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Sterility, FemaleNCT04809428

vNOTES in Elective Bilateral Salpingectomy for Sterilization

An observational study of Sterility, Female, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Sterility, Female
What is being tested?
vNOTES salpingectomy and Laparoscopic salpingectomy
Type of treatment
Surgery or procedure
How many people
98 participants
Where
2 sitesTurkey (Türkiye)
Study dates
12 Feb 2021to 9 May 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Bakirkoy Sadi Konuk Training and Research Hospital

    Istanbul

  • Sehit Prof Dr Ilhan Varank Training and Research Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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

Read the 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.

Being tested
vNOTES salpingectomy, Laparoscopic salpingectomy
Keywords
vNOTES, Scarless surgery, cancer prevention
Medical subject headings
Infertility, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vNOTES salpingectomyProcedure or surgery

    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.

  • Laparoscopic salpingectomyProcedure or surgery

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

Study groups in NCT04809428
Study groupRoleWhat they receive
vNOTES SalpingectomyElective bilateral salpingectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery approach
Receives: Procedure: vNOTES salpingectomy
LS SalpingectomyElective bilateral salpingectomy by conventional laparoscopy
Receives: Procedure: Laparoscopic salpingectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: The first week after the surgical procedure

  2. 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.

    Measured: The first month after the surgical procedure

  3. 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.

    Measured: At the 6th hours after the surgical procedure

  4. 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.

    Measured: At the 24th hours after the surgical procedure

Secondary outcomes (6)

  1. 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.

    Measured: At 1st month after the surgical procedure

  2. 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.

    Measured: Intraoperative

  3. Conversion

    Conversion to laparoscopy or laparotomy will be noted.

    Measured: Intraoperative

  4. Need of Analgesics

    Patients will not be routinely offered additional analgesics and the need of additional analgesics will be noted if patient desires for.

    Measured: Postoperative, 24 hours

  5. Intraoperative complications

    Any minor and major (e.g., bowel injury, bleeding>300cc, major vessel injury) complications that occur during the surgery

    Measured: Intraoperative

  6. 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.

    Measured: Postoperative, in the first month of the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2021
  2. Study start12 Feb 2021
  3. Primary completion9 May 2021
  4. Study completion9 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04809428
Sponsor's protocol ID
vNOTES Salpingectomy
Status last verified
Jun 2021
First submitted
16 Mar 2021
Last updated
11 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Upon request, after the work is published

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.

    PubMed 32633168

  • 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.

    PubMed 32850186

  • 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.

    PubMed 32676283

  • 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.

    PubMed 29326183

  • 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.

    PubMed 34411729

Questions about this trial

What is this clinical trial studying?

An observational study of Sterility, Female, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient satisfaction at first week (time frame: The first week after the surgical procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04809428, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.

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