vNOTES in Elective Bilateral Salpingectomy for Sterilization

• ClinicalTrials.gov Identifier: NCT04809428
• Recruitment Status: Completed
• First Posted: March 22, 2021
• Last Update Posted: June 11, 2021
• Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
• Collaborator: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Information provided by (Responsible Party): Murat Yassa, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Study Description

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

Condition or disease	Intervention/treatment
Sterility, Female	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 Design

• Study Type: Observational
• Actual Enrollment: 98 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Use of vNOTES Approach in Elective Bilateral Salpingectomy for Sterilization as a Cancer Prevention Strategy
• Actual Study Start Date: February 12, 2021
• Actual Primary Completion Date: May 9, 2021
• Actual Study Completion Date: May 9, 2021

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Patient satisfaction at first week [ Time Frame: The first week after the surgical procedure ]
   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.
2. Patient satisfaction at first month [ Time Frame: The first month after the surgical procedure ]
   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.
3. Postoperative pain at 6th hours [ Time Frame: At the 6th hours after the surgical procedure ]
   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.
4. Postoperative pain at 24th hours [ Time Frame: At the 24th hours after the surgical procedure ]
   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.

Secondary Outcome Measures :

1. Dyspareunia [ Time Frame: At 1st month after the surgical procedure ]

   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.

2. Duration of the surgical procedure [ Time Frame: Intraoperative ]
   Duration of the surgery will be measured in minutes, in between the first vaginal/abdominal incision and vaginal/abdominal wound closure.
3. Conversion [ Time Frame: Intraoperative ]
   Conversion to laparoscopy or laparotomy will be noted.
4. Need of Analgesics [ Time Frame: Postoperative, 24 hours ]
   Patients will not be routinely offered additional analgesics and the need of additional analgesics will be noted if patient desires for.
5. Intraoperative complications [ Time Frame: Intraoperative ]
   Any minor and major (e.g., bowel injury, bleeding>300cc, major vessel injury) complications that occur during the surgery
6. Postoperative complications [ Time Frame: Postoperative, in the first month of the surgery ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• 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.

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

Contacts and Locations

Locations

Turkey

Bakirkoy Sadi Konuk Training and Research Hospital

Istanbul, Turkey

Sehit Prof Dr Ilhan Varank Training and Research Hospital

Istanbul, Turkey

Sponsors and Collaborators

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

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

• Principal Investigator: Cihan Kaya, MD; Bakirkoy Sadi Konuk Training and Research Hospital

More Information

Publications:

Kaya C, Alay I, Cengiz H, Baghaki S, Aslan O, Ekin M, Yaşar 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, Pulatoğlu Ç. 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.

• Responsible Party: Murat Yassa, Principal investigator, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT04809428
• Other Study ID Numbers: vNOTES Salpingectomy
• First Posted: March 22, 2021
• Last Update Posted: June 11, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Upon request, after the work is published
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: Upon request, after the work is published, 5 years
• Access Criteria: Upon request, after the work is published, 5 years

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Murat Yassa, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital:

vNOTES; Scarless surgery; cancer prevention

Additional relevant MeSH terms:

Infertility; Infertility, Female