Vaginal Natural Orifice Trans-luminal Endoscopic Surgery Salpingectomy for Tubal Sterilization: Clinical Outcomes and Learning Curve Analysis

NCT05581654 | Unknown

• 1 other identifier: LC-V-NOTES
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

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.

Conditions

Tubal Sterilization

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2 years

Secondary Outcomes (10)

• Intraoperative or postoperative complications

  6 weeks

• Postoperative pain scores

  7 days

• Pain drugs intake

  7 days

• Number of days of absence from work

  2 years

• Short Sexual Functioning Scale (SSFS)

  baseline

Study Arms (2)

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.

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.

Procedure: Salpingectomy

Interventions

Salpingectomy PROCEDURE

Salpingectomy by vaginal natural orifice transluminal endoscopic surgery (v-NOTES).

Junior surgeons; Senior surgeons

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years
• Non-prolapsed uterus
• Asking for tubal sterilisation
• Any parity
• Written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jani Jacques: lead

Study Sites (4)

Clinique Saint-Jean

Brussels, 1000, Belgium

RECRUITING

CHU Brugmann

Brussels, 1020, Belgium

RECRUITING

Cliniques Universitaires Saint LUC

Brussels, 1200, Belgium

RECRUITING

CHU Liège - site CHR Liège

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Interventions

Salpingectomy

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Stavros KARAMPELAS, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stavros KARAMPELAS, MD

CONTACT

3224752660; Stavros.KARAMPELAS@chu-brugmann.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Gyneco-Obstetrics Department

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: September 12, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4)