Intra-operative near-infrared fluorescence imaging of the bowel during endometriosis surgery with indocyanine green: a pilot study

Intra-operative near-infrared fluorescence imaging of the bowel during endometriosis surgery with indocyanine green: a pilot study - Intra-operative imaging endometriosis with ICG

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49910

Enrollment

Registered

2021-10-29

Start date

2022-02-12

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

endometriosis endometrium outside the uterus

Interventions

All patients will receive a repeated dose of 5 mg ICG at two moments: after visualization of the endometriotic bowel nodule and right before segmental resection.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Scheduled for laparoscopic removal of bowel endometriosis, by segment resection; 2. Patients aged over 18 years old; 3. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions; 4. Signed informed consent prior to any study-mandated procedure;

Exclusion criteria

Exclusion criteria: 1. Known allergy or history of adverse reaction to ICG, iodine or iodine dyes; 2. Severe liver insufficiency; 3. Hyperthyroidism or a benign thyroid tumour; 4. Pregnant or breastfeeding women; 5. Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives (following a detailed medical history and physical examination; 6. Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid; 7. Emergency surgery

Design outcomes

Primary

Measure	Time frame
The difference in the borders between bowel endometriotic nodule and healthy bowel. These borders will be determined by using indocyanine green to visualize the healthy bowel, compared to determination with conventional white light.	—

Secondary

Measure	Time frame
1. Assessment of the pathological, clinical and patient characteristics and correspondence to the non-fluorescent character of the endometriotic nodule. 2. The fluorescent difference between bowel and endometriotic nodule at 2 moments during surgery, measured intra-operatively by the surgeon and post-operatively by the researcher via operative images. 3. Assessment of potential added value of intra-operative visualization of endometriosis through a questionnaire for the surgeon	—

Measure

Time frame

1. Assessment of the pathological, clinical and patient characteristics and correspondence to the non-fluorescent character of the endometriotic nodule. 2. The fluorescent difference between bowel and endometriotic nodule at 2 moments during surgery, measured intra-operatively by the surgeon and post-operatively by the researcher via operative images. 3. Assessment of potential added value of intra-operative visualization of endometriosis through a questionnaire for the surgeon

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)