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Indocyanine Green and Rectosigmoid Endometriosis

NCT03532074 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-06-17

No results posted yet for this study

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.

Conditions

  • Endometriosis, Rectum
  • Bowel Endometriosis

Interventions

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

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

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-28
Primary Completion
2019-10-31
Completion
2019-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03532074 on ClinicalTrials.gov