Clinical trial NCT03532074: Indocyanine Green and Rectosigmoid Endometriosis
Official title: Intraoperative Assessment of Bowel Perfusion Through Indocyanine Green in Women With Rectosigmoid Endometriosis and Its Correlation With Clinical and Surgical Data
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometriosis, Rectum
Bowel Endometriosis
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: correlation between bowel symptoms and rectosigmoid perfusion before the nodule removal
timeFrame: intraoperative
Secondary outcomes:
measure: correlation between bowel symptoms and rectosigmoid perfusion after the nodule removal
timeFrame: up to three months after surgery
measure: correlation between bowel perfusion after rectal surgery and post-operative complications
timeFrame: up to three months after surgery; from date of surgery until the date of first documented complication, assessed up to 3 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
Study officials:
References: