aparoscopic advanced Imaging Techniques in Endometriosis therapy: the LITE study. A pilot trial.

Completed

Conditions: Appearance of endometrial tissue outside the womb
Endometriosis
10034652
10013326
10029903

Registration Number: NL-OMON43974

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

-Oral and written informed consent
-Age 18 years and older
-Premenopausal women
-Elective laparoscopic treatment of endometriosis lesions by CO 2 laser/ bipolar diathermy or surgical excision.
-Presence of endometriosis (ASRM III-V) confirmed by previous laparoscopy or likely to be present based on TVUS or MRI, including uni- or bilateral ovarian endometrioma.
-Regular preoperative work-up

Exclusion Criteria

-Women who are legally or mentally incapable or unable to give informed consent
-Age younger than 18 years
-ASA (American Society of Anaesthesiologists) score higher than 3
-Woman who have had major open abdominal surgery
-Pregnancy
-Malignancy
-Iodine allergy
-Hypersensitivity reaction to prior indocyanine green injection
-Hyperthyoidism or autonomous thyroid adenoma
-Chronic kidney failure (eGFR<55)
-Chronic liver failure (ASAT, ALAT, AF and yGT > two times the max normal value)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the sensitivity and specificity of Narrow Band Imaging,<br /><br>near-infrared imaging with ICG and 3D-laparoscopy compared to conventional<br /><br>white light laparoscopic imaging.<br /><br>To evaluate if more endometriosis lesions are found with 3D, NBI and ICG<br /><br>compared to conventional white light laparoscopy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Descriptive analysis of the by endometriosis affected ovaries and intestines<br /><br>-Use of hormonal therapy<br /><br>-Use of pain medication<br /><br>-Operating time<br /><br>-Blood loss<br /><br>-(Serious) adverse events </p><br>