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NCT Number: NCT07465822

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Acronym: LC of V-NOTES

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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