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

NCT05581654 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2022-10-14

No results posted yet for this study

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

Interventions

PROCEDURE

Salpingectomy

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

Sponsors & Collaborators

  • Jani Jacques

    lead OTHER

Principal Investigators

  • Stavros KARAMPELAS, MD · CHU Brugmann

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-12
Primary Completion
2024-03-31
Completion
2024-03-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05581654 on ClinicalTrials.gov