INDOCYANINE GREEN for Total hysterectomy

Inclusion criteria

• {"criterion_text":"- Adult patient"}
• {"criterion_text":"- Patient requiring hysterectomy by surgical treatment accessible by laparoscopy"}

Exclusion criteria

• {"criterion_text":"- Protected patient, under guardianship, curatorship or legal protection"}
• {"criterion_text":"- Patient refusal or poor understanding of the French language"}
• {"criterion_text":"- Known allergy to iodine"}
• {"criterion_text":"- Current pregnancy and breastfeeding"}
• {"criterion_text":"- Intervention requiring the use of indocyanine green"}

Primary endpoints

• {"endpoint_text":"- Evolution of green levels in an area of ​​interest, from which a time-fluorescence curve can be obtained. The presence of fluorescence will be defined by the fluorescence intensity value Fmax-Fmin.","definition_or_measurement_approach":"Presence of fluorescence defined by the fluorescence intensity value Fmax-Fmin derived from a time–fluorescence (perfusion) curve obtained from the area of interest."}

Secondary endpoints

• {"endpoint_text":"- The different parameters from the perfusion curve: minimum fluorescence intensity Fmin, fluorescence intensity Fmax, the difference in fluorescence intensity Fmax-min, the slope of the fluorescence intensity, the time ratio TR","definition_or_measurement_approach":"Parameters derived from the perfusion (time–fluorescence) curve: Fmin, Fmax, Fmax-min, slope of fluorescence intensity, and time ratio (TR)."}
• {"endpoint_text":"- Objective measurements of fluorescence and the surgeon's assessment (Likert scale)","definition_or_measurement_approach":"Objective fluorescence measurements (quantitative) will be compared with surgeon assessment recorded on a Likert scale."}
• {"endpoint_text":"- From the injection of indocyanine green during the procedure until the post-operative consultation, the side effects and the occurrence of adverse events linked to the injection of indocyanine green will be noted","definition_or_measurement_approach":"Recording of side effects and adverse events related to indocyanine green from injection during the procedure through the post-operative consultation."}
• {"endpoint_text":"- The time added by the protocol to the total operating time. The duration of the phase corresponding to the protocol will be equal to the time between the injection of indocyanine green and the stopping of video recording in minutes. The total operating time will be equal to the time between the incision time and the closing time in minutes","definition_or_measurement_approach":"Protocol phase time = minutes between indocyanine green injection and stop of video recording. Total operative time = minutes between incision and closure. Difference quantifies time added by protocol."}
• {"endpoint_text":"- The vascularization of the vaginal slice defined by a fluorescence intensity value Fmax-Fmin on the graph according to patient characteristics","definition_or_measurement_approach":"Vascularization measured as Fmax-Fmin on fluorescence graph; analyses performed stratified by patient characteristics."}
• {"endpoint_text":"- The vascularization of the vaginal slice defined by a fluorescence intensity value Fmax-Fmin on the graph according to surgical technique (coagulation tool and method, type of energy, type of suture, type of thread).","definition_or_measurement_approach":"Vascularization measured as Fmax-Fmin on fluorescence graph; analyses compared across surgical technique variables (coagulation tool/method, energy type, suture type, thread type)."}
• {"endpoint_text":"- The vascularization of the vaginal slice defined by a fluorescence intensity value Fmax-Fmin on the graph according to the type of camera (SPIES, RUBINA and FIREFLY systems).","definition_or_measurement_approach":"Vascularization measured as Fmax-Fmin on fluorescence graph; comparisons made by camera system (SPIES, RUBINA, FIREFLY)."}
• {"endpoint_text":"- The vascularization of the vaginal slice defined by a fluorescence intensity value Fmax-Fmin on the graph according to post-operative complications (bleeding, fever, biological inflammatory syndrome, pain, early post-operative abscess, hemoperitoneum, hematoma, infection/abscess, fistula).","definition_or_measurement_approach":"Vascularization measured as Fmax-Fmin on fluorescence graph; analyses by presence/absence and type of post-operative complications listed."}
• {"endpoint_text":"- The vascularization of the vaginal slice defined by a fluorescence intensity value Fmax-Fmin on the graph according to the condition of the vaginal fundus scar","definition_or_measurement_approach":"Vascularization measured as Fmax-Fmin on fluorescence graph; analyses stratified by condition of the vaginal fundus scar."}

France

Earliest CTIS Part Ii Submission Date

03-06-2024

Latest Decision Or Authorization Date

04-09-2025

Processing Time Days

458

Number Of Sites

1

Number Of Participants

90

Primary sponsor

Full Name

University Hospital Of Clermont-Ferrand

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France