Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06608082
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Study of the Vascularization of the Vaginal Slice After Total Laparoscopic Hysterectomy Using Indocyanine Green Injection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study of the Vascularization of the Vaginal Slice After Total Laparoscopic Hysterectomy Using Indocyanine Green Injection Prospective Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HYSTINDO
Brief Summary:
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
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
Detailed Description:
To perform this study the patient will undergo a preoperative consultation with a senior surgeon and an anesthetist from the department to schedule the surgical procedure and discuss potential inclusion in the protocol
Day before the surgery The patient will give an informed and written consent and will be enrolled in the study
The day of the intervention The planned surgical procedure will be performed as initially scheduled by the surgeon total hysterectomy The difference from standard care is that during the intraoperative period at the end of the procedure the patient will receive a diluted bolus of indocyanine green 25 mg in 10 ml of 5 glucose solution at a dose of 02 mgkg Subsequently the laparoscopic camera system will be switched to an infrared camera system to visualize intra-abdominal fluorescence using the trocars used during the surgery A video recording sequence of the vaginal cuff lasting two to five minutes starting from the moment of the indocyanine green injection will be collected by the investigator The collected images will be analyzed using the TRACKER software Douglas Brown Open Source Physics Boston MA USA
Postoperative period A postoperative consultation will take place between 3 and 8 weeks after the surgery with one of the senior physicians from the department Postoperative progress and early complications dehiscence cuff infection abscess or hematoma will be documented along with anatomopathological examination data and the final diagnosis
The postoperative follow-up will remain consistent with the usual protocol following this procedure The protocol does not involve any additional visits thus no potential extra coast
Day before the surgery The patient will give an informed and written consent and will be enrolled in the study
The day of the intervention The planned surgical procedure will be performed as initially scheduled by the surgeon total hysterectomy The difference from standard care is that during the intraoperative period at the end of the procedure the patient will receive a diluted bolus of indocyanine green 25 mg in 10 ml of 5 glucose solution at a dose of 02 mgkg Subsequently the laparoscopic camera system will be switched to an infrared camera system to visualize intra-abdominal fluorescence using the trocars used during the surgery A video recording sequence of the vaginal cuff lasting two to five minutes starting from the moment of the indocyanine green injection will be collected by the investigator The collected images will be analyzed using the TRACKER software Douglas Brown Open Source Physics Boston MA USA
Postoperative period A postoperative consultation will take place between 3 and 8 weeks after the surgery with one of the senior physicians from the department Postoperative progress and early complications dehiscence cuff infection abscess or hematoma will be documented along with anatomopathological examination data and the final diagnosis
The postoperative follow-up will remain consistent with the usual protocol following this procedure The protocol does not involve any additional visits thus no potential extra coast
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None