Gynecologic Disease, Surgery
Conditions
Keywords
hysterectomy, vnotes, laparoscopy
Brief summary
Benign total hysterectomy is one of the most commonly performed gynecological surgery. Conventionally performed by a classical surgical approach, it is now provided routinely and for several years by laparoscopy and more recently by Robotic-Assisted Laparoscopy. A third minimally invasive option is currently being developed and proposed to avoid trans-peritoneal access, using a vaginal trans-laparoscopic technique, defined by the name V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery). These minimally invasive approaches have simplified this intervention on many surgical and anesthetic parameters (signing, surgical trauma, pain and post-operative ileus, recovery of autonomy) and consider possible management in the outpatient sector. This study aims at enrolling women for which a total hysterectomy with or without annexectomy for the treatment of a benign pathology must be scheduled. The objective of the study is to compare the success rate of outpatient treatment of the V-Notes route and the conventional laparoscopic route and to compare the success rate of outpatient treatment of the V-Notes route and the laparoscopic route assisted robot.
Interventions
PROCEDUREBenign Hysterectomy
removal of the uterus
Sponsors
Elsan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participant aged 18 years old and over * Participant for whom a total hysterectomy with or without adnexectomy for the treatment of a benign pathology must be scheduled * Participant with no contraindication to being operated on by one of the three approaches under study (conventional laparoscopy, V-Notes, robot-assisted laparoscopy) * Patient eligible for outpatient treatment * Participant affiliated or beneficiary of a social security regimen * Participant having been informed and having given her free, informed and written consent (at the latest on the day of inclusion and before any examination required by the research)
Exclusion criteria
* Participant with endometriosis with procedure associated with hysterectomy (digestive procedure, extended adhesiolysis, or other procedure) * Participant whose physical and/or psychological health is severely impaired, which according to the investigator may affect the participant's understanding and compliance with the study * Participant in another research * Participant in a period of exclusion from another research still in progress at the time of inclusion * Protected participant: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision * Patient hospitalized without consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the success rate of outpatient treatment of the V-Notes route and the conventional laparoscopic route and to compare the success rate of outpatient treatment of the V-Notes route and the robot-assisted laparoscopic route. | 6 hours post-surgery | Success rate of outpatient treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the success rate he success rate of outpatient treatment of the conventional laparoscopic route and the robot-assisted laparoscopic route. | 6 hours post-surgery | Success rate of outpatient treatment |
| Compare the readmission rate in post-operative night for all patients. | 24 hours post-surgery | Readmission rate |
| Compare the readmission rate within 7 days post-surgery for all patients. | 7 days post-surgery | Readmission rate |
| Evaluate the reason for the failure of outpatient treatment | 6 hours post-surgery | Rate of failure of outpatient treatment coming from the patient Rate of failure of outpatient treatment coming from the surgeon Rate of failure of outpatient treatment coming from the entourage Rate of failure of outpatient treatment coming from other reason |
| Compare patient satisfaction for all technique by 5-modal Likert scale | 3 months post-surgery | Satisfaction assessed by 5-modal Likert scale : "Are you satisfied with the outpatient management of benign total hysterectomy? Very dissatisfied/ dissatisfied/ neither satisfied nor dissatisfied/ satisfied/ very satisfied" |
| Compare patient satisfaction for all techniques by her opinion on: if this had to be done again (yes/no) | 3 months post-surgery | Satisfaction assessed by the following question : If you had to do it again, would you accept outpatient care for this type of surgery? (yes/no) |
| Compare the occurence of intraoperative adverse events and up to one month postoperatively. | 1 month post-surgery | Intraoperative and postoperative adverse events related to hysterectomy |
| Evaluate sequelae for all surgical approaches. | 3 months post-surgery | Sequelae of the surgical approach |
| Evaluate post-operative pain by Digital scale. | 6 hours post-surgery | Digital pain scale (From 0 to 10) before leaving the recovery room (SSPI) and post-operatively before leaving the hospital |
| Evaluate the use of analgesic. | 8 days post-surgery | Type of analgesic and number of analgesic tablets actually taken by the patient in the 8 post-operative days. |
| Compare patient's Hospital Anxiety and Depression Scale score during their treatment. | baseline, 1 month post-surgery, 3 months post-surgery | HADS (Hospital Anxiety and Depression Scale) is a self questionnaire including 14 items which identifies and quantifies the depression and anxiety from which a person suffers. 7 questions relate to anxiety (total A) and 7 others to the depressive dimension (total D), allowing thus obtaining two scores (maximum score of each score = 21). A higher score indicates higher distress. |
| Compare patient's quality of life. | baseline, 1 month post-surgery, 3 months post-surgery | The patient's quality of life will be measured by EQ-5D-5L. It essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. |
| Compare the recuperation of sexual function between baseline and 3 months post-surgery. | baseline, 3 months post-surgery | PISQ-12 is a validated and reliable short form that evaluates sexual function in women with urinary incontinence and/or pelvic organ prolapse |
| Compare the resumption of usual activity and work. | 3 months post-surgery | Resumption of usual activity (duration of incapacity) and professional activity (duration of work stoppage) |
| Compare intraoperative bleeding. | Day of surgery | Intraoperative bleeding will be evaluated by suction jar decreased by the amount of washing |
| Compare hemoglobin decrease during intervention. | Day of surgery | Difference in hemoglobin between pre-operative and post-operative assessment (if applicable) |
| Compare skin-to-skin duration. | Day of surgery | Skin-to-skin duration of the procedure between incision and closure |
| Compare room occupancy time. | 3 months post-surgery | Room occupancy time defined between the time of entry and exit of the patient from the operating room |
| Evaluate the medico-economic value of the use of each technique. | 3 months post-surgery | Cost-utility ratio of the use of each technique |
Countries
France
Outcome results
None listed