HysterectomyHYSTINDONCT06608082
Study of the Vascularization of the Vaginal Slice After Total Laparoscopic Hysterectomy, Using Indocyanine Green Injection.
A study testing indocyanine green injected intravenously in people with Hysterectomy and Vascularization, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterectomy, Vascularization, Complication of Surgical Procedure
- What is being tested?
- indocyanine green injected intravenously
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Procedure requiring the use of indocyanine green.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre, 04 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr
Pauline CHAUVET
About this study
Official title: Study of the Vascularization of the Vaginal Slice After Total Laparoscopic Hysterectomy, Using Indocyanine Green Injection. Prospective Feasibility Study
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.
Read more
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.
Read the 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 0.2 mg/kg. 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.
- Being tested
- indocyanine green injected intravenously
- Keywords
- indocyanine green, laparoscopic hysterectomy, Post-operative complications of hysterectomy, TRACKER software, imaging technique
- Medical subject headings
- Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indocyanine green injected intravenouslyDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Totale hysterectomy with indocyanine green and fluorescence intensity analysis | Other | Patient scheduled to undergo total hysterectomy through a surgically accessible laparoscopic procedure.
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. The collected images will be analyzed using the TRACKER software in order to assess intraoperative vascularization of the area (fluorescence intensity value different from 0). Receives: Diagnostic Test: indocyanine green injected intravenously |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 months
Secondary outcomes (9)
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).
Measured: 2 months
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.
Measured: through study completion, an average of 1 year
Evaluate the immediate or delayed tolerance of indocyanine green.
Side effects and occurrence of adverse events related to the injection of indocyanine green.
Measured: through study completion, an average of 1 year
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.
Measured: 2 months
Compare the vascularization of the vaginal cuff to patient characteristics.
Patient characteristics :IMC, age, tabacco consumption (yes/no), ASA score, gestation/parity, medical and surgical history, comorbidities, surgical indication, preoperative imaging (echography and/or MRI (yes/no) and conclusion), concomitant treatment, sexual activity (yes/no).
Measured: 2 months
Compare the vascularization of the vaginal cuff to Surgical technique
Surgical technique : instrument and coagulation mode, energy type, suture type, thread type
Measured: 2 months
Compare the vascularization of the vaginal cuff to Type of camera
Type of camera : SPIES, RUBINA, and FIREFLY systems
Measured: 2 months
Compare the vascularization of the vaginal cuff to Post-operative complications
Post-operative complications : bleeding, fever, biological inflammatory syndrome, pain, early post-operative abscess, hemoperitoneum, hematoma, infection/abscess, fistula
Measured: 2 months
Compare the vascularization of the vaginal cuff to State of the vaginal cuff
State of the vaginal cuff : Presence of visible sutures, On speculum examination : complete healing, ongoing healing, presence of dehiscence (size, time of occurrence) or evisceration and On vaginal palpation : presence or absence of dehiscence (size, time of occurence)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start21 Sep 2024 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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). This is a prospective feasibility study
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608082
- Sponsor's protocol ID
- AOI 2023 CHAUVET
- Acronym
- HYSTINDO
- Status last verified
- Sep 2024
- First submitted
- 23 Aug 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Vascularization of the Vaginal Slice After Total Laparoscopic Hysterectomy, Using Indocyanine Green Injection. Prospective Feasibility Study
- ClinicalTrials.gov ID
- NCT06608082
- Acronym / sponsor ID
- HYSTINDO / AOI 2023 CHAUVET
- Keywords
- indocyanine green, laparoscopic hysterectomy, Post-operative complications of hysterectomy, TRACKER software, imaging technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 21 Sep 2024 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 0.2 mg/kg. 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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). This is a prospective feasibility study
| Arm | Type | Receives |
|---|---|---|
| Totale hysterectomy with indocyanine green and fluorescence intensity analysis | Other | Diagnostic Test: indocyanine green injected intravenouslyPatient scheduled to undergo total hysterectomy through a surgically accessible laparoscopic procedure. 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. The collected images will be analyzed using the TRACKER software in order to assess intraoperative vascularization of the area (fluorescence intensity value different from 0). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- Procedure requiring the use of indocyanine green.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indocyanine green injected intravenouslyDuring 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. | Diagnostic test | Totale hysterectomy with indocyanine green and fluorescence intensity analysis |
Primary outcome
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).
Time frame: 2 months
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).
9 secondary outcomes
Examine the different parameters derived from the perfusion curve.
Time frame: 2 months
Compare the objective fluorescence measurements to the surgeon's assessment.
Time frame: through study completion, an average of 1 year
Evaluate the immediate or delayed tolerance of indocyanine green.
Time frame: through study completion, an average of 1 year
Assess the additional time added to the total operative duration by the protocol.
Time frame: 2 months
Compare the vascularization of the vaginal cuff to patient characteristics.
Time frame: 2 months
Compare the vascularization of the vaginal cuff to Surgical technique
Time frame: 2 months
Compare the vascularization of the vaginal cuff to Type of camera
Time frame: 2 months
Compare the vascularization of the vaginal cuff to Post-operative complications
Time frame: 2 months
Compare the vascularization of the vaginal cuff to State of the vaginal cuff
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing indocyanine green injected intravenously in people with Hysterectomy and Vascularization, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+33 4 73 75 11 95, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.