Clinical trial NCT04809428: vNOTES in Elective Bilateral Salpingectomy for Sterilization
Official title: The Use of vNOTES Approach in Elective Bilateral Salpingectomy for Sterilization as a Cancer Prevention Strategy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sterility, Female
Keywords: vNOTES
Scarless surgery
cancer prevention
Lead sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
First posted: 2021-03-22
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient satisfaction at first week
timeFrame: The first week after the surgical procedure
measure: Patient satisfaction at first month
timeFrame: The first month after the surgical procedure
measure: Postoperative pain at 6th hours
timeFrame: At the 6th hours after the surgical procedure
measure: Postoperative pain at 24th hours
timeFrame: At the 24th hours after the surgical procedure
Secondary outcomes:
measure: Dyspareunia
timeFrame: At 1st month after the surgical procedure
measure: Duration of the surgical procedure
timeFrame: Intraoperative
measure: Conversion
timeFrame: Intraoperative
measure: Need of Analgesics
timeFrame: Postoperative, 24 hours
measure: Intraoperative complications
timeFrame: Intraoperative
measure: Postoperative complications
timeFrame: Postoperative, in the first month of the surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Sadi Konuk Training and Research Hospital
city: Istanbul
country: Turkey
facility: Sehit Prof Dr Ilhan Varank Training and Research Hospital
Study officials:
affiliation: Bakirkoy Sadi Konuk Training and Research Hospital
name: Cihan Kaya, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.