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Study on Blood Flow in the Vaginal Area After Total Laparoscopic Hysterectomy Using Indocyanine Green for Patients Undergoing Hysterectomy

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the blood flow in the vaginal area after a surgical procedure called a total laparoscopic hysterectomy. This surgery involves the removal of the uterus using small incisions and a camera to guide the procedure. The study uses a special dye called indocyanine green, which is injected into the bloodstream to help visualize blood flow during the surgery. The purpose of the study is to evaluate how well blood is circulating in the area where the surgery was performed.

During the study, patients undergoing a total laparoscopic hysterectomy will receive an injection of indocyanine green. This dye helps the surgical team see how blood is flowing in the area of interest by using a special camera that detects the dye's fluorescence, or glow. The study will monitor the levels of this glow to understand the blood flow patterns. The procedure will be observed from the time of the dye injection until the post-operative consultation to note any side effects or adverse events related to the dye.

The study aims to gather information on how different factors, such as surgical techniques and patient characteristics, affect blood flow in the surgical area. This includes looking at the intensity of the fluorescence and how it changes over time. The study will also consider any complications that may arise after the surgery, such as bleeding or infection, and how these might relate to the blood flow observed during the procedure. The findings could help improve surgical techniques and patient outcomes in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. The study is for adult patients requiring a total hysterectomy through laparoscopic surgery.

  2. Step 2

    Preparation for surgery

    Before the surgery, preparation involves standard pre-operative procedures. This includes discussions about the use of indocyanine green, a dye used to study blood flow during the operation.

  3. Step 3

    Surgery and dye injection

    During the laparoscopic total hysterectomy, indocyanine green is injected intravenously. This helps in evaluating the blood flow in the area of interest, specifically the vaginal slice.

  4. Step 4

    Intraoperative evaluation

    The presence of the dye is monitored to assess the blood flow. This is done by measuring the fluorescence intensity, which helps in understanding the vascularization of the area.

  5. Step 5

    Post-operative monitoring

    After the surgery, monitoring continues to observe any side effects or adverse events related to the dye injection. This includes checking for complications such as bleeding or infection.

  6. Step 6

    Follow-up consultation

    A follow-up consultation is scheduled to review the outcomes of the surgery and the effects of the dye. This includes discussing any post-operative complications and the overall recovery process.

Who can join the trial?

3 criteria

  • The patient must be an adult.
  • The patient must need a hysterectomy, which is a surgery to remove the uterus, and it should be done using a method called laparoscopy. Laparoscopy is a type of surgery where small cuts are made, and a camera is used to help the surgeon see inside the body.
  • The patient must be female.

Who cannot join the trial?

3 criteria

  • Patients who have already had a total hysterectomy cannot participate. A total hysterectomy is a surgery where the uterus and cervix are completely removed.
  • Only female patients are eligible, so male patients cannot participate.
  • Patients who are considered part of a vulnerable population are not eligible. A vulnerable population includes groups who may have difficulty giving informed consent or are at higher risk of harm.
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Investigated drugs

Indocyanine Green is a dye used in this study to help visualize blood flow and vascularization. During the surgical procedure, it is injected to allow doctors to see how well blood is circulating in the area of the vaginal slice after a total laparoscopic hysterectomy. This helps in assessing the success of the surgery and ensuring that the tissue is receiving adequate blood supply.

What is already known about the treatment

Indocyanine Green – This medication is administered through an injection and is used during surgical procedures. It is currently being studied for its ability to help visualize blood flow and vascularization in tissues, particularly during a total laparoscopic hysterectomy. The main therapeutic indication is to assess the blood supply to the vaginal area during surgery. At the molecular level, indocyanine green works by binding to plasma proteins and emitting fluorescence when exposed to near-infrared light, allowing surgeons to see blood vessels clearly. It is classified as a diagnostic agent used in medical imaging.

Investigated diseases

Total Hysterectomy – Total hysterectomy is a surgical procedure that involves the complete removal of the uterus, including the cervix. This operation is typically performed to treat various conditions such as uterine fibroids, endometriosis, or uterine cancer. During the procedure, the uterus is detached from the ovaries, fallopian tubes, and upper vagina, as well as from the blood vessels and connective tissue that support it. The surgery can be performed through different methods, including abdominal, vaginal, or laparoscopic approaches. Recovery from a total hysterectomy can vary depending on the surgical technique used and the individual's overall health.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511467-28-00Protocol codeAOI 2023 CHAUVETEstimated enrolment90 patientsSponsorUniversity Hospital Of Clermont-Ferrand

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