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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43974
Enrollment
20
Registered
2015-12-22
Start date
2016-02-02
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appearance of endometrial tissue outside the womb Endometriosis

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 two times the max normal value)

Design outcomes

Primary

MeasureTime frame
To evaluate the sensitivity and specificity of Narrow Band Imaging, near-infrared imaging with ICG and 3D-laparoscopy compared to conventional white light laparoscopic imaging. To evaluate if more endometriosis lesions are found with 3D, NBI and ICG compared to conventional white light laparoscopy.

Secondary

MeasureTime frame
-Descriptive analysis of the by endometriosis affected ovaries and intestines -Use of hormonal therapy -Use of pain medication -Operating time -Blood loss -(Serious) adverse events

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)