Improved visualisation of endometriosis during laparoscopic treatment

Active, not recruiting

• Conditions: Endometriosis; MedDRA version: 18.1Level: PTClassification code 10014778Term: EndometriosisSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2015-000644-42-NL
• Lead Sponsor: VU University medical center (VUmc)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-04
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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-IV) confirmed by previous laparoscopy or likely to be present based on TVUS or MRI, including uni- or bilateral ovarian endometrioma.
• Regular preoperative work-up

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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 usage of indocyanin green injection
• Hyperthyroidism 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: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate feasibility as to which enhanced imaging technique has the best sensitivity in detecting peritoneal endometriosis, compared to conventional white light laparoscopy.;Secondary Objective: -Specificity<br>-Negative and positive predictive value<br>-Direct costs<br>-Usability<br>-Descriptive analysis of the by endometriosis affected ovaries and intestines.<br>-Occurrence of (serious) adverse events / patient safety<br>-Time of the procedure / operation time (minutes)<br>-Blood loss<br>-Difference in detection (staining) between superficial (peritoneal) endometriosis and deep endometriosis.;Primary end point(s): To evaluate the sensitivity of Narrow Band Imaging, near-infrared imaging with ICG and 3D-laparoscopy compared to conventional white light laparoscopic imaging. ;Timepoint(s) of evaluation of this end point: After pathological examination of all biopsies

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: After pathological examination of all biopsies;Secondary end point(s): - Specificity<br>- Negative and positive predictive value<br>- Descriptive analysis of the by endometriosis affected ovaries and intestines. <br>- Descriptive analysis of the difference in detection between superficial (peritoneal) endometriosis and deep endometriosis. <br>- Descriptive and quantitative analysis of the occurrence of (serious) adverse events.