Informations générales (source: ClinicalTrials.gov)

NCT02367703 Statut inconnu
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
Interventional
  • Maladies de l'utérus
N/A
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
mars 2015
septembre 2016
29 juin 2024
Hysterectomy for benign uterine disease is often intended to young perimenopausal patients. Currently laparoscopic hysterectomy is commonly used in this indication. We are wondering if decreasing the diameter of laparoscopic instruments could reduce postoperative pain and improve esthetic result without increasing operative time. The purpose of the study is to improve patients' care.
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU de Clermont-Ferrand - 63003 - Clermont-Ferrand - France Patrick LACARIN En recrutement Contact (sur clinicalTrials)

Critères

Femme
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


- 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.