Deep EndometriosisPhase 4INDIENCT03080558
Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving
A Phase 4 study testing Indocyanine green in people with Deep Endometriosis and Recto Vaginal Node, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Indocyanine green is a dye, using in surgery to bring out the intraoperative evaluation of tissue perfusion. After intravenous injection of indocyanine green, using a near infrared light, the vascularisation becomes fluorescent. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Deep Endometriosis, Recto Vaginal Node
- What is being tested?
- Indocyanine green
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 6 Aug 2017to 28 Feb 2019
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above the age of 18 year
- Patients with endometriosis recto vaginal node
- Patients with operative indications of rectal shaving, with or without vaginal resection
- Patients who have accepted to participate
Who cannot join
- minors patients
- Patients under guardianship or wardship
- Patients who refused the participation
- Iodine allergy
- Pregnant woman
- Patients during lactation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Nicolas BOURDEL
About this study
Official title: Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving, Using Indocyanine Green Injection. Feasibility Study
Indocyanine green is a dye, using in surgery to bring out the intraoperative evaluation of tissue perfusion.
After intravenous injection of indocyanine green, using a near infrared light, the vascularisation becomes fluorescent.
In endometriosis disease, the treatment of recto vaginal node can be complicated by rectovaginal fistula.
An abnormal vascularisation related to the surgery would be a risk factor of post operative fistulas.
The aim of this study is to evaluate the rectal and vaginal vascularisation during the treatment of a recto vaginal endometriosis nodule with rectal shaving, using indocyanine green fluorescence.
Read the detailed description
Investigators are going to inject, at the end of a rectal shaving, a bolus of 0,2mg/kg of indocyanine green after dilution (2,5mg/ml). With de SPIES system (KARL STORZ GmbH \& Co. KG, Tuttlingen, Germany), the vascularisation would be imediately fluorescent. Investigators are going to estimate the vascularization of the rectal serosa and mucosa where the nodule was located.
If a vaginal resection has been performed, investigators are going to estimate the vascularization of the vaginal scar.
To estimate de vascularization, investigators are going tu use a scale with a score between 0 and 4.
After the surgery, the post-operative follow-up with be the same as usual after a Rectal Shaving.
- Conditions
- Deep Endometriosis, Recto Vaginal Node
- Being tested
- Indocyanine green
- Keywords
- Indocyanine green fluorescence, Rectal vascularisation, Vaginal vascularisation, Laparoscopic surgery, Rectal shaving, Recto vaginal node, Deep Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine greenDrug
Use of Indocyanine Green during Rectal shaving by laparoscopy.
| Study group | Role | What they receive |
|---|---|---|
| endometriosis recto vaginal node | Experimental | Not described Receives: Drug: Indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per-operative evaluation of the rectum
Per-operative evaluation of the rectum after Shaving, using indocyanine green fluorescence, by transperitoneal and intra-rectal approach, and vaginal suture if there is an associated vaginal resection. A fluorescence score between 0 and 4 will be used, based on a Likert scale
Measured: at day 1
Secondary outcomes (2)
Side effects after indocyanine green injection
Measured: at day 1
Post operative complications
infections, abdominal abscess, abdominal hematoma, post operative fistula.
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start6 Aug 2017
- Primary completion28 Feb 2019 (estimated)
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Deep EndometriosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire SERB, Association GEGO
- Responsible party
- Sponsor
- Investigators
- Nicolas BOURDEL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080558
- Sponsor's protocol ID
- CHU-305
- Other IDs
- 2016-002773-35, 2016
- Acronym
- INDIE
- Status last verified
- Feb 2019
- First submitted
- 6 Mar 2017
- Last updated
- 4 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bourdel N, Jaillet L, Bar-Shavit Y, Comptour A, Pereira B, Canis M, Chauvet P. Indocyanine green in deep infiltrating endometriosis: a preliminary feasibility study to examine vascularization after rectal shaving. Fertil Steril. 2020 Aug;114(2):367-373. doi: 10.1016/j.fertnstert.2020.03.042. Epub 2020 Jul 7.
PubMed 32646588Bar-Shavit Y, Jaillet L, Chauvet P, Canis M, Bourdel N. Use of indocyanine green in endometriosis surgery. Fertil Steril. 2018 Jun;109(6):1136-1137. doi: 10.1016/j.fertnstert.2018.02.113. Epub 2018 Jun 6.
PubMed 29885885
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving, Using Indocyanine Green Injection. Feasibility Study
- ClinicalTrials.gov ID
- NCT03080558
- Acronym / sponsor ID
- INDIE / CHU-305
- Conditions
- Deep Endometriosis, Recto Vaginal Node
- Keywords
- Indocyanine green fluorescence, Rectal vascularisation, Vaginal vascularisation, Laparoscopic surgery, Rectal shaving, Recto vaginal node, Deep Endometriosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Laboratoire SERB, Association GEGO
- Study start
- 6 Aug 2017 (actual)
- Primary completion
- 28 Feb 2019 (estimated)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 15 Mar 2017 (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 dye, using in surgery to bring out the intraoperative evaluation of tissue perfusion.
After intravenous injection of indocyanine green, using a near infrared light, the vascularisation becomes fluorescent.
In endometriosis disease, the treatment of recto vaginal node can be complicated by rectovaginal fistula.
An abnormal vascularisation related to the surgery would be a risk factor of post operative fistulas.
The aim of this study is to evaluate the rectal and vaginal vascularisation during the treatment of a recto vaginal endometriosis nodule with rectal shaving, using indocyanine green fluorescence.
Detailed description
Investigators are going to inject, at the end of a rectal shaving, a bolus of 0,2mg/kg of indocyanine green after dilution (2,5mg/ml). With de SPIES system (KARL STORZ GmbH \& Co. KG, Tuttlingen, Germany), the vascularisation would be imediately fluorescent. Investigators are going to estimate the vascularization of the rectal serosa and mucosa where the nodule was located.
If a vaginal resection has been performed, investigators are going to estimate the vascularization of the vaginal scar.
To estimate de vascularization, investigators are going tu use a scale with a score between 0 and 4.
After the surgery, the post-operative follow-up with be the same as usual after a Rectal Shaving.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endometriosis recto vaginal node | Experimental | Drug: Indocyanine green |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients above the age of 18 year
- Patients with endometriosis recto vaginal node
- Patients with operative indications of rectal shaving, with or without vaginal resection
- Patients who have accepted to participate
Key exclusion criteria (6 listed)
- minors patients
- Patients under guardianship or wardship
- Patients who refused the participation
- Iodine allergy
- Pregnant woman
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 |
|---|---|---|
| Indocyanine greenUse of Indocyanine Green during Rectal shaving by laparoscopy. | Drug | endometriosis recto vaginal node |
Primary outcome
Per-operative evaluation of the rectum
Time frame: at day 1
Per-operative evaluation of the rectum after Shaving, using indocyanine green fluorescence, by transperitoneal and intra-rectal approach, and vaginal suture if there is an associated vaginal resection. A fluorescence score between 0 and 4 will be used, based on a Likert scale
2 secondary outcomes
Side effects after indocyanine green injection
Time frame: at day 1
Post operative complications
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Derived from this study: PubMed 32646588Bourdel N, Jaillet L, Bar-Shavit Y, Comptour A, Pereira B, Canis M, Chauvet P. Indocyanine green in deep infiltrating endometriosis: a preliminary feasibility study to examine vascularization after rectal shaving. Fertil Steril. 2020 Aug;114(2):367-373. doi: 10.1016/j.fertnstert.2020.03.042. Epub 2020 Jul 7.
- Derived from this study: PubMed 29885885Bar-Shavit Y, Jaillet L, Chauvet P, Canis M, Bourdel N. Use of indocyanine green in endometriosis surgery. Fertil Steril. 2018 Jun;109(6):1136-1137. doi: 10.1016/j.fertnstert.2018.02.113. Epub 2018 Jun 6.
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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.
Nicolas BOURDEL principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indocyanine green in people with Deep Endometriosis and Recto Vaginal Node, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 4 inclusion and 6 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 4 Feb 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 France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Patrick LACARIN (0473751195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per-operative evaluation of the rectum (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03080558, which also lists 2 linked publications.
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 4 Feb 2019.