Indocyanine Green and Rectosigmoid Endometriosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intraoperative Assessment of Bowel Perfusion Through Indocyanine Green in Women With Rectosigmoid Endometriosis and Its Correlation With Clinical and Surgical Data

Conditions
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Endometriosis, Rectum, Bowel Endometriosis

Intervention / Treatment
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* Diagnostic Test: assessment of bowel symptoms before surgery
* Diagnostic Test: assessment of rectosigmoid during laparoscopy
* Diagnostic Test: follow up and assessment of bowel symptoms after surgery
* Diagnostic Test: assessment of rectosigmoid perfusion during robot-assisted laparoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: laparoscopic approach<br>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 | Diagnostic Test: assessment of bowel symptoms before surgery<br>* validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) are filled in by patients with rectosigmoid endometriosis before surgery<br>Diagnostic Test: assessment of rectosigmoid during laparoscopy<br>* indocyanine green (0.25 mg/kg) is administered through peripheral line. A near-infrared camera-head (KARL STORZ Gesellschaft mit beschränkter Haftung & Co., Tuttlingen, Germany) is used to visualize bowel perfusion before and after the removal of the rectosigmoid nodule. To estimate the vascularization, a scale with a score between 0 and 4 is used<br>Diagnostic Test: follow up and assessment of bowel symptoms after surgery<br>* validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) are filled in by patients with rectosigmoid endometriosis after surgery<br>|
| Other: robot-assisted approach<br>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 | Diagnostic Test: assessment of bowel symptoms before surgery<br>* validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) are filled in by patients with rectosigmoid endometriosis before surgery<br>Diagnostic Test: follow up and assessment of bowel symptoms after surgery<br>* validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) are filled in by patients with rectosigmoid endometriosis after surgery<br>Diagnostic Test: assessment of rectosigmoid perfusion during robot-assisted laparoscopy<br>* indocyanine green (0.25 mg/kg) is administered through peripheral line. The robotic Firefly imaging system (daVinciXi surgical platform; Intuitive Surgical, Sunnyvale, CA) is used to visualize bowel perfusion before and after the removal of the rectosigmoid nodule. To estimate the vascularization, a scale with a score between 0 and 4 is used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between bowel symptoms and rectosigmoid perfusion before the nodule removal | 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. | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between bowel symptoms and rectosigmoid perfusion after the nodule removal | comparison between rectosigmoid perfusion, measured after the nodule removal using indocyanine green and a scale from 0 to 4, and bowel symptoms, assessed through validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index). | up to three months after surgery | 
| correlation between bowel perfusion after rectal surgery and post-operative complications | assessment of rectosigmoid perfusion, through indocyanine green and a scale from 0 to 4, and complications (rectovaginal fistula, dehiscence of anastomotic suture, rectal bleeding, rectosigmoid perforation, rectosigmoid stenosis), using Clavien-Dindo Classification. | up to three months after surgery; from date of surgery until the date of first documented complication, assessed up to 3 months |