Using Indocyanine Green to Analyse Ovarian Vascularization after Ovarian Laparoscopic Cystectomy, Diagnostic Study of Feasibility.

Abstract

Study 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. Design Study Type: Interventional: based on a protocol - Follow up by a cohort. Study Model: Single Group: all participants receive the same intervention. Longitudinal cohort follow-up after surgery at 6 months and 12 months. Setting N/A. Patients or Participants Open to any patient meeting the inclusion / exclusion criteria. Number of subjects: 45. Interventions 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 on a peripheral venous route of a bolus of Indocyanine green diluted 0.2mg / kg. Installation of infrared camera system. Evaluation of the degree of fluorescence at the location of cystectomy or destruction of the cyst. Evaluation of the ovarian reserve preoperatively (ultrasound for evaluation AFC and blood work with AMH). Analysis by a new imaging technique. Measurements and Main Results 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. Preliminary Results: Feasibility: 100%, Likert's Average: 3,2/4, Metamorph: In progress. Conclusion The use of Indocyanine Green during this surgery could allow early evaluation of the absence of alteration of the underlying ovary by the cystectomy. Reassure them about their reproductive potential immediately after the intervention. 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. Study Type: Interventional: based on a protocol - Follow up by a cohort. Study Model: Single Group: all participants receive the same intervention. Longitudinal cohort follow-up after surgery at 6 months and 12 months. N/A. Open to any patient meeting the inclusion / exclusion criteria. Number of subjects: 45. 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 on a peripheral venous route of a bolus of Indocyanine green diluted 0.2mg / kg. Installation of infrared camera system. Evaluation of the degree of fluorescence at the location of cystectomy or destruction of the cyst. Evaluation of the ovarian reserve preoperatively (ultrasound for evaluation AFC and blood work with AMH). Analysis by a new imaging technique. 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. Preliminary Results: Feasibility: 100%, Likert's Average: 3,2/4, Metamorph: In progress. The use of Indocyanine Green during this surgery could allow early evaluation of the absence of alteration of the underlying ovary by the cystectomy. Reassure them about their reproductive potential immediately after the intervention.