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

Completed

Conditions: endometriosis
endometrium outside the uterus
10013326
10029903

Registration Number: NL-OMON49910

Lead Sponsor: Haaglanden Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in the borders between bowel endometriotic nodule and healthy<br /><br>bowel. These borders will be determined by using indocyanine green to visualize<br /><br>the healthy bowel, compared to determination with conventional white light.</p><br>

Secondary Outcome Measures

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