Study Evaluating the Success Rate of Outpatient Management of the Total Benign Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared to Each of the Two Laparoscopic Routes (Conventional and Robot-assisted).
NCT Number: NCT06471049
Acronym: HYSTERAMBU
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Surgery|Gynecologic Disease
Interventions: PROCEDURE: Benign Hysterectomy
Sponsor: Elsan
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 132
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-21
Completion Date: 2027-09-21
Locations: Polyclinique Jean Villar, Bruges, 33520, France

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.

Primary Outcome Measures: 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., Success rate of outpatient treatment, 6 hours post-surgery
Secondary Outcome Measures: Compare the success rate he success rate of outpatient treatment of the conventional laparoscopic route and the robot-assisted laparoscopic route., Success rate of outpatient treatment, 6 hours post-surgery|Compare the readmission rate in post-operative night for all patients., Readmission rate, 24 hours post-surgery|Compare the readmission rate within 7 days post-surgery for all patients., Readmission rate, 7 days post-surgery|Evaluate the reason for the failure of outpatient treatment, 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, 6 hours post-surgery|Compare patient satisfaction for all technique by 5-modal Likert scale, 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", 3 months post-surgery|Compare patient satisfaction for all techniques by her opinion on: if this had to be done again (yes/no), 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), 3 months post-surgery|Compare the occurence of intraoperative adverse events and up to one month postoperatively., Intraoperative and postoperative adverse events related to hysterectomy, 1 month post-surgery|Evaluate sequelae for all surgical approaches., Sequelae of the surgical approach, 3 months post-surgery|Evaluate post-operative pain by Digital scale., Digital pain scale (From 0 to 10) before leaving the recovery room (SSPI) and post-operatively before leaving the hospital, 6 hours post-surgery|Evaluate the use of analgesic., Type of analgesic and number of analgesic tablets actually taken by the patient in the 8 post-operative days., 8 days post-surgery|Compare patient's Hospital Anxiety and Depression Scale score during their treatment., 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., baseline, 1 month post-surgery, 3 months post-surgery|Compare patient's quality of life., 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., baseline, 1 month post-surgery, 3 months post-surgery|Compare the recuperation of sexual function between baseline and 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, baseline, 3 months post-surgery|Compare the resumption of usual activity and work., Resumption of usual activity (duration of incapacity) and professional activity (duration of work stoppage), 3 months post-surgery|Compare intraoperative bleeding., Intraoperative bleeding will be evaluated by suction jar decreased by the amount of washing, Day of surgery|Compare hemoglobin decrease during intervention., Difference in hemoglobin between pre-operative and post-operative assessment (if applicable), Day of surgery|Compare skin-to-skin duration., Skin-to-skin duration of the procedure between incision and closure, Day of surgery|Compare room occupancy time., Room occupancy time defined between the time of entry and exit of the patient from the operating room, 3 months post-surgery|Evaluate the medico-economic value of the use of each technique., Cost-utility ratio of the use of each technique, 3 months post-surgery