMH dosage

  Preoperatively

• AMH dosage

  Month 6

Study Arms (1)

Kysindo

EXPERIMENTAL

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.

Diagnostic Test: Use of Indocyanine Green in laparoscopic ovarian cystectomy

Interventions

Use of Indocyanine Green in laparoscopic ovarian cystectomy DIAGNOSTIC_TEST

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.

Kysindo

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Centre Imagerie Cellulaire Santé, Faculté Médecine et Pharmacie, CLERMONT FERRAND: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Ovarian Cysts; Endometriosis

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Anne-Sophie GREMEAU

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: June 15, 2020
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

FR (1)