Endometriosis, RectumvincendoNCT03532074
Indocyanine Green and Rectosigmoid Endometriosis
A study testing assessment of bowel symptoms before surgery, assessment of rectosigmoid during laparoscopy and follow up and assessment of bowel symptoms after surgery in people with Endometriosis, Rectum and Bowel Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis, Rectum, Bowel Endometriosis
- What is being tested?
- assessment of bowel symptoms before surgery, assessment of rectosigmoid during laparoscopy and follow up and assessment of bowel symptoms after surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 28 May 2018to Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Gynecology and Physiopathology of Human Reproductive Unit, University of Bologna, S. Orsola-Malpighi Hospital
Bologna, 40138
Diego Raimondo, 00390512144385, die.raimondo@gmail.com
Mohamed Mabrouk
About this study
Official title: 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.
Read the 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.
- Conditions
- Endometriosis, Rectum, Bowel Endometriosis
- Being tested
- assessment of bowel symptoms before surgery, assessment of rectosigmoid during laparoscopy, follow up and assessment of bowel symptoms after surgery, assessment of rectosigmoid perfusion during robot-assisted laparoscopy
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of bowel symptoms before surgeryDiagnostic test
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 laparoscopyDiagnostic test
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 surgeryDiagnostic test
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 laparoscopyDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic approach | Other | 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 Receives: Diagnostic Test: assessment of bowel symptoms before surgery; Diagnostic Test: assessment of rectosigmoid during laparoscopy; Diagnostic Test: follow up and assessment of bowel symptoms after surgery |
| robot-assisted approach | Other | 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 Receives: Diagnostic Test: assessment of bowel symptoms before surgery; Diagnostic Test: follow up and assessment of bowel symptoms after surgery; Diagnostic Test: assessment of rectosigmoid perfusion during robot-assisted laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intraoperative
Secondary outcomes (2)
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).
Measured: up to three months after surgery
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.
Measured: up to three months after surgery; from date of surgery until the date of first documented complication, assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start28 May 2018
- Primary completionOct 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometriosis, RectumStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mabrouk, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532074
- Sponsor's protocol ID
- 290/2017/O/Sper
- Acronym
- vincendo
- Status last verified
- Jun 2019
- First submitted
- 9 Apr 2018
- Last updated
- 17 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Assessment of Bowel Perfusion Through Indocyanine Green in Women With Rectosigmoid Endometriosis and Its Correlation With Clinical and Surgical Data
- ClinicalTrials.gov ID
- NCT03532074
- Acronym / sponsor ID
- vincendo / 290/2017/O/Sper
- Conditions
- Endometriosis, Rectum, Bowel Endometriosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 28 May 2018 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic approach | Other | Diagnostic Test: assessment of bowel symptoms before surgery, Diagnostic Test: assessment of rectosigmoid during laparoscopy, Diagnostic Test: follow up and assessment of bowel symptoms after surgeryassessment 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 | Other | Diagnostic Test: assessment of bowel symptoms before surgery, Diagnostic Test: follow up and assessment of bowel symptoms after surgery, Diagnostic Test: assessment of rectosigmoid perfusion during robot-assisted laparoscopyassessment 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- Known or suspected allergy to iodine
- Previous rectal surgery
- History of active pelvic infection
- Intra-abdominal or pelvic malignancy
- Pelvic radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment of bowel symptoms before surgeryvalidated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) are filled in by patients with rectosigmoid endometriosis before surgery | Diagnostic test | laparoscopic approach, robot-assisted approach |
| assessment of rectosigmoid during laparoscopyindocyanine 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 | laparoscopic approach |
| follow up and assessment of bowel symptoms after surgeryvalidated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) are filled in by patients with rectosigmoid endometriosis after surgery | Diagnostic test | laparoscopic approach, robot-assisted approach |
| assessment of rectosigmoid perfusion during robot-assisted laparoscopyindocyanine 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 | Diagnostic test | robot-assisted approach |
Primary outcome
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.
2 secondary outcomes
correlation between bowel symptoms and rectosigmoid perfusion after the nodule removal
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assessment of bowel symptoms before surgery, assessment of rectosigmoid during laparoscopy and follow up and assessment of bowel symptoms after surgery in people with Endometriosis, Rectum and Bowel Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DIEGO RAIMONDO (00390512144385, DIE.RAIMONDO@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between bowel symptoms and rectosigmoid perfusion before the nodule removal (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.