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

Recruiting
Conditions
Patients with bowel endometriosis
Registration Number
NL-OMON25350
Lead Sponsor
Haaglanden Medical Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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