Indocyanine Green and Rectosigmoid Endometriosis

Endometriosis, Rectum Clinical Trial

— vincendo  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03532074
• Other study ID #: 290/2017/O/Sper
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2018
• Est. completion date: November 2019

Study information

• Verified date: June 2019
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: DIEGO RAIMONDO
• Phone: 00390512144385
• Email: DIE.RAIMONDO[@]GMAIL.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bowel Endometriosis
• Endometriosis
• Endometriosis, Rectum

Intervention

Diagnostic Test:
• assessment 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
• assessment 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
• follow 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
• assessment 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

Locations

Country	Name	City	State
Italy	Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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