VNOTES and Vaginal Hysterectomy for Benign Indications
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: vNOTES, vaginal hysterectomy.
- Who it may be relevant to
- Registry conditions: Hysterectomy, Hysterectomy, Benign Uterine Diseases, Hysterectomy, Vaginal. Basic parameters: 40 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of VNOTES and Vaginal Hysterectomy for Benign Indications
Overview
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.
Interventions
- Procedure vNOTES
vNOTES for benign hysterectomy - Procedure vaginal hysterectomy
vaginal hysterectomy for benign hysterectomy
Primary outcome measures
- the duration of surgery [Time frame: The time from the beginning to the end of the operation]
Secondary outcome measures (4)
- Hospitalization time [Time frame: through study completion, an average of 1 month]
- VAS score [Time frame: postoperative 6th and 24 th hour]
- Uterin volume [Time frame: through study completion, an average of 1 month]
- Re-admission [Time frame: within 1 month after discharge]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Turkey (Türkiye) · 1 center
- Kartal Dr Lütfi Kirdar City Hospital — Istanbul
Publications
- 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. PMID 39084252
- 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. PMID 35074513
- 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. PMID 30325565
- 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. PMID 37642285
Identifiers
NCT: NCT06776718 · 2021/514/214/25