Feasibility and Benefit of Laparoscopic Hysterectomy With Less Than 3 Millimeter Diameter's Instruments in Current Practice
Assessment of Feasibility and Benefit of the Use of Less Than 3 Millimeter Diameter's Instruments Compared to Standard Size Instruments in Laparoscopic Hysterectomy: a Randomized Single-center Comparative Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy.
The study will be unicentric, single-blind. Study period will be one year and 4 months. Patients will be enrolled in pre-operative consultations or at the weekly staff. They will have to sign an informed consent.
The day before surgery: patients will be randomized by the statistician. A resident will carry out a preoperative ultrasound to determine an estimated uterine volume. Nurses will make a blood test (hemoglobin).
The day of surgery we will assess: operative time, surgeon's ergonomics, the amount of bleeding, patient's pain at rest and mobilization.
At Day-1 post surgery nurses will make an other blood test (hemoglobin) and we will assess patient's pain at rest and mobilization.
At the postoperative consultation we will lister : complications (Accordion Severity score classification), esthetic result (PSAQ), patient's pain.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
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Clermont-Ferrand, France, 63003
- Recrutement
- CHU de Clermont-Ferrand
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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:
- patient candidate for total inter-adnexal hysterectomy or for hysterectomy with oophorectomy and
- benign gynecological pathology: fibroids, adenomyosis, polyps, dysfunctional uterine bleeding.
and
- affiliation to social security and
- informed consent
Exclusion Criteria:
- ASA III or IV patients,
- age> 80 years old,
- history of major abdominal surgery by laparotomy
- severe obesity (BMI> 35kg / m2)
- pathology of hemostasis and coagulation (liver disease, bleeding disorders)
- uterine volume estimated on preoperative ultrasonography > 300 g
- minor patients,
- adult lacking legal capacity
- patients suffering from mental illness incompatible with informed consent, refusal to participate.
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 |
|---|---|
|
Expérimental: standard instrument
That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy
|
|
|
Autre: less than 3 millimeter diameter's instruments
That is why we propose a randomized comparative study between standard instrument and less than 3 millimeter diameter's instruments to achieve in daily practice laparoscopic hysterectomy
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
operative time
Délai: at day 1 (at the end of the surgery)
|
at day 1 (at the end of the surgery)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
quantity of intraoperative bleeding
Délai: at day 1 (at the end of the intervention)
|
at day 1 (at the end of the intervention)
|
|
|
hemoglobin
Délai: at day 1
|
at day 1
|
|
|
Pain Rating Scale (VAS)
Délai: at day 1 (at 6 hours potoperative hours)
|
at day 1 (at 6 hours potoperative hours)
|
|
|
Pain Rating Scale (VAS)
Délai: at day 1 (at 24 postoperative hours)
|
at day 1 (at 24 postoperative hours)
|
|
|
standard laparoscopy conversion rate
Délai: at day 1
|
at day 1
|
|
|
postoperative complications
Délai: at each additional hospitalisation
|
postoperative complications according Accordion Severity Classification score (grade> or = 2) listed at each additional hospitalisation
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at each additional hospitalisation
|
|
Patient Scar Assessment Scale (PSAS)
Délai: at 6 and 8 weeks after surgery.
|
Patient Scar Assessment Scale (PSAS)completed at the time of post-operative consultation
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at 6 and 8 weeks after surgery.
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Surgen's ergonomics
Délai: at the end of the surgery
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Surgen's ergonomics evaluated at the end of the surgery (NASA-TLX scale)
|
at the end of the surgery
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Revaz BOTCHORISHVILI, CHU de Clermont-Ferrand
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
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
- CHU-0223
- 2014-A01698-39 (Autre identifiant: ANSM)
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