The primary objective is to assess the feasibility of intravenous injection of ICG to detect the border between healthy - and therefore fluorescent - bowel versus endometriosis.
ID
Source
Brief title
Condition
- Menstrual cycle and uterine bleeding disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
The distinction between endometriotic tissue and healthy tissue is difficult.
Removal of bowel endometriosis can be done via shaving, discoid resection or
segmental resection. While shaving results in the least complications,
segmental resection results in the lowest recurrence rates. One could
potentially use shaving for more patients, with more complete resection, if
endometriosis visibility is optimized. Fluorescence with indocyanine green
could be used for this purpose in bowel endometriosis, as the bowel is highly
vascularized and therefore fluorescent, compared to the fibrotic endometriotic
nodule.
Study objective
The primary objective is to assess the feasibility of intravenous injection of
ICG to detect the border between healthy - and therefore fluorescent - bowel
versus endometriosis.
Study design
Pilot study in one centre, with 15 patients.
Intervention
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.
Study burden and risks
The burden for patients is low. No extra visits are necessary for this study.
Moreover no extra blood samples, physical examinations, questionnaires or other
tests will take place.
The non-investigational product (ICG) is safely used for over 60 years for
multiple indications (including the one in this study, tissue perfusion). Only
mild allergic reactions have been seen. Patients with known a known allergic
reaction to ICG or a substance related to ICG are excluded. Conventional care
is not altered by the study.
Bronovolaan 5
Den Haag 2597 AX
NL
Bronovolaan 5
Den Haag 2597 AX
NL
Listed location countries
Age
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
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL78266.058.21 |
| OMON | NL-OMON25350 |