AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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).
Show all 9Show fewer
  • 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.

Stavros KARAMPELAS, MD contact

3224752660

Stavros.KARAMPELAS@chu-brugmann.be

Belgium4 sites, 4 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

    Recruiting

Other trials in Belgium

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.

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 groups in NCT05581654
Study groupRoleWhat they receive
Junior surgeonsExperimentalThe 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 surgeonsActive comparatorThe 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.

  1. 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

  2. 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)
  1. 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

  2. Postoperative pain scores

    Postoperative pain scores measured using a visual analog scale twice a day from day 1 to 7.

    Measured: 7 days

  3. Pain drugs intake

    The total amount of pain drugs taken during the first week following surgery

    Measured: 7 days

  4. Number of days of absence from work

    Number of days of absence from work

    Measured: 2 years

  5. Short Sexual Functioning Scale (SSFS)

    Sexual well-being by self-reporting the Short Sexual Functioning Scale (SSFS).

    Measured: baseline

  6. Short Sexual Functioning Scale (SSFS)

    Sexual well-being by self-reporting the Short Sexual Functioning Scale (SSFS).

    Measured: 3 months after baseline

  7. Short Sexual Functioning Scale (SSFS)

    Sexual well-being by self-reporting the Short Sexual Functioning Scale (SSFS).

    Measured: 6 months after baseline

  8. Pain on sexual intercourse

    Occurrence and severity of pain on sexual intercourse self-reported by the patient by using a simple questionnaire.

    Measured: baseline

  9. 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

  10. 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.

  1. First posted14 Oct 2022
  2. Study start12 Sep 2022
  3. Primary completionMar 2024 (estimated)
  4. Study completionMar 2024 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in