vNOTES in Elective Bilateral Salpingectomy for Sterilization

The Use of vNOTES Approach in Elective Bilateral Salpingectomy for Sterilization as a Cancer Prevention Strategy

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

Study Overview

• Status: Completed
• Conditions: Sterility, Female
• Intervention / Treatment: Procedure: vNOTES salpingectomy; Procedure: Laparoscopic salpingectomy

Detailed Description

Women who are indicated or seek for surgical sterilisation are routinely offered salpingectomy rather than tubal ligation for cancer prevention purposes as a local protocol. Those patients will be offered for vNOTES approach after detailed patient counselling and will be enrolled to the study upon acceptation.

• Study Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bakirkoy Sadi Konuk Training and Research Hospital
  • Istanbul, Turkey
    • Sehit Prof Dr Ilhan Varank Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
vNOTES Salpingectomy; Elective bilateral salpingectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery approach	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.
LS Salpingectomy; Elective bilateral salpingectomy by conventional laparoscopy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspareunia	Subjective Success - Change from baseline Female Sexual Function Index (FSFI) to measure sexual dysfunction at first month. Validated into Turkish language form will be used to compare preoperative and postoperative period. The FSFI is a multiple-trait scoring, self-report document used to assess female sexual function. It consists of 19 items that encompass six separate domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The maximum score is 36 points and the minimum score is 2 points. Only pain subdomain will be used for research purposes.	At 1st month after the surgical procedure
Duration of the surgical procedure	Duration of the surgery will be measured in minutes, in between the first vaginal/abdominal incision and vaginal/abdominal wound closure.	Intraoperative
Conversion	Conversion to laparoscopy or laparotomy will be noted.	Intraoperative
Need of Analgesics	Patients will not be routinely offered additional analgesics and the need of additional analgesics will be noted if patient desires for.	Postoperative, 24 hours
Intraoperative complications	Any minor and major (e.g., bowel injury, bleeding>300cc, major vessel injury) complications that occur during the surgery	Intraoperative
Postoperative complications	Any minor and major complications (e.g., bowel injury, haematoma, infection, dyspareunia, vaginal pain, sexual discomfort) that occur in the first month of the surgery.	Postoperative, in the first month of the surgery

Collaborators and Investigators

• Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
• Collaborators: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Investigators: Principal Investigator: Cihan Kaya, MD, Bakirkoy Sadi Konuk Training and Research Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: J Minim Invasive Gynecol. 2022 May;29(5):691.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 12, 2021
• Primary Completion (ACTUAL): May 9, 2021
• Study Completion (ACTUAL): May 9, 2021

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (ACTUAL): March 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: vNOTES; cancer prevention; Scarless surgery
• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: vNOTES Salpingectomy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon request, after the work is published
• IPD Sharing Time Frame: Upon request, after the work is published, 5 years
• IPD Sharing Access Criteria: Upon request, after the work is published, 5 years
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No