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HYSTINDO_Study of the vascularization of the vaginal slice after total laparoscopic hysterectomy, using indocyanine green injection. Prospective feasibility study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511467-28-00
Acronym
AOI 2023 CHAUVET
Enrollment
90
Registered
2024-07-19
Start date
2024-09-20
Completion date
Unknown
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

total hysterectomy

Brief summary

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.

Detailed description

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, Objective measurements of fluorescence and the surgeon's assessment (Likert scale), 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, 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, The vascularization of the vaginal slice defined by a fluorescence intensity value Fmax-Fmin on the graph according to patient characteristics, 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)., 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)., 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)., 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

Interventions

Sponsors

University Hospital Of Clermont-Ferrand
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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, Objective measurements of fluorescence and the surgeon's assessment (Likert scale), 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, 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, The vascularization of the vaginal slice defined by a fluorescence intensity value Fmax-Fmin on the graph according to patient char

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026