Vaginal Natural Orifice Trans-luminal Endoscopic Surgery (vNOTES) Salpingectomy for Tubal Sterilization: Clinical Outcomes and Learning Curve Analysis: A Multicentre Prospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 240
- Locations
- 4
- Primary Endpoint
- Proportion of women successfully operated (salpingectomy) for tubal sterilization using vNOTES technique as a one day procedure.
Study Overview
Brief 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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 - 50 years
- •Non-prolapsed uterus
- •Asking for tubal sterilisation
- •Any parity
- •Written informed consent
Exclusion Criteria
- •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).
- •Complete obliteration of the posterior douglas pouch determined by pelvic examination.
- •Virginity.
- •Failure to provide written informed consent.
Arms & Interventions
Junior surgeons
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.
Intervention: Salpingectomy (Procedure)
Senior surgeons
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.
Intervention: Salpingectomy (Procedure)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of days of absence from work(2 years)
- Short Sexual Functioning Scale (SSFS)(6 months after baseline)
- Intraoperative or postoperative complications(6 weeks)
- Postoperative pain scores(7 days)
- Pain drugs intake(7 days)
- Pain on sexual intercourse(6 months after baseline)
- Short Sexual Functioning Scale (SSFS)(baseline)
- Short Sexual Functioning Scale (SSFS)(3 months after baseline)
- Pain on sexual intercourse(baseline)
- Pain on sexual intercourse(3 months after baseline)
Investigators
Jani Jacques
Head of Gyneco-Obstetrics Department
Brugmann University Hospital