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vNOTES in Elective Bilateral Salpingectomy for Sterilization

NCT04809428 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 98

Last updated 2021-06-11

No results posted yet for this study

Summary

Objective: To compare the vNOTES approach versus conventional laparoscopic approach to be used in elective bilateral salpingectomy for sterilisation as an opportunistic cancer prevention strategy.

Study design: Prospective cohort, two-centred trial. Study population: All women aged over 18 who are planned to undergo for definitive surgical sterilisation regardless of parity with a non-prolapsed uterus.

Primary outcomes: (1) Patient satisfaction (at 1st week and 1st month of the surgery) measured by The Patient Global Imression of Improvement (PGI-I), (2) Postoperative early pain (Visual Analog Score (VAS) at 6th and 24th hours of the surgery).

Secondary outcomes: (1) Conversion to laparoscopy or laparotomy, (2) duration of the procedure, (3)total amount of analgesics used, (4) New-onset dyspareunia at first coitus measured by the Pain subdomain of Female Sexual Function Index (FSFI), (5) intraoperative complications, (6) postoperative complications

Conditions

  • Sterility, Female

Interventions

PROCEDURE

vNOTES salpingectomy

Surgical removal of both salpinx by vNOTES with using a 3-cm of posterior colpotomy and either glove port or Gel point V path. Colpotomy will be closed with using 2.0 rapid vicryl.

PROCEDURE

Laparoscopic salpingectomy

Surgical removal of both salpinx by conventional laparoscopy in a standardised fashion: with using one 10-mm umbilical and two 5-mm lateral ports.

Sponsors & Collaborators

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

    collaborator OTHER_GOV

  • Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

    lead OTHER

Principal Investigators

  • Cihan Kaya, MD · Bakirkoy Sadi Konuk Training and Research Hospital

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-12
Primary Completion
2021-05-09
Completion
2021-05-09

Countries

  • Turkey (Türkiye)

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 NCT04809428 on ClinicalTrials.gov