Intraoperative Assessment of Bowel Perfusion Through Indocyanine Green in Women With Rectosigmoid Endometriosis and Its Correlation With Clinical and Surgical Data
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- correlation between bowel symptoms and rectosigmoid perfusion before the nodule removal
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Masking Description
OPEN
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
laparoscopic approach
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
Intervention: assessment of bowel symptoms before surgery (Diagnostic Test)
laparoscopic approach
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
Intervention: assessment of rectosigmoid during laparoscopy (Diagnostic Test)
laparoscopic approach
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
Intervention: follow up and assessment of bowel symptoms after surgery (Diagnostic Test)
robot-assisted approach
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
Intervention: assessment of bowel symptoms before surgery (Diagnostic Test)
robot-assisted approach
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
Intervention: follow up and assessment of bowel symptoms after surgery (Diagnostic Test)
robot-assisted approach
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
Intervention: assessment of rectosigmoid perfusion during robot-assisted laparoscopy (Diagnostic Test)
Outcomes
Primary Outcomes
correlation between bowel symptoms and rectosigmoid perfusion before the nodule removal
Time Frame: intraoperative
comparison between bowel symptoms, assessed through validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) and rectosigmoid perfusion, measured before the nodule removal using indocyanine green and a scale from 0 to 4.
Secondary Outcomes
- correlation between bowel perfusion after rectal surgery and post-operative complications(up to three months after surgery; from date of surgery until the date of first documented complication, assessed up to 3 months)
- correlation between bowel symptoms and rectosigmoid perfusion after the nodule removal(up to three months after surgery)
Investigators
Mohamed Mabrouk
Principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna