vNOTES in Elective Bilateral Salpingectomy for Sterilization

Sterility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04809428
• Other study ID #: vNOTES Salpingectomy
• Status: Completed
• Start date: February 12, 2021
• Est. completion date: May 9, 2021

Study information

• Verified date: June 2021
• Source: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: May 9, 2021
• Est. primary completion date: May 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Sterility, Female

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Bakirkoy Sadi Konuk Training and Research Hospital	Istanbul
Turkey	Sehit Prof Dr Ilhan Varank Training and Research Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital	Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. 2020 Jul 7:1-6. doi: 10.1080/08941939.2020.1789246. [Epub ahead of print] — View 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. — View Citation

Yassa M, Pulatoglu 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Conversion	Conversion to laparoscopy or laparotomy will be noted.	Intraoperative
Secondary	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
Secondary	Intraoperative complications	Any minor and major (e.g., bowel injury, bleeding>300cc, major vessel injury) complications that occur during the surgery	Intraoperative
Secondary	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