Indocyanine Green and Rectosigmoid Endometriosis
vincendo
Intraoperative Assessment of Bowel Perfusion Through Indocyanine Green in Women With Rectosigmoid Endometriosis and Its Correlation With Clinical and Surgical Data
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2018
CompletedFirst Posted
Study publicly available on registry
May 22, 2018
CompletedStudy Start
First participant enrolled
May 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedJune 17, 2019
June 1, 2019
1.3 years
April 9, 2018
June 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
correlation between bowel symptoms and rectosigmoid perfusion after the nodule removal
up to three months after surgery
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
Study Arms (2)
laparoscopic approach
OTHERassessment 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
robot-assisted approach
OTHERassessment 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
Interventions
validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) are filled in by patients with rectosigmoid endometriosis before surgery
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
validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) are filled in by patients with rectosigmoid endometriosis after surgery
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
Bologna, 40138, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- OPEN
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
April 9, 2018
First Posted
May 22, 2018
Study Start
May 28, 2018
Primary Completion
October 1, 2019
Study Completion
November 1, 2019
Last Updated
June 17, 2019
Record last verified: 2019-06