SalpingectomyNOTRANDONCT04324034
vNOTES Transvaginal Endoscopic Surgery Versus Laparoscopy
A study testing vNOTES and laparoscopy in people with Salpingectomy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The feasibility and safety of laparoscopy are no longer to be demonstrated, especially in the field of gynecology, but this technique often causes post-operative pain. New techniques are being developed to overcome the inconvenience of laparoscopy, notably endoscopic transluminal surgery using a natural orifice… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Salpingectomy
- What is being tested?
- vNOTES and laparoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2021to 2 Jan 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned surgery procedure : bilateral salpingectomy for outpatient benign indication
- patients with free, informed and signed consent
Who cannot join
- disorders leading to an unacceptable risk of postoperative complications sought during the interrogation of the patient (disorders of blood coagulation, disorders of the immune system, progressive diseases ....)
- pregnancy or wish for subsequent pregnancy
- lactating women
- intervention in the context of pelvic cancer
- history of uni- or bilateral salpingectomy
- contraindication to laparoscopy
Show all 15Show fewer
- history of rectal surgery
- endometriosis
- pelvic inflammatory disease
- genital infection
- not eligible for outpatient care
- associated surgical procedure planned during the intervention (hysterectomy, sub-urethral strip, prolapse cure ...)
- participation in another interventional research related to the gynecological sphere
- inability to understand the information given
- a person not affiliated to a social security scheme, or deprived of liberty, or under guardianship.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Bron, 69677
LAMBLIN Géry
About this study
Official title: Randomized Study Comparing Endoscopic Transvaginal vNOTES Surgery to Laparoscopy in Terms of Postoperative Pain
The feasibility and safety of laparoscopy are no longer to be demonstrated, especially in the field of gynecology, but this technique often causes post-operative pain. New techniques are being developed to overcome the inconvenience of laparoscopy, notably endoscopic transluminal surgery using a natural orifice (NOTES). It avoids incisions and therefore scarring, and could reduce post-operative pain. It is now developing in the field of transvaginal gynecology (vNOTES).
This study is the first prospective randomized study comparing the vNOTES technique to laparoscopy with postoperative pain assessment for performing a salpingectomy. The hypothesis is that the use of vNOTES transvaginal endoscopic surgery would reduce the post-operative pain of patients compared to laparoscopy in the context of a salpingectomy.
- Conditions
- Salpingectomy
- Being tested
- vNOTES, laparoscopy
- Keywords
- vNOTES, laparoscopy, salpingectomy, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vNOTESDevice
vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is vaginal surgery with a natural approach. The GelPOINT V-path transvaginal access platform is used. It is a device designed to be placed transvaginally to establish a pathway for the insertion of minimally invasive instruments while maintaining insufflation to perform diagnostic or operative procedures. This device also allows a passage for the extraction of operating parts.
laparoscopyProcedure or surgery
The surgery by conventional laparoscopy is used
| Study group | Role | What they receive |
|---|---|---|
| vNOTES | Experimental | vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is vaginal surgery with a natural approach. The GelPOINT V-path transvaginal access platform is used. It is a device designed to be placed transvaginally to establish a pathway for the insertion of minimally invasive instruments while maintaining insufflation to perform diagnostic or operative procedures. This device also allows a passage for the extraction of operating parts. Receives: Device: vNOTES |
| laparoscopy | Active comparator | conventional laparoscopy Receives: Procedure: laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score (VAS)
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
Measured: Day 1 (the day after surgery)
Secondary outcomes (21)
Pain score (VAS)
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 100 mm (unbearable pain)
Measured: Day 0 (Hour 2 post surgery)
Pain score (VAS)
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 100 mm (unbearable pain)
Measured: Day 0 (Hour 6 post surgery)
pain score (VAS)
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 100 mm (unbearable pain)
Measured: Day 7
pain score (QDSA)
Pain score assessed by QDSA short questionnaire (Saint-Antoine Pain Questionnaire) : list of 16 qualifiers to describe pain, score ranging from 0 to 64
Measured: Day 0 (Hour 6 post surgery)
pain score (QDSA)
Pain score assessed by QDSA short questionnaire (Saint-Antoine Pain Questionnaire) : list of 16 qualifiers to describe pain, score ranging from 0 to 64
Measured: Day 1 (the day after surgery)
pain score (QDSA)
Pain score assessed by QDSA short questionnaire (Saint-Antoine Pain Questionnaire) : list of 16 qualifiers to describe pain, score ranging from 0 to 64
Measured: Day 7
ease of performing the technique score (VAS)
Visual analogic scale (VAS) is used to evaluate from 0 (very easy) to 100 mm (very difficult).
Measured: Day 0 (30 minutes after surgery)
duration of surgery
duration of surgery (between incision and closure) in minutes
Measured: Day 0 (30 minutes after surgery)
Surgery complications
Description of all per and postoperative complications
Measured: Month 1
outpatient care
number of patients discharged from hospital on the same day of the intervention
Measured: Day 1
dose of morphine
total dose of morphine (mg) administered in the post-interventional surveillance room
Measured: Day 0 (2 hours post surgery)
dose of analgesic
total administered dose of analgesic supplement (mg) in post-interventional monitoring room
Measured: Day 0 (2 hours post surgery)
duration of analgesic
duration of analgesic treatment (min) in post-interventional monitoring room
Measured: Day 0 (2 hours post surgery)
dose of analgesic
total administered dose of analgesics (mg) during the hospital stay
Measured: Day 0 (8 hours post surgery)
duration of analgesic
duration of analgesic treatment (hours) during the hospital stay
Measured: Day 0 (8 hours post surgery)
dose of analgesic
total administered dose of analgesics (mg) during the month following the surgery
Measured: month 1
duration of analgesic
duration of analgesic treatment (days) during the month following the surgery
Measured: month 1
quality of life score
assessed by the questionnaire SF-12 (abridged version of the Medical Outcomes Study Short-Form General Health Survey SF-36). It allows to obtain 2 scores: mental and social score (from 5.89058 to 71.966825) and physical score (from 9.94738 to 70.02246). The average of this scores in the general population is 50.
Measured: month 1
symptom improvement score
assessed by the questionnaire PGI-I (Patient Global Impression of Improvement ) (from 1 "much better" to 7 "much worse")
Measured: month 1
patient satisfaction score
Visual analogic scale (VAS) is used to evaluate from 0 (not at all satisfied) to 100 mm (very satisfied).
Measured: month 1
patient management costs
Patient management costs according to the two surgical strategies
Measured: month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start3 Jun 2021
- Primary completion2 Jan 2026 (estimated)
- Study completion2 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SalpingectomyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324034
- Sponsor's protocol ID
- 69HCL19_1013
- Acronym
- NOTRANDO
- Status last verified
- Feb 2023
- First submitted
- 25 Mar 2020
- Last updated
- 8 Feb 2023
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Comparing Endoscopic Transvaginal vNOTES Surgery to Laparoscopy in Terms of Postoperative Pain
- ClinicalTrials.gov ID
- NCT04324034
- Acronym / sponsor ID
- NOTRANDO / 69HCL19_1013
- Conditions
- Salpingectomy
- Keywords
- vNOTES, laparoscopy, salpingectomy, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 2 Jan 2026 (estimated)
- Study completion
- 2 Jan 2026 (estimated)
- First posted
- 27 Mar 2020 (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.
The feasibility and safety of laparoscopy are no longer to be demonstrated, especially in the field of gynecology, but this technique often causes post-operative pain. New techniques are being developed to overcome the inconvenience of laparoscopy, notably endoscopic transluminal surgery using a natural orifice (NOTES). It avoids incisions and therefore scarring, and could reduce post-operative pain. It is now developing in the field of transvaginal gynecology (vNOTES).
This study is the first prospective randomized study comparing the vNOTES technique to laparoscopy with postoperative pain assessment for performing a salpingectomy. The hypothesis is that the use of vNOTES transvaginal endoscopic surgery would reduce the post-operative pain of patients compared to laparoscopy in the context of a salpingectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vNOTES | Experimental | Device: vNOTESvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is vaginal surgery with a natural approach. The GelPOINT V-path transvaginal access platform is used. It is a device designed to be placed transvaginally to establish a pathway for the insertion of minimally invasive instruments while maintaining insufflation to perform diagnostic or operative procedures. This device also allows a passage for the extraction of operating parts. |
| laparoscopy | Active comparator | Procedure: laparoscopyconventional laparoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- planned surgery procedure : bilateral salpingectomy for outpatient benign indication
- patients with free, informed and signed consent
Key exclusion criteria (15 listed)
- disorders leading to an unacceptable risk of postoperative complications sought during the interrogation of the patient (disorders of blood coagulation, disorders of the immune system, progressive diseases ....)
- pregnancy or wish for subsequent pregnancy
- lactating women
- intervention in the context of pelvic cancer
- history of uni- or bilateral salpingectomy
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 |
|---|---|---|
| vNOTESvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is vaginal surgery with a natural approach. The GelPOINT V-path transvaginal access platform is used. It is a device designed to be placed transvaginally to establish a pathway for the insertion of minimally invasive instruments while maintaining insufflation to perform diagnostic or operative procedures. This device also allows a passage for the extraction of operating parts. | Device | vNOTES |
| laparoscopyThe surgery by conventional laparoscopy is used | Procedure or surgery | laparoscopy |
Primary outcome
Pain score (VAS)
Time frame: Day 1 (the day after surgery)
Visual analogic scale (VAS) is used to evaluate from 0 (no pain) to 10 (unbearable pain)
21 secondary outcomes
Pain score (VAS)
Time frame: Day 0 (Hour 2 post surgery)
Pain score (VAS)
Time frame: Day 0 (Hour 6 post surgery)
pain score (VAS)
Time frame: Day 7
pain score (QDSA)
Time frame: Day 0 (Hour 6 post surgery)
pain score (QDSA)
Time frame: Day 1 (the day after surgery)
pain score (QDSA)
Time frame: Day 7
ease of performing the technique score (VAS)
Time frame: Day 0 (30 minutes after surgery)
duration of surgery
Time frame: Day 0 (30 minutes after surgery)
Surgery complications
Time frame: Month 1
outpatient care
Time frame: Day 1
dose of morphine
Time frame: Day 0 (2 hours post surgery)
dose of analgesic
Time frame: Day 0 (2 hours post surgery)
duration of analgesic
Time frame: Day 0 (2 hours post surgery)
dose of analgesic
Time frame: Day 0 (8 hours post surgery)
duration of analgesic
Time frame: Day 0 (8 hours post surgery)
dose of analgesic
Time frame: month 1
duration of analgesic
Time frame: month 1
quality of life score
Time frame: month 1
symptom improvement score
Time frame: month 1
patient satisfaction score
Time frame: month 1
patient management costs
Time frame: month 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Salpingectomy
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Active, not recruiting
Prophylactic Salpingectomy With Delayed Oophorectomy
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HYbrid RObotic Surgery in Gynecology
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vNOTES and laparoscopy in people with Salpingectomy, run by Hospices Civils de Lyon 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 2 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gery LAMBLIN, Pr ((0)4 72 35 58 71 ext. +33, gery.lamblin@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (VAS) (time frame: Day 1 (the day after 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 8 Feb 2023.