CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
NCT Number: NCT04355312
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.
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Notify Me18 year–42 year
Female
Interventional
Not applicable
Clermont-Ferrand, 63000, France
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:
Any natural pregnancy will be noted.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Inoperative
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: In immediate postoperative
Automatic and objective allocation by the METAMORPH software of a raw score according to the fluorescence visualized.
Time frame: In per and immediate postoperative
Accounting for side effects and the occurrence of post-operative complications related to the injection of Indocyanine green.
Time frame: Immediate post operativ
Estimation of the protocol-related time added to the total operating time.
Time frame: Preoperatively
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
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
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
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
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
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
Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
Time frame: Month 12
Study of natural fertility in the year following the cystectomy in the patients wishing for pregnancy.
University Hospital, Clermont-Ferrand
Other
Acronym: KYSINDO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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