Indocyanine Green and Rectosigmoid Endometriosis (vincendo)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Unknown

Conditions: Bowel Endometriosis; Endometriosis, Rectum

Treatments: Diagnostic Test: assessment of rectosigmoid during laparoscopy; Diagnostic Test: assessment of rectosigmoid perfusion during robot-assisted laparoscopy; Diagnostic Test: assessment of bowel symptoms before surgery; Diagnostic Test: follow up and assessment of bowel symptoms after surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03532074

290/2017/O/Sper

Details and patient eligibility

About

Indocyanine green is a fluorescent dye used for the intraoperative evaluation of tissue perfusion.

The aim of this study is to evaluate a possible correlation between rectosigmoid vascularization and surgical and clinical data including pre and post-operative bowel symptoms in patients needing surgery for rectosigmoid endometriosis.

Full description

Patients with symptomatic rectosigmoid endometriosis requiring laparoscopic surgery are included in the study.

Before surgery, bowel symptoms are assessed using validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index).

Indocyanine green is administered through peripheral line. A near-infrared (NIR) camera-head enables real-time direct visualization of bowel perfusion before and after the removal of the rectosigmoid nodule. Rectosigmoid tract perfusion is assessed before and after the removal of the nodule. To estimate the vascularization, a scale with a score between 0 and 4 is used.

After complete removal of rectosigmoid nodule, the post-operative follow-up will be the same as usual after intestinal endometriosis surgery. Postoperative bowel symptoms are evaluated using the same questionnaires.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of deep endometriosis based on clinical and transvaginal/transabdominal ultrasound examinations and, when necessary, magnetic resonance
• Patients with indication for removal of endometriosic lesions by laparoscopic surgery
• Obtaining Informed Consent

Exclusion criteria

• Known or suspected allergy to iodine
• Previous rectal surgery
• History of active pelvic infection
• Intra-abdominal or pelvic malignancy
• Pelvic radiation therapy
• Hyperthyroidism
• Liver dysfunction
• Serum creatinine > 2.0 mg/dL

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

laparoscopic approach

Other group

Description:

assessment of bowel symptoms before surgery; assessment of rectosigmoid perfusion using indocyanine green; removal of rectosigmoid endometriosis nodule using a laparoscopic approach; follow up and assessment of bowel symptoms after surgery

Treatment:

Diagnostic Test: assessment of rectosigmoid during laparoscopy

Diagnostic Test: follow up and assessment of bowel symptoms after surgery

Diagnostic Test: assessment of bowel symptoms before surgery

robot-assisted approach

Other group

Description:

assessment of bowel symptoms before surgery; assessment of rectosigmoid perfusion using indocyanine green; removal of rectosigmoid endometriosis nodule using a robot-assisted approach; follow up and assessment of bowel symptoms after surgery

Treatment:

Diagnostic Test: assessment of rectosigmoid perfusion during robot-assisted laparoscopy

Diagnostic Test: follow up and assessment of bowel symptoms after surgery

Diagnostic Test: assessment of bowel symptoms before surgery