ClinicalTrials.gov
ClinicalTrials.gov Menu

Indocyanine Green and Rectosigmoid Endometriosis (vincendo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03532074
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Mabrouk, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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 intestinal symptoms in patients needing surgery for rectosigmoid endometriosis. Bowel symptoms and rectosigmoid perfusion are assessed before and after surgery.


Condition or disease Intervention/treatment Phase
Endometriosis, Rectum Bowel Endometriosis Diagnostic Test: assessment of bowel symptoms before surgery Diagnostic Test: assessment of rectosigmoid perfusion using indocyanine green Diagnostic Test: follow up and assessment of bowel symptoms after surgery Not Applicable

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 (1.5 mL containing 3.75 mg) are administered through peripheral line. A near-infrared (NIR) camera-head (KARL STORZ Gesellschaft mit beschränkter Haftung & Co., Tuttlingen, Germany) enables after a latency of 5 to 50 seconds a real-time direct visualization of bowel perfusion before and after the removal of the rectosigmoid nodule. Vascularization of rectosigmoid tract 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: OPEN
Primary Purpose: Diagnostic
Official Title: Intraoperative Assessment of Bowel Perfusion Through Indocyanine Green in Women With Rectosigmoid Endometriosis and Its Correlation With Clinical and Surgical Data
Actual Study Start Date : May 28, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
laparoscopic approach
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
validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) are filled in by patients with rectosigmoid endometriosis before surgery

Diagnostic Test: assessment of rectosigmoid perfusion using indocyanine green
indocyanine green (1.5 mL containing 3.75 mg) are 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 Test: 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

robot-assisted approach
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
validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) are filled in by patients with rectosigmoid endometriosis before surgery

Diagnostic Test: assessment of rectosigmoid perfusion using indocyanine green
indocyanine green (1.5 mL containing 3.75 mg) are 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 Test: 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




Primary Outcome Measures :
  1. correlation between bowel symptoms and rectosigmoid perfusion before the nodule removal [ Time Frame: 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 Outcome Measures :
  1. correlation between bowel symptoms and rectosigmoid perfusion after the nodule removal [ Time Frame: 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).

  2. correlation between bowel perfusion after rectal surgery and post-operative complications [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

  • Allergy to iodine
  • Contraindications for laparoscopic surgery
  • Previous rectal surgery
  • Inflammatory Bowel Disease Irritable Bowel Syndrome
  • Cardiovascular problems
  • Hepatic insufficiency
  • Psychiatric diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532074


Contacts
Contact: DIEGO RAIMONDO 00390512144385 DIE.RAIMONDO@GMAIL.COM

Locations
Italy
Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital Recruiting
Bologna, Italy, 40138
Contact: Diego Raimondo    00390512144385    die.raimondo@gmail.com   
Principal Investigator: Mohamed Mabrouk         
Principal Investigator: Renato Seracchioli         
Principal Investigator: Diego Raimondo         
Sub-Investigator: Alessandro Arena         
Sub-Investigator: Raffaella Iodice         
Sub-Investigator: Manuela Mastronardi         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Responsible Party: Mohamed Mabrouk, Principal investigator, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT03532074     History of Changes
Other Study ID Numbers: 290/2017/O/Sper
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female