Tubal SterilizationNCT05581654
Vaginal Natural Orifice Trans-luminal Endoscopic Surgery Salpingectomy for Tubal Sterilization: Clinical Outcomes and Learning Curve Analysis
A study testing Salpingectomy in people with Tubal Sterilization, run by Jani Jacques at 4 sites in Belgium.
Trial summary
The evolution from classical open surgery to laparoscopic surgery has led to a significant reduction of morbidity and mortality. Newer advances such as development of single port laparoscopic surgery and scarless Natural Orifice Transluminal Endoscopic Surgery (NOTES) have moved forward the practice in "Minimally… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Tubal Sterilization
- What is being tested?
- Salpingectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesBelgium
- Study dates
- 12 Sep 2022to Mar 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 - 50 years
- Non-prolapsed uterus
- Asking for tubal sterilisation
- Any parity
- Written informed consent
Who cannot join
- History of pelvic inflammatory disease.
- Recto-vaginal endometriosis.
- Suspicion of genital tract malignancy.
- Active lower genital tract infection.
- History of rectal surgery.
- Stage III or IV Uterine prolapse (defined by the International Continence Society classification).
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- Complete obliteration of the posterior douglas pouch determined by pelvic examination.
- Virginity.
- Failure to provide written informed consent.
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites, 4 recruiting
- Recruiting
Clinique Saint-Jean
Brussels, 1000
Nathanaël DUBOIS, MD, ndubois@clstjean.be
- Recruiting
CHU Brugmann
Brussels, 1020
Stavros KARAMPELAS, MD, Stavros.KARAMPELAS@chu-brugmann.be
- Recruiting
Cliniques Universitaires Saint LUC
Brussels, 1200
Mathieu LUYCKX, MD, mathieu.luyckx@saintluc.uclouvain.be
- Recruiting
CHU Liège - site CHR Liège
Liège, 4000
François CLOSON, f.closon@chuliege.be
About this study
Official title: Vaginal Natural Orifice Trans-luminal Endoscopic Surgery (vNOTES) Salpingectomy for Tubal Sterilization: Clinical Outcomes and Learning Curve Analysis: A Multicentre Prospective Study
The evolution from classical open surgery to laparoscopic surgery has led to a significant reduction of morbidity and mortality.
Newer advances such as development of single port laparoscopic surgery and scarless Natural Orifice Transluminal Endoscopic Surgery (NOTES) have moved forward the practice in "Minimally Invasive Surgery".
Read more
Recently, clinical application of vNOTES has broadened significantly in the field of gynaecological surgery.
As the application of vNOTES is increasing, it is deemed mandatory to assess the clinical outcomes and the learning curve (LC) of this novel technique.
There is a paucity of reports in the literature analysing prospectively the clinical outcomes the LC of vNOTES in the gynaecological field.
To the investigator's knowledge, there is no published prospective multicentre study that aims to evaluate the peri- and postoperative outcomes and the LC of salpingectomy for tubal sterilization by the technique of vNOTES.
Read the detailed description
The evolution from traditional open surgery to laparoscopic surgery has led to a significant reduction of morbidity and mortality. Newer advances such as development of single port laparoscopic surgery and scarless Natural Orifice Transluminal Endoscopic Surgery (NOTES) with or without robot assistance have moved forward the practice in "Minimally Invasive Surgery".
Described for the first time in 2004 at John Hopkins University in an experimental porcine model, NOTES is a surgical technique in which the natural orifices (mouth, vagina, urethra and rectum) are used as access routes to the peritoneal cavity for endoscopic surgery with no abdominal incisions.
Clinical application of NOTES has been initially reported in general surgical procedures where Trans-gastric Appendectomy and Cholecystectomy have been performed using the mouth and the stomach as the access route.
The technique seems to be feasible and safe when performed by experienced surgeons. Favourable outcomes such as reduced post-operative pain, a shorter length of hospital stay, improved cosmetic results due to scar-free surgery and reduced wound complications at trocar insertion sites, promote the increasing use of this new surgical technique.
Although NOTES may be performed through various entries including the stomach, oesophagus, bladder and rectum, NOTES procedures in women have been commonly performed through the vagina as this allows direct access to the abdominal cavity. Therefore, trans-vaginal NOTES (vNOTES) has gained popularity among general surgeons, urologists and gastroenterologists over the past decade and was adopted in various surgical procedures, varying from cholecystectomy, appendectomy, sigmoidectomy, nephrectomy, splenectomy, liver resection and sleeve gastrectomy.
Recently, clinical application of vNOTES has broadened significantly in the field of gynaecological surgery. The feasibility and safety of vNOTES in this specialty was firstly demonstrated in 2012. This event represented the key milestone in the evolution of vNOTES for gynaecologic procedures. Based on the current reports, we know that many of these procedures, such as oophorectomy, salpingectomy, adnexectomy, hysterectomy and many other more complex surgeries can be performed using vNOTES by the majority of surgeons who have adequate skills in performing laparoscopy.
As the application of vNOTES is increasing, it is deemed mandatory to assess the learning curve (LC) of this novel technique. This is particularly important in surgery where new skills must be acquired constantly, safely and proficiently. It would be useful to know how many vNOTES procedures a surgeon may have to carry out before reaching an adequate level of safety and efficiency. Furthermore, a correct understanding of the LC is essential in randomised control trials comparing vNOTES with alternative types of surgery in order to reach valid conclusions.
There is a paucity of reports in the literature analysing the LC of vNOTES. The "learning curves" for performing vNOTES hysterectomy and adnexal surgery have been previously assessed by retrospective studies, each conducted on a single surgeon basis and in a single institution (19-21). In a report published in June 2020, Lowenstein et al were among the first researchers that evaluated prospectively the learning curve of mastering the skills to perform vNOTES hysterectomy and uterosacral ligament suspension in two different centres.
To the investigators knowledge, there is no published prospective multicentre study that aims to evaluate the feasibility, the LC, the peri- and postoperative outcomes of salpingectomy for tubal sterilization by the technique of vNOTES.
- Conditions
- Tubal Sterilization
- Being tested
- Salpingectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalpingectomyProcedure or surgery
Salpingectomy by vaginal natural orifice transluminal endoscopic surgery (v-NOTES).
| Study group | Role | What they receive |
|---|---|---|
| Junior surgeons | Experimental | The surgeons will be divided into 2 arms based on their surgical experience time: less than 5 years (junior surgeons) and more than 5 years (senior surgeons). The learning curve analysis will include 30 procedures for each surgeon group in each centre. For ethical reasons, all the junior surgeons will first assist the senior surgeons in performing vNOTES salpingectomy, as first assistant in at least 15 procedures, before starting to perform them as operators. Receives: Procedure: Salpingectomy |
| Senior surgeons | Active comparator | The surgeons will be divided into 2 arms based on their surgical experience time: less than 5 years (junior surgeons) and more than 5 years (senior surgeons). The learning curve analysis will include 30 procedures for each surgeon group in each centre. Receives: Procedure: Salpingectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women successfully operated (salpingectomy) for tubal sterilization using vNOTES technique as a one day procedure.
The proportion of women who were successfully operated (salpingectomy) for tubal sterilization using vNOTES technique as a one day procedure will be measured as the primary outcome of effectiveness.
Successful salpingectomy for tubal sterilization using vNOTES technique as a one day procedure is defined by:
- Complete retrieval of fallopian tube(s) (pathological confirmation).
- No conversion into laparoscopy or open surgery.
- Discharge from hospital on day 0 post-operatively.
Measured: 2 years
Learning Curve Assessment.
The Assessment of the learning curve of salpingectomy by the technique of vNOTES in young and experienced surgeons is another primary outcome of our study.
Measured: 2 years
Secondary outcomes (10)
Intraoperative or postoperative complications
Intraoperative or postoperative complications detected during the first 6 weeks of surgery and classified based on the Clavien-Dindo classification.
Measured: 6 weeks
Postoperative pain scores
Postoperative pain scores measured using a visual analog scale twice a day from day 1 to 7.
Measured: 7 days
Pain drugs intake
The total amount of pain drugs taken during the first week following surgery
Measured: 7 days
Number of days of absence from work
Number of days of absence from work
Measured: 2 years
Short Sexual Functioning Scale (SSFS)
Sexual well-being by self-reporting the Short Sexual Functioning Scale (SSFS).
Measured: baseline
Short Sexual Functioning Scale (SSFS)
Sexual well-being by self-reporting the Short Sexual Functioning Scale (SSFS).
Measured: 3 months after baseline
Short Sexual Functioning Scale (SSFS)
Sexual well-being by self-reporting the Short Sexual Functioning Scale (SSFS).
Measured: 6 months after baseline
Pain on sexual intercourse
Occurrence and severity of pain on sexual intercourse self-reported by the patient by using a simple questionnaire.
Measured: baseline
Pain on sexual intercourse
Occurrence and severity of pain on sexual intercourse self-reported by the patient by using a simple questionnaire.
Measured: 3 months after baseline
Pain on sexual intercourse
Occurrence and severity of pain on sexual intercourse self-reported by the patient by using a simple questionnaire.
Measured: 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start12 Sep 2022
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tubal SterilizationStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jani Jacques
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jani Jacques, Brugmann University Hospital
- Investigators
- Stavros KARAMPELAS, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581654
- Sponsor's protocol ID
- LC-V-NOTES
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 14 Oct 2022
- 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 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Natural Orifice Trans-luminal Endoscopic Surgery (vNOTES) Salpingectomy for Tubal Sterilization: Clinical Outcomes and Learning Curve Analysis: A Multicentre Prospective Study
- ClinicalTrials.gov ID
- NCT05581654
- Acronym / sponsor ID
- LC-V-NOTES
- Conditions
- Tubal Sterilization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Jani JacquesUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 14 Oct 2022 (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 evolution from classical open surgery to laparoscopic surgery has led to a significant reduction of morbidity and mortality.
Newer advances such as development of single port laparoscopic surgery and scarless Natural Orifice Transluminal Endoscopic Surgery (NOTES) have moved forward the practice in "Minimally Invasive Surgery".
Recently, clinical application of vNOTES has broadened significantly in the field of gynaecological surgery.
As the application of vNOTES is increasing, it is deemed mandatory to assess the clinical outcomes and the learning curve (LC) of this novel technique.
There is a paucity of reports in the literature analysing prospectively the clinical outcomes the LC of vNOTES in the gynaecological field.
To the investigator's knowledge, there is no published prospective multicentre study that aims to evaluate the peri- and postoperative outcomes and the LC of salpingectomy for tubal sterilization by the technique of vNOTES.
Detailed description
The evolution from traditional open surgery to laparoscopic surgery has led to a significant reduction of morbidity and mortality. Newer advances such as development of single port laparoscopic surgery and scarless Natural Orifice Transluminal Endoscopic Surgery (NOTES) with or without robot assistance have moved forward the practice in "Minimally Invasive Surgery".
Described for the first time in 2004 at John Hopkins University in an experimental porcine model, NOTES is a surgical technique in which the natural orifices (mouth, vagina, urethra and rectum) are used as access routes to the peritoneal cavity for endoscopic surgery with no abdominal incisions.
Clinical application of NOTES has been initially reported in general surgical procedures where Trans-gastric Appendectomy and Cholecystectomy have been performed using the mouth and the stomach as the access route.
The technique seems to be feasible and safe when performed by experienced surgeons. Favourable outcomes such as reduced post-operative pain, a shorter length of hospital stay, improved cosmetic results due to scar-free surgery and reduced wound complications at trocar insertion sites, promote the increasing use of this new surgical technique.
Although NOTES may be performed through various entries including the stomach, oesophagus, bladder and rectum, NOTES procedures in women have been commonly performed through the vagina as this allows direct access to the abdominal cavity. Therefore, trans-vaginal NOTES (vNOTES) has gained popularity among general surgeons, urologists and gastroenterologists over the past decade and was adopted in various surgical procedures, varying from cholecystectomy, appendectomy, sigmoidectomy, nephrectomy, splenectomy, liver resection and sleeve gastrectomy.
Recently, clinical application of vNOTES has broadened significantly in the field of gynaecological surgery. The feasibility and safety of vNOTES in this specialty was firstly demonstrated in 2012. This event represented the key milestone in the evolution of vNOTES for gynaecologic procedures. Based on the current reports, we know that many of these procedures, such as oophorectomy, salpingectomy, adnexectomy, hysterectomy and many other more complex surgeries can be performed using vNOTES by the majority of surgeons who have adequate skills in performing laparoscopy.
As the application of vNOTES is increasing, it is deemed mandatory to assess the learning curve (LC) of this novel technique. This is particularly important in surgery where new skills must be acquired constantly, safely and proficiently. It would be useful to know how many vNOTES procedures a surgeon may have to carry out before reaching an adequate level of safety and efficiency. Furthermore, a correct understanding of the LC is essential in randomised control trials comparing vNOTES with alternative types of surgery in order to reach valid conclusions.
There is a paucity of reports in the literature analysing the LC of vNOTES. The "learning curves" for performing vNOTES hysterectomy and adnexal surgery have been previously assessed by retrospective studies, each conducted on a single surgeon basis and in a single institution (19-21). In a report published in June 2020, Lowenstein et al were among the first researchers that evaluated prospectively the learning curve of mastering the skills to perform vNOTES hysterectomy and uterosacral ligament suspension in two different centres.
To the investigators knowledge, there is no published prospective multicentre study that aims to evaluate the feasibility, the LC, the peri- and postoperative outcomes of salpingectomy for tubal sterilization by the technique of vNOTES.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Junior surgeons | Experimental | Procedure: SalpingectomyThe surgeons will be divided into 2 arms based on their surgical experience time: less than 5 years (junior surgeons) and more than 5 years (senior surgeons). The learning curve analysis will include 30 procedures for each surgeon group in each centre. For ethical reasons, all the junior surgeons will first assist the senior surgeons in performing vNOTES salpingectomy, as first assistant in at least 15 procedures, before starting to perform them as operators. |
| Senior surgeons | Active comparator | Procedure: SalpingectomyThe surgeons will be divided into 2 arms based on their surgical experience time: less than 5 years (junior surgeons) and more than 5 years (senior surgeons). The learning curve analysis will include 30 procedures for each surgeon group in each centre. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18 - 50 years
- Non-prolapsed uterus
- Asking for tubal sterilisation
- Any parity
- Written informed consent
Key exclusion criteria (9 listed)
- History of pelvic inflammatory disease.
- Recto-vaginal endometriosis.
- Suspicion of genital tract malignancy.
- Active lower genital tract infection.
- History of rectal surgery.
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 |
|---|---|---|
| SalpingectomySalpingectomy by vaginal natural orifice transluminal endoscopic surgery (v-NOTES). | Procedure or surgery | Junior surgeons, Senior surgeons |
Primary outcome
Proportion of women successfully operated (salpingectomy) for tubal sterilization using vNOTES technique as a one day procedure.
Time frame: 2 years
The proportion of women who were successfully operated (salpingectomy) for tubal sterilization using vNOTES technique as a one day procedure will be measured as the primary outcome of effectiveness. Successful salpingectomy for tubal sterilization using vNOTES technique as a one day procedure is defined by: * Complete retrieval of fallopian tube(s) (pathological confirmation). * No conversion into laparoscopy or open surgery. * Discharge from hospital on day 0 post-operatively.
Learning Curve Assessment.
Time frame: 2 years
The Assessment of the learning curve of salpingectomy by the technique of vNOTES in young and experienced surgeons is another primary outcome of our study.
10 secondary outcomes
Intraoperative or postoperative complications
Time frame: 6 weeks
Postoperative pain scores
Time frame: 7 days
Pain drugs intake
Time frame: 7 days
Number of days of absence from work
Time frame: 2 years
Short Sexual Functioning Scale (SSFS)
Time frame: baseline
Short Sexual Functioning Scale (SSFS)
Time frame: 3 months after baseline
Short Sexual Functioning Scale (SSFS)
Time frame: 6 months after baseline
Pain on sexual intercourse
Time frame: baseline
Pain on sexual intercourse
Time frame: 3 months after baseline
Pain on sexual intercourse
Time frame: 6 months after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- 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.
Stavros KARAMPELAS, MD principal investigator
CHU Brugmann
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salpingectomy in people with Tubal Sterilization, run by Jani Jacques at 4 sites in Belgium.
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 5 inclusion and 9 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 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. 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 Stavros KARAMPELAS, MD (3224752660, Stavros.KARAMPELAS@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women successfully operated (salpingectomy) for tubal sterilization using vNOTES technique as a one day procedure. (time frame: 2 years). The study lists 2 primary outcomes in all. 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 14 Oct 2022.