Abnormal Uterine Bleeding, UnspecifiedLC of V-NOTESNCT07465822
The Learning Curve of a Gynecology and Obstetrics Resident Performing Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) Hysterectomy in a University Hospital
An observational study of Abnormal Uterine Bleeding, Unspecified and Benign Gynecological Disease, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Abnormal Uterine Bleeding, Unspecified, Benign Gynecological Disease, Adenomyosis of Uterus
- How many people
- 19 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2025to 4 Oct 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients deemed suitable for V-NOTES hysterectomy based on preoperative evaluation
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Detection of a nodule in the pouch of Douglas
- Fixed uterus on pelvic examination
- Sexually inactive patients
- History of tubo-ovarian abscess
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Abnormal Uterine Bleeding, Unspecified, Benign Gynecological Disease, Adenomyosis of Uterus, Uterine Leiomyomas
- Keywords
- learning curve, hysterectomy, vaginal natural orifis, resident doctor, minimally invasive
- Medical subject headings
- Metrorrhagia, Adenomyosis, Myofibroma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-procedure), perioperative/periprocedural period
Secondary outcomes (1)
Intraoperative complications
Any complication occurring during surgery including organ injury, hemorrhage requiring additional intervention, or conversion to another surgical technique.
Measured: perioperative/periprocedural period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start18 Apr 2025
- Primary completion3 Oct 2026 (estimated)
- Study completion4 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Abnormal Uterine Bleeding, UnspecifiedStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghanim Khatib, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465822
- Sponsor's protocol ID
- 154/37
- Acronym
- LC of V-NOTES
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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 37642285Wang CJ, Go J, Huang HY, Wu KY, Huang YT, Liu YC, Weng CH. Learning curve analysis of transvaginal natural orifice transluminal endoscopic hysterectomy. BMC Surg. 2019 Jul 10;19(1):88. doi: 10.1186/s12893-019-0554-0.
PubMed 31291917Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5.
PubMed 26264829
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Learning Curve of a Gynecology and Obstetrics Resident Performing Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) Hysterectomy in a University Hospital
- ClinicalTrials.gov ID
- NCT07465822
- Acronym / sponsor ID
- LC of V-NOTES / 154/37
- Conditions
- Abnormal Uterine Bleeding, Unspecified, Benign Gynecological Disease, Adenomyosis of Uterus, Uterine Leiomyomas
- Keywords
- learning curve, hysterectomy, vaginal natural orifis, resident doctor, minimally invasive
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- 3 Oct 2026 (estimated)
- Study completion
- 4 Oct 2026 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients deemed suitable for V-NOTES hysterectomy based on preoperative evaluation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Intraoperative complications
Time frame: perioperative/periprocedural period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 37642285Pickett 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.
- Background: PubMed 31291917Wang CJ, Go J, Huang HY, Wu KY, Huang YT, Liu YC, Weng CH. Learning curve analysis of transvaginal natural orifice transluminal endoscopic hysterectomy. BMC Surg. 2019 Jul 10;19(1):88. doi: 10.1186/s12893-019-0554-0.
- Background: PubMed 26264829Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abnormal Uterine Bleeding, Unspecified and Benign Gynecological Disease, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time of V-NOTES hysterectomy (time frame: Baseline (pre-procedure), perioperative/periprocedural period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07465822, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.