Condition: Hysterectomy, Vaginal · Sponsor: Centre Hospitalier Universitaire de Saint Etienne
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 vN…
This description comes directly from the study's public registry record.
Céline CHAULEUR, PhD · 0477828383 · celine.chauleur@chu-st-etienne.fr
Florence RANCON · 0477829458 · florence.rancon@chu-st-etienne.fr
Always discuss trial participation with your own doctor first.
| HFME - Hospices Civils de Lyon | Bron, France | Not Yet Recruiting |
| CHU Clermont-Ferrand | Clermont-Ferrand, France | Recruiting |
| Ch Issoire | Issoire, France | Not Yet Recruiting |
| CHU LIMOGES - Hôpital de la mère et de l'Enfant | Limoges, France | Not Yet Recruiting |
| CHU Saint-Etienne | Saint-Etienne, France | Not Yet Recruiting |
| Clinique Mutualiste de Saint-Etienne | Saint-Etienne, France | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT05884658