vNOTES in Elective Bilateral Salpingectomy for Sterilization

NCT04809428 | Completed

• 1 other identifier: vNOTES Salpingectomy
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

vNOTES; Scarless surgery; cancer prevention

Outcome Measures

Primary Outcomes (4)

• Patient satisfaction at first week

  Patient satisfaction will be measured with Patient Global Impression of Improvement (PGI-I). It is scored as: Very much better (1), Much better (2), A little better (3), No change (4), A little worse (5), Much worse (6), Very much worse (7). Patient reported as Very much better or much better will be regarded as satisfied.

  The first week after the surgical procedure

• Patient satisfaction at first month

  Patient satisfaction will be measured with Patient Global Impression of Improvement (PGI-I). It is scored as: Very much better (1), Much better (2), A little better (3), No change (4), A little worse (5), Much worse (6), Very much worse (7). Patient reported as Very much better or much better will be regarded as satisfied.

  The first month after the surgical procedure

• Postoperative pain at 6th hours

  Postoperative pain scores will be measured with using Visual Analogue Score (VAS) as self-reported by the participating women. The VAS scores range from 0= no pain to 10= worst imaginable pain.

  At the 6th hours after the surgical procedure

• Postoperative pain at 24th hours

  Postoperative pain scores will be measured with using Visual Analogue Score (VAS) as self-reported by the participating women. The VAS scores range from 0= no pain to 10= worst imaginable pain.

  At the 24th hours after the surgical procedure

Secondary Outcomes (6)

• Dyspareunia

  At 1st month after the surgical procedure

• Duration of the surgical procedure

  Intraoperative

• Conversion

  Intraoperative

• Need of Analgesics

  Postoperative, 24 hours

• Intraoperative complications

  Intraoperative

Study Arms (2)

vNOTES Salpingectomy

Elective bilateral salpingectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery approach

Procedure: vNOTES salpingectomy

LS Salpingectomy

Elective bilateral salpingectomy by conventional laparoscopy

Procedure: Laparoscopic salpingectomy

Interventions

vNOTES salpingectomy PROCEDURE

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.

vNOTES Salpingectomy

Laparoscopic salpingectomy PROCEDURE

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

LS Salpingectomy

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women seeking for definitive surgical sterilization who prefers salpingectomy over tubal ligation due to its possible cancer risk reduction effect.

You may qualify if:

• Women aged over 18 years regardless of parity with a non-prolapsed uterus
• Patients who are indicated or seek for definitive surgical sterilisation
• Patients who prefers salpingectomy over tubal ligation after considering its possible cancer prevention effect
• Written informed consent obtained prior to surgery

You may not qualify if:

• Any malignancy
• Suspected rectovaginal endometriosis
• History of pelvic inflammatory disease, pouch of Douglas abscess
• Being Virgo or Pregnant
• Failure to provide written informed consent prior to surgery

Sponsors & Collaborators

• Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital: lead
• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: collaborator

Study Sites (2)

Bakirkoy Sadi Konuk Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Sehit Prof Dr Ilhan Varank Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• Kaya C, Alay I, Cengiz H, Baghaki S, Aslan O, Ekin M, Yasar L. Conventional Laparoscopy or Vaginally Assisted Natural Orifice Transluminal Endoscopic Surgery for Adnexal Pathologies: A Paired Sample Cross-Sectional Study. J Invest Surg. 2021 Nov;34(11):1185-1190. doi: 10.1080/08941939.2020.1789246. Epub 2020 Jul 7.

  PMID: 32633168 BACKGROUND

• Yassa M, Pulatoglu C. Patients' perceptions toward and the driving factors of decision-making for opportunistic bilateral salpingectomy at the time of cesarean section. Turk J Obstet Gynecol. 2020 Jun;17(2):115-122. doi: 10.4274/tjod.galenos.2020.12129. Epub 2020 Jul 29.

  PMID: 32850186 BACKGROUND

• Kaya C, Alay I, Yildiz S, Cengiz H, Afandi X, Yasar L. The Feasibility of Natural Orifice Transluminal Endoscopic Surgery in Gynecology Practice: Single-Surgeon Experience. Gynecol Minim Invasive Ther. 2020 Apr 28;9(2):69-73. doi: 10.4103/GMIT.GMIT_84_19. eCollection 2020 Apr-Jun.

  PMID: 32676283 BACKGROUND

• Baekelandt JF, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol BWJ, Bosteels JJA. Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) adnexectomy for benign pathology compared with laparoscopic excision (NOTABLE): a protocol for a randomised controlled trial. BMJ Open. 2018 Jan 10;8(1):e018059. doi: 10.1136/bmjopen-2017-018059.

  PMID: 29326183 BACKGROUND

• Yassa M, Kaya C, Kalafat E, Tekin AB, Karakas S, Mutlu MA, Birol P, Tug N. The Comparison of Transvaginal Natural Orifice Transluminal Endoscopic Surgery and Conventional Laparoscopy in Opportunistic Bilateral Salpingectomy for Permanent Female Sterilization. J Minim Invasive Gynecol. 2022 Feb;29(2):257-264.e1. doi: 10.1016/j.jmig.2021.08.009. Epub 2021 Aug 16.

  PMID: 34411729 DERIVED

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Cihan Kaya, MD

  Bakirkoy Sadi Konuk Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 22, 2021
• Study Start: February 12, 2021
• Primary Completion: May 9, 2021
• Study Completion: May 9, 2021
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Upon request, after the work is published, 5 years
• Access Criteria: Upon request, after the work is published, 5 years

Locations

TU (2)