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vNOTES Transvaginal Endoscopic Surgery Versus Laparoscopy

vNOTES Transvaginal Endoscopic Surgery Versus Laparoscopy

Recruiting
18 years and older
Female
Phase N/A

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Overview

The feasibility and safety of laparoscopy are no longer to be demonstrated, especially in the field of gynecology, but this technique often causes post-operative pain. New techniques are being developed to overcome the inconvenience of laparoscopy, notably endoscopic transluminal surgery using a natural orifice (NOTES). It avoids incisions and therefore scarring, and could reduce post-operative pain. It is now developing in the field of transvaginal gynecology (vNOTES).

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.

Eligibility

Inclusion Criteria:

  • planned surgery procedure : bilateral salpingectomy for outpatient benign indication
  • patients with free, informed and signed consent

Exclusion Criteria:

  • disorders leading to an unacceptable risk of postoperative complications sought during the interrogation of the patient (disorders of blood coagulation, disorders of the immune system, progressive diseases ....)
  • 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.

Study details
    Salpingectomy

NCT04324034

Hospices Civils de Lyon

26 January 2024

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