Hysterectomie door transvaginale natuurlijke opening Transluminale endoscopische chirurgie versus of laparoscopische hysterectomie (vNOTESHC)
vNOTEsHC: Hysterectomie door transvaginale natuurlijke opening Transluminale endoscopische chirurgie versus of laparoscopische hysterectomie: een gerandomiseerde gecontroleerde studie
In France, there are approximately 62,000 hysterectomies per year, 70% of which are benign. It is the most frequent surgical procedure in gynecology.
Hysterectomies are performed via 3 routes: laparotomy, laparoscopy or vaginal route.
This choice of approach is particularly important in the case of large uteri (50% of uteri > 280g), which increase the risks of laparoconversion and bladder injury (NP3).
The vaginal route reduces the operating time and postoperative pain. Laparoscopy allows a better anatomical view and easier access to the neighbouring organs, which makes it the preferred approach, especially for young surgeons and when the uterus is large. However, the laparoscopic route is associated with an increase in the rate of conversion to laparotomy according to the volume of the uterus, as well as the rate of general per and postoperative complications compared with vaginal hysterectomy for uteri > 280 g. In a meta-analysis comparing laparoscopy and vaginal hysterectomy, the total prevalence of perioperative complications according to the classification of Clavien and Dindo was 27%. For large uteruses, complications by the vaginal route amounted to 15% and those by the laparoscopic route to 37.5%.
The data are not sufficient to give preference to one or other of the approaches, but for benign pathologies, for large uteri (>280 g), the minimally invasive laparoscopic or vaginal approaches are recommended by the CNGOF (grade C).
A new Medical Device (MD), the vNOTES (Vaginal Natural Orifice Transluminal Endoscopy System) offers the advantage of two approaches for pelvic surgery by allowing minimally invasive surgery to be performed by endoscopy through the vagina, offering perfect vision for the assistants and the operator and without scarring. Two randomized trials have shown that vNOTES allows, compared to laparoscopy, to perform adnexectomies and hysterectomies without conversion with less pain, fewer postoperative complications and a shorter hospitalization time.
The first evaluations of vNOTES are encouraging and suggest a new era for pelvic surgery: less postoperative pain, fewer complications and facilitation of ambulatory care. Also the videoscopic assistance of the vNOTES is a pedagogical tool for the vaginal route because the field of vision is no longer limited to the operator alone. However, the vNOTES has only been evaluated by the developers of the tool, in monocentric studies and in small numbers. The hysterectomy study evaluated only 35 patients with vNOTES, half of whom had a uterus of less than 280 g. The benefit of vNOTES for uteri smaller than 280 g is not obvious because of the ease of the surgical procedure and the cost of the "classic" vaginal route. Our study would be the first multicentric and academic study on vNOTES to focus specifically on large volume uteri, the most difficult to operate and prone to postoperative complications.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Florence RANCON
- Telefoonnummer: +33 0477829458
- E-mail: florence.rancon@chu-st-etienne.fr
Studie Contact Back-up
- Naam: Céline CHAULEUR, PhD
- Telefoonnummer: +33 0477828383
- E-mail: celine.chauleur@chu-st-etienne.fr
Studie Locaties
-
-
-
Bron, Frankrijk, 69677
- Nog niet aan het werven
- HFME - Hospices Civils de Lyon
-
Hoofdonderzoeker:
- Géry LAMBLIN
-
Contact:
- Géry LAMBLIN
- E-mail: gery.lamlin@chu-lyon.fr
-
Clermont-Ferrand, Frankrijk, 63003
- Werving
- CHU Clermont-Ferrand
-
Onderonderzoeker:
- Sandra CURINIER, PH
-
Contact:
- Sandrine CAMPAGNE-LOISEAU, PH
- E-mail: scampagne-loiseau@chu-clermontferrand.fr
-
Hoofdonderzoeker:
- Sandrine CAMPAGNE-LOISEAU, PH
-
Issoire, Frankrijk, 63500
- Nog niet aan het werven
- Ch Issoire
-
Contact:
- Aslam MANSOOR
- E-mail: amansoor@ch-issoire.fr
-
Hoofdonderzoeker:
- Aslam MANSOOR, PH
-
Limoges, Frankrijk, 87042
- Nog niet aan het werven
- CHU LIMOGES - Hôpital de la mère et de l'Enfant
-
Contact:
- Tristan GAUTHIER, PhD
- Telefoonnummer: +33 (0)5 55 05 61 64
- E-mail: tristan.gauthier@chu-limoges.fr
-
Saint-Etienne, Frankrijk, 42100
- Nog niet aan het werven
- Clinique Mutualiste de Saint-Etienne
-
Contact:
- Quentin REBOUL, MD
- E-mail: quentinreboul@free.fr
-
Hoofdonderzoeker:
- Quentin REBOUL, MD
-
Saint-Etienne, Frankrijk, 42055
- Nog niet aan het werven
- CHU Saint-Etienne
-
Contact:
- Céline CHAULEUR, PhD
- Telefoonnummer: 0477828383
- E-mail: celine.chauleur@chu-st-etienne.fr
-
Hoofdonderzoeker:
- Thomas CORSINI
-
Onderonderzoeker:
- Céline CHAULEUR
-
Onderonderzoeker:
- Ahamd MEDHI
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Any woman received in preoperative consultation in the Gynecology-Obstetrics Department for a benign pathology of a uterus estimated to be large requiring a hysterectomy.
- Patient affiliated or entitled to a social security system
- Patients over 18 years of age
- Patients having given their agreement to participate and after signing the consent form
Exclusion Criteria:
- Woman refusing to participate in the study (lack of consent)
- Non-French speaking woman (unable to conduct a good quality interview of the pregnant woman)
- Participation in another interventional study.
- Patient subject to a legal protection measure or unable to express her consent
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: laparoscopic hysterectomy
Laparoscopic Hysterectomy will be performed in a standardized manner with or without surgical robot |
laparoscopic hysterectomy uses a standardized procedure with or without surgical robot |
|
Experimenteel: natural vaginal orifice transluminal endoscopic system for hysterectomies (vNOTES)
Vaginal hysterectomy will be performed in a standardized manner using transluminal endoscopic system |
hysterectomy via the vaginal approach by vNOTES (natural vaginal orifice transluminal endoscopic system for hysterectomies) |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Proportion of patient with complications
Tijdsspanne: From surgery to 6 weeks of surgery
|
The proportion of patients with at least one pre- and post-operative complication at 6 weeks will be estimated along with its 95% confidence interval in each surgical strategy group. The primary endpoint is a composite endpoint including the occurrence of intraoperative and postoperative complications within 6 weeks of surgery. Postoperative complications were Infectious complications, Bleeding complications and All hospital readmissions related to the procedure Postoperative complications will be classified according to the Clavien-Dindo classification Intraoperative complications will be defined as :
|
From surgery to 6 weeks of surgery
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Conversion
Tijdsspanne: During surgery
|
Number of patients with conversion during surgery |
During surgery
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Post-operative pain
Tijdsspanne: From surgery to 3 hours of surgery
|
Maximal Pain measured by a numerical scale : 0 no pain / 10 maximum pain |
From surgery to 3 hours of surgery
|
|
Short-term postoperative pain
Tijdsspanne: From surgery to 1 week after surgery
|
Maximal short-term postoperative pain the first week after surgery measured by a numerical scale (0 no pain / 10 maximum pain) by a daily telephone call |
From surgery to 1 week after surgery
|
|
Duration of postoperative reflex ileus
Tijdsspanne: Day 0
|
Duration of post-operative reflex ileus between the day of the operation and the resumption of a transit (appearance of the first gas) in hours |
Day 0
|
|
Duration of the operation
Tijdsspanne: Surgery
|
operative time will be evaluated between the incision and the end of the closure, in minutes. |
Surgery
|
|
Duration of hospitalization and the possibility of returning home
Tijdsspanne: last day of hospitalization
|
The length of hospital stay will be assessed in days and the possibility of return home by the time in hours from surgical incision to a Chung≥ score of 9/10. The Chung score assesses the possibility of a return home in ambulatory surgery. |
last day of hospitalization
|
|
Sexual dysfunction
Tijdsspanne: 3 months
|
Sexual disorders: sexual life will be assessed by the difference in the specific validated score (self-questionnaire) (PISQ12 with a score ranging from 0 to 48) between the inclusion date and 3 months after surgery for sexually active women. |
3 months
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Céline CHAULEUR, PhD, Centre Hospitalier Universitaire de Saint Etienne
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 21PH265
- 2023-A01013-42 (Andere identificatie: ANSM)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .