Hystérectomie par orifice naturel transvaginal Chirurgie endoscopique transluminale versus hystérectomie laparoscopique (vNOTESHC)
vNOTEsHC : Hystérectomie par chirurgie endoscopique transluminale par orifice naturel transvaginal versus hystérectomie laparoscopique : un essai contrôlé randomisé
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Florence RANCON
- Numéro de téléphone: +33 0477829458
- E-mail: florence.rancon@chu-st-etienne.fr
Sauvegarde des contacts de l'étude
- Nom: Céline CHAULEUR, PhD
- Numéro de téléphone: +33 0477828383
- E-mail: celine.chauleur@chu-st-etienne.fr
Lieux d'étude
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Bron, France, 69677
- Pas encore de recrutement
- HFME - Hospices Civils de Lyon
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Chercheur principal:
- Géry LAMBLIN
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Contact:
- Géry LAMBLIN
- E-mail: gery.lamlin@chu-lyon.fr
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Clermont-Ferrand, France, 63003
- Recrutement
- CHU Clermont-Ferrand
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Sous-enquêteur:
- Sandra CURINIER, PH
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Contact:
- Sandrine CAMPAGNE-LOISEAU, PH
- E-mail: scampagne-loiseau@chu-clermontferrand.fr
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Chercheur principal:
- Sandrine CAMPAGNE-LOISEAU, PH
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Issoire, France, 63500
- Pas encore de recrutement
- Ch Issoire
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Contact:
- Aslam MANSOOR
- E-mail: amansoor@ch-issoire.fr
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Chercheur principal:
- Aslam MANSOOR, PH
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Limoges, France, 87042
- Pas encore de recrutement
- CHU LIMOGES - Hôpital de la mère et de l'Enfant
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Contact:
- Tristan GAUTHIER, PhD
- Numéro de téléphone: +33 (0)5 55 05 61 64
- E-mail: tristan.gauthier@chu-limoges.fr
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Saint-Etienne, France, 42100
- Pas encore de recrutement
- Clinique Mutualiste de Saint-Etienne
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Contact:
- Quentin REBOUL, MD
- E-mail: quentinreboul@free.fr
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Chercheur principal:
- Quentin REBOUL, MD
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Saint-Etienne, France, 42055
- Pas encore de recrutement
- CHU Saint-Etienne
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Contact:
- Céline CHAULEUR, PhD
- Numéro de téléphone: 0477828383
- E-mail: celine.chauleur@chu-st-etienne.fr
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Chercheur principal:
- Thomas CORSINI
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Sous-enquêteur:
- Céline CHAULEUR
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Sous-enquêteur:
- Ahamd MEDHI
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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 |
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Expérimental: 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) |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Proportion of patient with complications
Délai: From surgery to 6 weeks of surgery
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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 :
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From surgery to 6 weeks of surgery
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Conversion
Délai: During surgery
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Number of patients with conversion during surgery |
During surgery
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Post-operative pain
Délai: From surgery to 3 hours of surgery
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Maximal Pain measured by a numerical scale : 0 no pain / 10 maximum pain |
From surgery to 3 hours of surgery
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Short-term postoperative pain
Délai: From surgery to 1 week after surgery
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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
|
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Duration of postoperative reflex ileus
Délai: 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
|
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Duration of the operation
Délai: Surgery
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operative time will be evaluated between the incision and the end of the closure, in minutes. |
Surgery
|
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Duration of hospitalization and the possibility of returning home
Délai: 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
|
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Sexual dysfunction
Délai: 3 months
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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
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Céline CHAULEUR, PhD, Centre Hospitalier Universitaire de Saint Etienne
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 21PH265
- 2023-A01013-42 (Autre identifiant: ANSM)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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