Hysterectomy, Laparoscopy, vNOTES
Conditions
Brief summary
During a first consultation with an indication of total hysterectomy for a benign lesion, we will study the patient's eligibility. After explanations of the study and submission of the forms, the patient will benefit from a second consultation with the investigator to give her consent. The surgeon will randomize the patient using RedCap computer software. The patient will then be referred either to the vNOTES group or to the laparoscopy group. The surgery will be performed by surgeons called "expert" in one of the ways first. For this, it will be necessary to have performed at least 25 hysterectomies by laparoscopy or vNOTES. The surgery will take place using the usual techniques. Per and postoperative complications will be studied and noted up to six months postoperatively.
Interventions
PROCEDURELaparoscopy
The hysterectomy is performed by laparoscopy as described in the EMC.
PROCEDUREvNOTES
The hysterectomy is performed by vNOTES as described Dr BAEKELANDT and this team.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult woman eligible for total hysterectomy for benign lesions with or without bilateral adnexectomy. * Able to give informed consent to participate in research. * Affiliation to a Social Security scheme.
Exclusion criteria
* Pregnant or breastfeeding women * Contraindication to the laparoscopic approach * Contraindication to first vNOTES, in particular: virginity, history of rectal surgery, rectovaginal endometriosis, high active genital infection * Indications for another concomitant surgical procedure (other than procedure on the appendix) * Indication of hysterectomy for malignant lesion. * Any concomitant pathology deemed incompatible with the study. * COVID not cured or SARS-COv2 positivity dating less than 3 days before surgery. * Adult patient protected, under guardianship or curatorship or legal safeguard * Refusal of participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications per or post Operative | one month after surgery | Appearance of a per or post operative complication: bleeding, digestive or urinary sore or infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of pain | Until one month | Quantification of postoperative pain: 6 hours, 24 hours, day 2, 5, 7, 14 and at one month |
| Duration of operation | one day | From skin opening to skin or vaginal closure |
| Assessment of quality of life | Six month | Respond to SF-36 questionnaire to assess and compare quality of life before and after surgery |
| Assessment of satisfaction | Six month | Respond to FSFI questionnaire to assess and compare sexuality before and after surgery |
| Duration of work stoppage | one month | Patients will inquire if they needed to prolong the sick leave. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORSandra CURINIER
University Hospital, Clermont-Ferrand
Outcome results
None listed