HYSTINDO_Study of the vascularization of the vaginal slice after total laparoscopic hysterectomy, using indocyanine green injection. Prospective feasibility study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Hospital Of Clermont-Ferrand

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trial duration

20 Sep 2024 → ongoing

Decision date (initial)

2024-07-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

Study the presence of indocyanine green at the level of the vaginal slice in surgical treatment by laparoscopic total hysterectomy, in order to evaluate vascularization of the area intraoperatively

Secondary objectives 9

1. Study the different parameters from the perfusion curve
2. Compare objective fluorescence measurements with surgeon judgment
3. Evaluate the immediate or delayed tolerance of indocyanine green in the context studied
4. Evaluate the time added by the protocol to the total operating time
5. Compare the vascularization of the vaginal slice according to patient characteristics
6. Compare the vascularization of the vaginal slice according to surgical technique
7. Compare the vascularization of the vaginal slice according to the type of camera
8. Compare the vascularization of the vaginal slice according to post-operative complications
9. Compare the vascularization of the vaginal slice according to the condition of the vaginal fundus scar

Conditions and MedDRA coding

total hysterectomy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Adult patient
2. Patient requiring hysterectomy by surgical treatment accessible by laparoscopy

Exclusion criteria 5

1. Protected patient, under guardianship, curatorship or legal protection
2. Patient refusal or poor understanding of the French language
3. Known allergy to iodine
4. Current pregnancy and breastfeeding
5. Intervention requiring the use of indocyanine green

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Evolution of green levels in an area of ​​interest, from which a time-fluorescence curve can be obtained. The presence of fluorescence will be defined by the fluorescence intensity value Fmax-Fmin.

Secondary endpoints 9

1. The different parameters from the perfusion curve: minimum fluorescence intensity Fmin, fluorescence intensity Fmax, the difference in fluorescence intensity Fmax-min, the slope of the fluorescence intensity, the time ratio TR
2. Objective measurements of fluorescence and the surgeon's assessment (Likert scale)
3. From the injection of indocyanine green during the procedure until the post-operative consultation, the side effects and the occurrence of adverse events linked to the injection of indocyanine green will be noted
4. The time added by the protocol to the total operating time. The duration of the phase corresponding to the protocol will be equal to the time between the injection of indocyanine green and the stopping of video recording in minutes. The total operating time will be equal to the time between the incision time and the closing time in minutes
5. The vascularization of the vaginal slice defined by a fluorescence intensity value Fmax-Fmin on the graph according to patient characteristics
6. The vascularization of the vaginal slice defined by a fluorescence intensity value Fmax-Fmin on the graph according to surgical technique (coagulation tool and method, type of energy, type of suture, type of thread).
7. The vascularization of the vaginal slice defined by a fluorescence intensity value Fmax-Fmin on the graph according to the type of camera (SPIES, RUBINA and FIREFLY systems).
8. The vascularization of the vaginal slice defined by a fluorescence intensity value Fmax-Fmin on the graph according to post-operative complications (bleeding, fever, biological inflammatory syndrome, pain, early post-operative abscess, hemoperitoneum, hematoma, infection/abscess, fistula).
9. The vascularization of the vaginal slice defined by a fluorescence intensity value Fmax-Fmin on the graph according to the condition of the vaginal fundus scar

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Hospital Of Clermont-Ferrand

Sponsor organisation

University Hospital Of Clermont-Ferrand

Address

58 Rue Montalembert

City

Clermont Ferrand Cedex 1

Postcode

63003

Country

France

Scientific contact point

Organisation

University Hospital Of Clermont-Ferrand

Contact name

Lise Laclautre

Public contact point

Organisation

University Hospital Of Clermont-Ferrand

Contact name

Lise Laclautre

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications