NCT07465822

Brief Summary

This prospective observational study aims to evaluate the learning curve of obstetrics and gynecology residents performing Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) hysterectomy in a university hospital setting. V-NOTES hysterectomy is a minimally invasive surgical technique performed through the vaginal route that combines the advantages of laparoscopy without requiring abdominal incisions. The study will assess the progression of surgical performance of a resident performing V-NOTES hysterectomy under the supervision of an experienced attending surgeon. Key operative and postoperative outcomes will be recorded to evaluate the acquisition of surgical proficiency over time.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Apr 2025Oct 2026

Study Start

First participant enrolled

April 18, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.5 years

First QC Date

March 3, 2026

Last Update Submit

March 17, 2026

Conditions

Keywords

learning curvehysterectomyvaginal natural orifisresident doctorminimally invasive

Outcome Measures

Primary Outcomes (1)

  • Operative time of V-NOTES hysterectomy

    Operative time will be defined as the time interval between the initial vaginal incision and completion of vaginal cuff closure.

    Baseline (pre-procedure), perioperative/periprocedural period

Secondary Outcomes (1)

  • Intraoperative complications

    perioperative/periprocedural period

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients deemed suitable for V-NOTES hysterectomy based on preoperative evaluation

You may qualify if:

  • Voluntary participation in the study and provision of written informed consent
  • Female patients aged between 18 and 70 years
  • Patients admitted to the Department of Obstetrics and Gynecology at Çukurova -University and scheduled for elective hysterectomy
  • Patients deemed suitable for V-NOTES hysterectomy based on preoperative evaluation

You may not qualify if:

  • Refusal to provide informed consent
  • Anatomical or technical limitations preventing placement in the lithotomy -position
  • Pregnancy
  • Presence of acute abdomen or indication for emergency surgery
  • Presence or history of deep infiltrating endometriosis
  • Suspected pelvic adhesions
  • Detection of a nodule in the pouch of Douglas
  • Fixed uterus on pelvic examination
  • Sexually inactive patients
  • History of tubo-ovarian abscess

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, 01000, Turkey (Türkiye)

Location

Related Publications (3)

  • Pickett CM,Seeratan DD,Mol BWJ,Nieboer TE,Johnson N,Bonestroo T,Aarts JW

    BACKGROUND
  • Wang CJ,Go J,Huang HY,Wu KY,Huang YT,Liu YC,Weng CH

    BACKGROUND
  • Aarts JW,Nieboer TE,Johnson N,Tavender E,Garry R,Mol BW,Kluivers KB

    BACKGROUND

MeSH Terms

Conditions

MetrorrhagiaAdenomyosisMyofibroma

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 12, 2026

Study Start

April 18, 2025

Primary Completion (Estimated)

October 3, 2026

Study Completion (Estimated)

October 4, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations