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NCT Number: NCT04809428

vNOTES in Elective Bilateral Salpingectomy for Sterilization

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

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Bakirkoy Sadi Konuk Training and Research Hospital, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2021
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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