SurgeryHYSTERAMBUNCT06471049
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).
A study testing Benign Hysterectomy in people with Surgery and Gynecologic Disease, run by Elsan at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgery, Gynecologic Disease
- What is being tested?
- Benign Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2024to 4 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Controlled, Randomized 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).
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.
Read more
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.
- Conditions
- Surgery, Gynecologic Disease
- Being tested
- Benign Hysterectomy
- Keywords
- hysterectomy, vnotes, laparoscopy
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benign HysterectomyProcedure or surgery
removal of the uterus
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) | Experimental | Not described Receives: Procedure: Benign Hysterectomy |
| Conventional laparoscopy | Active comparator | Not described Receives: Procedure: Benign Hysterectomy |
| Robot-assisted laparoscopy | Active comparator | Not described Receives: Procedure: Benign Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 hours post-surgery
Secondary outcomes (19)
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
Measured: 6 hours post-surgery
Compare the readmission rate in post-operative night for all patients.
Readmission rate
Measured: 24 hours post-surgery
Compare the readmission rate within 7 days post-surgery for all patients.
Readmission rate
Measured: 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
Measured: 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"
Measured: 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)
Measured: 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
Measured: 1 month post-surgery
Evaluate sequelae for all surgical approaches.
Sequelae of the surgical approach
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 3 months post-surgery
Compare intraoperative bleeding.
Intraoperative bleeding will be evaluated by suction jar decreased by the amount of washing
Measured: Day of surgery
Compare hemoglobin decrease during intervention.
Difference in hemoglobin between pre-operative and post-operative assessment (if applicable)
Measured: Day of surgery
Compare skin-to-skin duration.
Skin-to-skin duration of the procedure between incision and closure
Measured: 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
Measured: 3 months post-surgery
Evaluate the medico-economic value of the use of each technique.
Cost-utility ratio of the use of each technique
Measured: 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start21 May 2024
- Primary completion4 Nov 2024
- Study completion4 Nov 2024
Why it stopped: The study was discontinued for practical reasons, due to logistical and organisational constraints (the investigator centre no longer has a surgical robot).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471049
- Sponsor's protocol ID
- 2023-A02112-43
- Acronym
- HYSTERAMBU
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2024
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Controlled, Randomized 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).
- ClinicalTrials.gov ID
- NCT06471049
- Acronym / sponsor ID
- HYSTERAMBU / 2023-A02112-43
- Conditions
- Surgery, Gynecologic Disease
- Keywords
- hysterectomy, vnotes, laparoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was discontinued for practical reasons, due to logistical and organisational constraints (the investigator centre no longer has a surgical robot).
- Enrolment
- 1 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 21 May 2024 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) | Experimental | Procedure: Benign Hysterectomy |
| Conventional laparoscopy | Active comparator | Procedure: Benign Hysterectomy |
| Robot-assisted laparoscopy | Active comparator | Procedure: Benign Hysterectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benign Hysterectomyremoval of the uterus | Procedure or surgery | Conventional laparoscopy, Robot-assisted laparoscopy, Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) |
Primary outcome
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.
Time frame: 6 hours post-surgery
Success rate of outpatient treatment
19 secondary outcomes
Compare the success rate he success rate of outpatient treatment of the conventional laparoscopic route and the robot-assisted laparoscopic route.
Time frame: 6 hours post-surgery
Compare the readmission rate in post-operative night for all patients.
Time frame: 24 hours post-surgery
Compare the readmission rate within 7 days post-surgery for all patients.
Time frame: 7 days post-surgery
Evaluate the reason for the failure of outpatient treatment
Time frame: 6 hours post-surgery
Compare patient satisfaction for all technique by 5-modal Likert scale
Time frame: 3 months post-surgery
Compare patient satisfaction for all techniques by her opinion on: if this had to be done again (yes/no)
Time frame: 3 months post-surgery
Compare the occurence of intraoperative adverse events and up to one month postoperatively.
Time frame: 1 month post-surgery
Evaluate sequelae for all surgical approaches.
Time frame: 3 months post-surgery
Evaluate post-operative pain by Digital scale.
Time frame: 6 hours post-surgery
Evaluate the use of analgesic.
Time frame: 8 days post-surgery
Compare patient's Hospital Anxiety and Depression Scale score during their treatment.
Time frame: baseline, 1 month post-surgery, 3 months post-surgery
Compare patient's quality of life.
Time frame: baseline, 1 month post-surgery, 3 months post-surgery
Compare the recuperation of sexual function between baseline and 3 months post-surgery.
Time frame: baseline, 3 months post-surgery
Compare the resumption of usual activity and work.
Time frame: 3 months post-surgery
Compare intraoperative bleeding.
Time frame: Day of surgery
Compare hemoglobin decrease during intervention.
Time frame: Day of surgery
Compare skin-to-skin duration.
Time frame: Day of surgery
Compare room occupancy time.
Time frame: 3 months post-surgery
Evaluate the medico-economic value of the use of each technique.
Time frame: 3 months post-surgery
Results and safety
The study was stopped early (reason given: The study was discontinued for practical reasons, due to logistical and organisational constraints (the investigator centre no longer has a surgical robot).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benign Hysterectomy in people with Surgery and Gynecologic Disease, run by Elsan at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was discontinued for practical reasons, due to logistical and organisational constraints (the investigator centre no longer has a surgical robot).). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.