Bowel Endometriosis, Endometriosis, Rectum
Conditions
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.
Interventions
DIAGNOSTIC_TESTassessment of bowel symptoms before surgery
validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) are filled in by patients with rectosigmoid endometriosis before surgery
DIAGNOSTIC_TESTassessment of rectosigmoid during laparoscopy
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
DIAGNOSTIC_TESTfollow up and assessment of bowel symptoms after surgery
validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) are filled in by patients with rectosigmoid endometriosis after surgery
DIAGNOSTIC_TESTassessment of rectosigmoid perfusion during robot-assisted laparoscopy
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
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
OPEN
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| correlation between bowel symptoms and rectosigmoid perfusion before the nodule removal | 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
| Measure | Time frame | Description |
|---|---|---|
| correlation between bowel symptoms and rectosigmoid perfusion after the nodule removal | up to three months after surgery | 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). |
| 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 | 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. |
Countries
Italy
Contacts
Primary ContactDIEGO RAIMONDO
Outcome results
None listed