Hysterectomy is one of the most common surgical procedures in gynecology, especially by laparoscopy. Post-operative complications of hysterectomy are numerous and their causes are poorly understood.
Indocyanine green is a fluorescent dye that, when exposed to infrared light, makes it possible to visualize the vascularization by fluorescence.
The project consists in studying the vascularization of the vaginal cuff after total laparoscopic hysterectomy using the injection of indocyanine green. This is a prospective feasibility study.
During the procedure, after performing the hysterectomy, indocyanine green will be injected intravenously into the patient. A fluorescence video of the vaginal cuff will be recorded. The fluorescence of the recorded images will be analyzed by fluorescence analysis software to obtain an objective value of fluorescence. The fluorescence values will be compared to the occurrence or absence of postoperative complications.
This is the first study using this imaging technique combined with indocyanine green in this surgery. This study will employ a novel objective sequential fluorescence analysis software that has already proven its effectiveness in digestive surgery. The sequential measurement of the change in fluorescence intensity visualized in the images of laparoscopy will enable the production of vaginal perfusion graphs using a video modeling tool such as the TRACKER software. This software measures the evolution of green levels in a region of interest, from which a time-fluorescence curve can be obtained. The presence of fluorescence will be defined by a fluorescence intensity value of Fmax-Fmin on the graph.
Adult patient
Patient scheduled to undergo total hysterectomy through a surgically accessible laparoscopic procedure.
Patiente capable of providing informed consent to participate in the study.
Patiente covered by the Social Security system.
Protected patient, under guardianship, curatorship or legal protection.
Patient's refusal or inadequate understanding of the French language.
Known allergy to iodine.
Ongoing pregnancy and breastfeeding.
Single group
indocyanine green injected intravenously
Diagnostic testDuring the procedure, after performing the hysterectomy, indocyanine green will be injected intravenously into the patient. A fluorescence video of the vaginal cuff will be recorded. The fluorescence of the recorded images will be analyzed by fluorescence analysis software to obtain an objective value of fluorescence.
Study the presence of indocyanine green in the vaginal cuff during the total laparoscopic hysterectomy, in order to assess intraoperative vascularization of the area (fluorescence intensity value different from 0).
An objective measurement of fluorescence will be employed. Sequential measurement of fluorescence intensity changes observed in the laparoscopy images will enable the creation of vaginal perfusion graphs using a video modeling tool like the TRACKER software (Douglas Brown, Open Source Physics, Boston MA, USA). This software tracks the evolution of green levels within a region of interest, from which a time-fluorescence curve can be derived. The presence of fluorescence will be defined by the fluorescence intensity value Fmax-Fmin. All procedures will be recorded and subsequently collected by the investigator. All collected images will undergo analysis using the TRACKER software (Douglas Brown, Open Source Physics, Boston MA, USA).
Examine the different parameters derived from the perfusion curve.
The different parameters derived from the perfusion curve: minimum fluorescence intensity (Fmin), maximum fluorescence intensity (Fmax), difference in fluorescence intensity (Fmax-min), slope of fluorescence intensity, time ratio (TR).
Compare the objective fluorescence measurements to the surgeon's assessment.
Objective fluorescence measurements and surgeon's assessment (Likert scale). The uptake of fluorescence in the vaginal cuff and its intensity will be evaluated by the surgeon during the procedure using a Likert scale. The presence of fluorescence will be defined by a score from 0 to 4. The obtained score will be compared to the objective measurements of the fluorescence curve.
Evaluate the immediate or delayed tolerance of indocyanine green.
Side effects and occurrence of adverse events related to the injection of indocyanine green.
Assess the additional time added to the total operative duration by the protocol.
The time added to the total operative duration by the protocol. The duration of the phase corresponding to the protocol will be equal to the time between the injection of indocyanine green and the cessation of video recording in minutes. The total operative duration will be equal to the time between the incision time and the closure time in minutes.
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