The Learning Curve of a Gynecology and Obstetrics Resident Performing Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) Hysterectomy in a University Hospital (LC of V-NOTES)

March 17, 2026 updated by: Ghanim Khatib, Cukurova University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) hysterectomy represents a novel minimally invasive surgical approach that enables laparoscopic visualization and precise tissue dissection through the vaginal route without abdominal wall incisions. Previous studies have reported several advantages of this technique, including reduced postoperative pain, earlier mobilization, shorter hospital stay, and improved cosmetic outcomes compared with conventional surgical approaches.

With the increasing adoption of minimally invasive surgical techniques in gynecology, structured training models have become essential for safe and effective implementation during residency education. However, the learning process for newly introduced surgical techniques such as V-NOTES remains insufficiently characterized, particularly regarding the time required for residents to achieve procedural proficiency.

This prospective observational study aims to investigate the learning curve of an obstetrics and gynecology resident performing V-NOTES hysterectomy in a university hospital environment under the supervision of an experienced attending surgeon. Consecutive patients undergoing elective hysterectomy who are deemed suitable for V-NOTES will be included in the study after providing informed consent.

For each surgical procedure, objective parameters including operative time, estimated intraoperative blood loss, intraoperative complications, postoperative pain scores, postoperative analgesic requirements, and length of hospital stay will be recorded. Changes in these parameters over sequential cases will be analyzed to determine the progression of surgical performance and to define the learning curve associated with V-NOTES hysterectomy.

The findings of this study are expected to contribute to the optimization of institutional surgical training models and to provide additional data to the national and international literature regarding the safety, feasibility, and teachability of V-NOTES surgery. Furthermore, the results may support the development of structured educational strategies aimed at facilitating surgical competency acquisition among residents and promoting the safe dissemination of emerging minimally invasive surgical techniques.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Operative time of V-NOTES hysterectomy
Time Frame: Baseline (pre-procedure), perioperative/periprocedural period
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intraoperative complications
Time Frame: perioperative/periprocedural period
Any complication occurring during surgery including organ injury, hemorrhage requiring additional intervention, or conversion to another surgical technique.
perioperative/periprocedural period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cukurova University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Pickett CM,Seeratan DD,Mol BWJ,Nieboer TE,Johnson N,Bonestroo T,Aarts JW
  • Wang CJ,Go J,Huang HY,Wu KY,Huang YT,Liu YC,Weng CH
  • Aarts JW,Nieboer TE,Johnson N,Tavender E,Garry R,Mol BW,Kluivers KB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 18, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 3, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 4, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 154/37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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