vNOTES Transvaginal Endoscopic Surgery Versus Laparoscopy
NCT ID: NCT04324034
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2021-06-03
2026-01-02
Brief Summary
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This study is the first prospective randomized study comparing the vNOTES technique to laparoscopy with postoperative pain assessment for performing a salpingectomy. The hypothesis is that the use of vNOTES transvaginal endoscopic surgery would reduce the post-operative pain of patients compared to laparoscopy in the context of a salpingectomy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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vNOTES
vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is vaginal surgery with a natural approach. The GelPOINT V-path transvaginal access platform is used. It is a device designed to be placed transvaginally to establish a pathway for the insertion of minimally invasive instruments while maintaining insufflation to perform diagnostic or operative procedures. This device also allows a passage for the extraction of operating parts.
vNOTES
vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is vaginal surgery with a natural approach. The GelPOINT V-path transvaginal access platform is used. It is a device designed to be placed transvaginally to establish a pathway for the insertion of minimally invasive instruments while maintaining insufflation to perform diagnostic or operative procedures. This device also allows a passage for the extraction of operating parts.
laparoscopy
conventional laparoscopy
laparoscopy
The surgery by conventional laparoscopy is used
Interventions
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vNOTES
vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is vaginal surgery with a natural approach. The GelPOINT V-path transvaginal access platform is used. It is a device designed to be placed transvaginally to establish a pathway for the insertion of minimally invasive instruments while maintaining insufflation to perform diagnostic or operative procedures. This device also allows a passage for the extraction of operating parts.
laparoscopy
The surgery by conventional laparoscopy is used
Eligibility Criteria
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Inclusion Criteria
* patients with free, informed and signed consent
Exclusion Criteria
* pregnancy or wish for subsequent pregnancy
* lactating women
* intervention in the context of pelvic cancer
* history of uni- or bilateral salpingectomy
* contraindication to laparoscopy
* history of rectal surgery
* endometriosis
* pelvic inflammatory disease
* genital infection
* not eligible for outpatient care
* associated surgical procedure planned during the intervention (hysterectomy, sub-urethral strip, prolapse cure ...)
* participation in another interventional research related to the gynecological sphere
* inability to understand the information given
* a person not affiliated to a social security scheme, or deprived of liberty, or under guardianship.
18 Years
FEMALE
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Hospices Civils de Lyon
Bron, , France
Countries
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Central Contacts
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Facility Contacts
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LAMBLIN Géry
Role: primary
Other Identifiers
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69HCL19_1013
Identifier Type: -
Identifier Source: org_study_id
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