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临床试验/NCT07465822
NCT07465822进行中(未招募)不适用

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

Cukurova University1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2025年4月18日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
19
试验地点
1
主要终点
Operative time of V-NOTES hysterectomy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Operative time of V-NOTES hysterectomy

时间窗: 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.

次要结局

  • Intraoperative complications(perioperative/periprocedural period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghanim Khatib

Professor

Cukurova University

研究点 (1)

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