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Not yet recruitingNCT06776718Updated Jan 15, 2025

VNOTES and Vaginal Hysterectomy for Benign Indications

An interventional study of vNOTES and vaginal hysterectomy in Hysterectomy, Hysterectomy, Benign Uterine Diseases and Hysterectomy, Vaginal, sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital. Not yet recruiting at 1 site in Turkey. Open to female participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-15.

Sponsored by Dr. Lutfi Kirdar Kartal Training and Research Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Hysterectomy
  • Hysterectomy, Benign Uterine Diseases
  • Hysterectomy, Vaginal

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Keywords

  • vNOTES
  • vaginal hysterectomy
  • benign gynecology
  • surgical outcomes
  • Pain
03

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 100 is above the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital is the lead sponsor of 78 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • history of urogynecological surgery (including pelvic organ prolapse surgery and mid-urethral sling procedures),
  • suspected gynecologic ,
  • endometriosis,
  • tubal-ovarian abscesses,
  • pelvic organ prolapse exceeding grade 2,
  • individuals who refused to participate in the study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    vNOTES hysterectomy for benign indications

    Procedure: vNOTES

  • Experimental
    Vaginal hysterectomy for benign indications

    Procedure: vaginal hysterectomy

Interventions

  • ProcedurevNOTES

    vNOTES for benign hysterectomy

  • Procedurevaginal hysterectomy

    vaginal hysterectomy for benign hysterectomy

06

What researchers measure

Primary outcomes

  1. the duration of surgery

    İnterval from initial incision to the completion of vaginal cuff closure (minute)

    Time frame: The time from the beginning to the end of the operation

Secondary outcomes

  1. Hospitalization time

    Time from surgery to discharge (hours)

    Time frame: through study completion, an average of 1 month

  2. VAS score

    Visual Analog Score for pain at postoperative 6th and 24 th hour (0-10)

    Time frame: postoperative 6th and 24 th hour

  3. Uterin volume

    Uterine volume is quantified in milimeters based on measurement of pathological specimens, calculate using the formula (Uterine volume (ml)= (anterior-posterior diameter)\* (sagital diameter) \* (transverse diameter) \* 0,0005236

    Time frame: through study completion, an average of 1 month

  4. Re-admission

    Re-admission to hospital after discharge (yes/no)

    Time frame: within 1 month after discharge

07

Study locations

1 site
  • Kartal Dr Lütfi Kirdar City Hospital
    İstanbul, 34865, Turkey
    • Kartal Dr. Lütfi Kırdar Şehir Hastanesi · Contactistkartal.sh@saglik.gov.tr · +902164413900
    • Gazi Yıldız, Assoc Prof · Contact
    • Pınar Yıldız, MD · Contact
    • Esra Keleş, Assoc Prof · Contact
    • Pınar Birol İlter, MD · Contact
    • Kasım Turan, MD · Contact
    • Emre Mat, Assoc Prof · Contact
    • Mehmet Mete Kırlangıç, Assoc Prof · Contact
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 37642285 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2025; primary completion for Feb 2025, 1 month later.

Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 1 month is below that.

Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 24, 2024
First posted
Jan 15, 2025
StartEst.
Jan 2025
Primary completionEst.
Feb 2025
CompletionEst.
Feb 2025
Last update
Jan 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06776718
Lead sponsor
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Responsible party
Mehmet Mete Kırlangıç (Assoc Prof, Dr. Lutfi Kirdar Kartal Training and Research Hospital) — Principal investigator
First posted
Jan 15, 2025
Start date
Jan 2025 (estimated)
Primary completion
Feb 2025 (estimated)
Completion
Feb 2025 (estimated)
Last update
Jan 15, 2025

Study contacts

Gazi Yıldız, Assoc Prof
Contact
drgaziyildiz@gmail.com
+905535288666
Mehmet Mete Kırlangıç, Assoc Prof
Contact
metekirlangic@gmail.com
+905064641819

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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