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| Name | Class |
|---|---|
| Bakirkoy Dr. Sadi Konuk Research and Training Hospital | OTHER_GOV |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vNOTES Salpingectomy | Elective bilateral salpingectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery approach |
| |
| LS Salpingectomy | Elective bilateral salpingectomy by conventional laparoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Women seeking for definitive surgical sterilization who prefers salpingectomy over tubal ligation due to its possible cancer risk reduction effect.
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| Name | Affiliation | Role |
|---|---|---|
| Cihan Kaya, MD | Bakirkoy Sadi Konuk Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bakirkoy Sadi Konuk Training and Research Hospital | Istanbul | Turkey (Türkiye) | ||||
| Sehit Prof Dr Ilhan Varank Training and Research Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32633168 | Background | 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. | |
| 32850186 | Background |
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Upon request, after the work is published
Upon request, after the work is published, 5 years
Upon request, after the work is published, 5 years
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 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. |
|
| At 1st month after the surgical procedure |
| 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 |
| Conversion | Conversion to laparoscopy or laparotomy will be noted. | Intraoperative |
| 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 |
| Intraoperative complications | Any minor and major (e.g., bowel injury, bleeding>300cc, major vessel injury) complications that occur during the surgery | Intraoperative |
| 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 |
| Istanbul |
| Turkey (Türkiye) |
| 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. |
| 32676283 | Background | 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. |
| 29326183 | Background | 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. |
| 34411729 | Derived | 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. |
| D000091662 | Genital Diseases |
| D007246 | Infertility |