Indocyanine Green and Rectosigmoid Endometriosis (vincendo)

June 13, 2019 updated by: Mohamed Mabrouk, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
        • Contact:
        • Principal Investigator:
          • Mohamed Mabrouk
        • Principal Investigator:
          • Renato Seracchioli
        • Principal Investigator:
          • Diego Raimondo
        • Sub-Investigator:
          • Raffaella Iodice
        • Sub-Investigator:
          • Manuela Mastronardi
        • Sub-Investigator:
          • Alessandro Arena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 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 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
Other: 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: 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
Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
up to three months after surgery
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.
up to three months after surgery; from date of surgery until the date of first documented complication, assessed up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2018

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

May 19, 2018

First Posted (Actual)

May 22, 2018

Study Record Updates

Last Update Posted (Actual)

June 17, 2019

Last Update Submitted That Met QC Criteria

June 13, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 290/2017/O/Sper

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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