Clinical trial NCT06776718: VNOTES and Vaginal Hysterectomy for Benign Indications
Official title: Comparison of VNOTES and Vaginal Hysterectomy for Benign Indications
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hysterectomy
Hysterectomy, Benign Uterine Diseases
Hysterectomy, Vaginal
Keywords: vNOTES
vaginal hysterectomy
benign gynecology
surgical outcomes
Pain
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-01-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aimed to compare the surgical outcomes of Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) and conventional vaginal hysterectomy (VH) for benign gynecological conditions.

A prospective analysis will conducted at a tertiary hospital from January 2025 to February 2025. Patients aged 40-80 who underwent hysterectomy for benign indications will included. Outcomes will assessed included surgical outcomes, Visual Analog Scale (VAS) pain scores, and complication rates.


Eligibility criteria: Inclusion Criteria:

* aged between 40 and 80 years
* undergo hysterectomy for benign gynecological conditions

Exclusion Criteria:

* history of urogynecological surgery (including pelvic organ prolapse surgery and mid-urethral sling procedures),
* suspected gynecologic malignancies,
* endometriosis,
* tubal-ovarian abscesses,
* pelvic organ prolapse exceeding grade 2,
* individuals who refused to participate in the study

Primary outcomes:
measure: the duration of surgery
timeFrame: The time from the beginning to the end of the operation
Secondary outcomes:
measure: Hospitalization time
timeFrame: through study completion, an average of 1 month
measure: VAS score
timeFrame: postoperative 6th and 24 th hour
measure: Uterin volume
timeFrame: through study completion, an average of 1 month
measure: Re-admission
timeFrame: within 1 month after discharge
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kartal Dr Lütfi Kirdar City Hospital
Study officials:
References:
citation: Yildiz P, Keles E, Yildiz G, Birol Ilter P, Temocin RB, Kaya C, Mat E. Health-related quality of life following hysterectomy by vNOTES versus conventional laparoscopy. Minim Invasive Ther Allied Technol. 2024 Aug;33(4):232-236. doi: 10.1080/13645706.2024.2323100. Epub 2024 Mar 4.
citation: Merlier M, Collinet P, Pierache A, Vandendriessche D, Delporte V, Rubod C, Cosson M, Giraudet G. Is V-NOTES Hysterectomy as Safe and Feasible as Outpatient Surgery Compared with Vaginal Hysterectomy? J Minim Invasive Gynecol. 2022 May;29(5):665-672. doi: 10.1016/j.jmig.2022.01.007. Epub 2022 Jan 21.
citation: Baekelandt JF, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol B, Bosteels J. Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial. BJOG. 2019 Jan;126(1):105-113. doi: 10.1111/1471-0528.15504.
citation: Pickett CM, Seeratan DD, Mol BWJ, Nieboer TE, Johnson N, Bonestroo T, Aarts JW. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2023 Aug 29;8(8):CD003677. doi: 10.1002/14651858.CD003677.pub6.