Endometrial AdenocarcinomaV-COSMOSNCT07583329
Comparison of Sentinel Lymph Node Applications in Endometrial Cancer Cases Performed With Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) and Conventional Laparoscopy
An observational study of Endometrial Adenocarcinoma and Endometrial Cancer, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Endometrial cancer is a common cancer in women, and surgery is usually the first step in treatment. During surgery, doctors often check nearby lymph nodes to see if the cancer has spread. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Adenocarcinoma, Endometrial Cancer
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 May 2026to 30 Apr 2036
- How long will I take part?
- 10 Years
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Histologically confirmed endometrial cancer on preoperative endometrial biopsy
Who may be able to join
- Age ≥18 years
- Histologically confirmed endometrial cancer on preoperative endometrial biopsy
- Disease confirmed to be confined to the uterus based on clinical evaluation and imaging
- No evidence of lymphatic or distant metastasis on positron emission tomography/computed tomography(PET/CT) or magnetic resonance imaging (MRI)
- Surgical staging with sentinel lymph node biopsy recommended by a multidisciplinary tumor board
- Surgical treatment performed using either conventional laparoscopy or the vNOTES approach
Who cannot join
- Presence of extrauterine disease
- Detection of distant metastasis
- Surgery performed via an open (laparotomy) approach
- Incomplete medical records
- History of prior pelvic radiotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Sentinel Lymph Node Applications in Endometrial Cancer Cases Performed With V-NOTES and Conventional Laparoscopy: A Multicenter Prospective Observational Study
Endometrial cancer is a common cancer in women, and surgery is usually the first step in treatment. During surgery, doctors often check nearby lymph nodes to see if the cancer has spread. A newer method called sentinel lymph node (SLN) mapping allows doctors to examine only the first few lymph nodes most likely to contain cancer. This can reduce the need for removing many lymph nodes and may lower the risk of complications.
Minimally invasive surgery is commonly performed using small abdominal incisions (laparoscopy). A newer technique, called vaginal natural orifice transluminal endoscopic surgery (vNOTES), allows the surgery to be performed through the vagina without any cuts on the abdomen. This approach may lead to less pain, quicker recovery, and no visible scars.
Read more
This study will compare these two surgical methods-laparoscopy and vNOTES-in patients with early-stage endometrial cancer. Researchers will look at how safe and effective each method is, how patients recover after surgery, and how well the sentinel lymph node procedure works with each technique. The study will also examine how quickly surgeons become experienced with the newer vNOTES method.
The goal of this research is to determine whether vNOTES can be a safe and effective alternative to standard laparoscopic surgery, while offering potential benefits for patients.
Read the detailed description
Endometrial cancer is one of the most common malignancies of the female genital tract, and surgical staging constitutes the cornerstone of its management. In recent years, sentinel lymph node (SLN) mapping has been increasingly used as an alternative to systematic pelvic and paraaortic lymphadenectomy. The SLN approach reduces unnecessary extensive lymph node dissections, thereby decreasing surgical morbidity while enabling reliable assessment of lymphatic spread.
With the advancement of minimally invasive surgery, conventional laparoscopy has become widely used in the surgical management of endometrial cancer. In recent years, however, transvaginal natural orifice transluminal endoscopic surgery (vNOTES) has been increasingly adopted in gynecologic surgery due to its potential advantages, including the absence of abdominal incisions, reduced postoperative pain, faster recovery, and improved cosmetic outcomes. Nevertheless, prospective data comparing the vNOTES approach with conventional laparoscopy-particularly in terms of SLN mapping success and surgical outcomes-remain limited.
The aim of this study is to comparatively evaluate the feasibility, efficacy, safety, perioperative outcomes, and impact on survival of retroperitoneal sentinel lymph node biopsy (SLNB) performed using two different minimally invasive surgical approaches-standard conventional laparoscopy and vNOTES-in patients diagnosed with endometrial cancer that is clinically and radiologically presumed to be confined to the uterus. Another objective is to assess the learning curve of surgeons for the relatively new vNOTES technique in relation to the number of cases performed.
The primary hypothesis of the study is that SLNB performed via the vNOTES approach is a safe, effective, and feasible minimally invasive surgical alternative compared to conventional laparoscopy.
- Conditions
- Endometrial Adenocarcinoma, Endometrial Cancer
- Keywords
- v-notes, sentinel lymph node, conventional laparoscopy
- Medical subject headings
- Endometrial Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Sentinel Lymph Node Detection Rates in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy
Measured: Baseline (pre-procedure), perioperative/periprocedural period
Secondary outcomes (4)
The Relationship Between Case Volume and the Learning Curve of Surgeons for Sentinel Lymph Node Procedures in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy
Measured: Baseline (pre-procedure), perioperative/periprocedural period
The Impact of Sentinel Lymph Node Applications on Progression-Free Survival in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy
The impact of sentinel lymph node applications on progression-free survival in endometrial cancer cases performed with V-NOTES and conventional laparoscopy will be evaluated over a follow-up period of 5 years. Progression-free survival is defined as the time from surgery to the first documented disease recurrence, progression, or death from any cause.
Measured: up to 5 years
The Impact of Sentinel Lymph Node Applications on Overall Survival in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy
The impact of sentinel lymph node applications on overall survival in endometrial cancer cases performed with V-NOTES and conventional laparoscopy will be evaluated over a follow-up period of 10 years. Overall survival is defined as the time from surgery to death from any cause.
Measured: Up to 10 years
Evaluation of Surgical Complications in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy
Measured: Baseline (pre-procedure), 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 posted13 May 2026
- Study start19 May 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2036 (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 Endometrial AdenocarcinomaStudies 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
- 160 participants (estimated)
- Target duration
- 10 Years
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
- NCT07583329
- Sponsor's protocol ID
- 164/61
- Acronym
- V-COSMOS
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Odgers H, Lin A, Tejada-Berges T. Comparison of laparoscopic vs. robotic sentinel lymph node mapping and biopsy in endometrial cancer. J Robot Surg. 2025 Apr 24;19(1):173. doi: 10.1007/s11701-025-02300-w.
PubMed 40272600Baekelandt J, Jespers A, Huber D, Badiglian-Filho L, Stuart A, Chuang L, Ali O, Burnett A. vNOTES retroperitoneal sentinel lymph node dissection for endometrial cancer staging: First multicenter, prospective case series. Acta Obstet Gynecol Scand. 2024 Jul;103(7):1311-1317. doi: 10.1111/aogs.14843. Epub 2024 Apr 16.
PubMed 38623778Nadaban M, Balint O, Secosan C, Furau AM, Olaru F, Pirtea L. V-Notes Sentinel Lymph Node Staging for Endometrial Cancer: A Systematic Review. J Clin Med. 2025 Sep 12;14(18):6451. doi: 10.3390/jcm14186451.
PubMed 41010655
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sentinel Lymph Node Applications in Endometrial Cancer Cases Performed With V-NOTES and Conventional Laparoscopy: A Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07583329
- Acronym / sponsor ID
- V-COSMOS / 164/61
- Conditions
- Endometrial Adenocarcinoma, Endometrial Cancer
- Keywords
- v-notes, sentinel lymph node, conventional laparoscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 19 May 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2036 (estimated)
- First posted
- 13 May 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.
Endometrial cancer is a common cancer in women, and surgery is usually the first step in treatment. During surgery, doctors often check nearby lymph nodes to see if the cancer has spread. A newer method called sentinel lymph node (SLN) mapping allows doctors to examine only the first few lymph nodes most likely to contain cancer. This can reduce the need for removing many lymph nodes and may lower the risk of complications.
Minimally invasive surgery is commonly performed using small abdominal incisions (laparoscopy). A newer technique, called vaginal natural orifice transluminal endoscopic surgery (vNOTES), allows the surgery to be performed through the vagina without any cuts on the abdomen. This approach may lead to less pain, quicker recovery, and no visible scars.
This study will compare these two surgical methods-laparoscopy and vNOTES-in patients with early-stage endometrial cancer. Researchers will look at how safe and effective each method is, how patients recover after surgery, and how well the sentinel lymph node procedure works with each technique. The study will also examine how quickly surgeons become experienced with the newer vNOTES method.
The goal of this research is to determine whether vNOTES can be a safe and effective alternative to standard laparoscopic surgery, while offering potential benefits for patients.
Detailed description
Endometrial cancer is one of the most common malignancies of the female genital tract, and surgical staging constitutes the cornerstone of its management. In recent years, sentinel lymph node (SLN) mapping has been increasingly used as an alternative to systematic pelvic and paraaortic lymphadenectomy. The SLN approach reduces unnecessary extensive lymph node dissections, thereby decreasing surgical morbidity while enabling reliable assessment of lymphatic spread.
With the advancement of minimally invasive surgery, conventional laparoscopy has become widely used in the surgical management of endometrial cancer. In recent years, however, transvaginal natural orifice transluminal endoscopic surgery (vNOTES) has been increasingly adopted in gynecologic surgery due to its potential advantages, including the absence of abdominal incisions, reduced postoperative pain, faster recovery, and improved cosmetic outcomes. Nevertheless, prospective data comparing the vNOTES approach with conventional laparoscopy-particularly in terms of SLN mapping success and surgical outcomes-remain limited.
The aim of this study is to comparatively evaluate the feasibility, efficacy, safety, perioperative outcomes, and impact on survival of retroperitoneal sentinel lymph node biopsy (SLNB) performed using two different minimally invasive surgical approaches-standard conventional laparoscopy and vNOTES-in patients diagnosed with endometrial cancer that is clinically and radiologically presumed to be confined to the uterus. Another objective is to assess the learning curve of surgeons for the relatively new vNOTES technique in relation to the number of cases performed.
The primary hypothesis of the study is that SLNB performed via the vNOTES approach is a safe, effective, and feasible minimally invasive surgical alternative compared to conventional laparoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically confirmed endometrial cancer on preoperative endometrial biopsy
Key inclusion criteria (6 listed)
- Age ≥18 years
- Histologically confirmed endometrial cancer on preoperative endometrial biopsy
- Disease confirmed to be confined to the uterus based on clinical evaluation and imaging
- No evidence of lymphatic or distant metastasis on positron emission tomography/computed tomography(PET/CT) or magnetic resonance imaging (MRI)
- Surgical staging with sentinel lymph node biopsy recommended by a multidisciplinary tumor board
Key exclusion criteria (5 listed)
- Presence of extrauterine disease
- Detection of distant metastasis
- Surgery performed via an open (laparotomy) approach
- Incomplete medical records
- History of prior pelvic radiotherapy
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
Evaluation of Sentinel Lymph Node Detection Rates in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy
Time frame: Baseline (pre-procedure), perioperative/periprocedural period
4 secondary outcomes
The Relationship Between Case Volume and the Learning Curve of Surgeons for Sentinel Lymph Node Procedures in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy
Time frame: Baseline (pre-procedure), perioperative/periprocedural period
The Impact of Sentinel Lymph Node Applications on Progression-Free Survival in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy
Time frame: up to 5 years
The Impact of Sentinel Lymph Node Applications on Overall Survival in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy
Time frame: Up to 10 years
Evaluation of Surgical Complications in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy
Time frame: Baseline (pre-procedure), 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 20 May 2026.
- Background: PubMed 40272600Odgers H, Lin A, Tejada-Berges T. Comparison of laparoscopic vs. robotic sentinel lymph node mapping and biopsy in endometrial cancer. J Robot Surg. 2025 Apr 24;19(1):173. doi: 10.1007/s11701-025-02300-w.
- Background: PubMed 38623778Baekelandt J, Jespers A, Huber D, Badiglian-Filho L, Stuart A, Chuang L, Ali O, Burnett A. vNOTES retroperitoneal sentinel lymph node dissection for endometrial cancer staging: First multicenter, prospective case series. Acta Obstet Gynecol Scand. 2024 Jul;103(7):1311-1317. doi: 10.1111/aogs.14843. Epub 2024 Apr 16.
- Background: PubMed 41010655Nadaban M, Balint O, Secosan C, Furau AM, Olaru F, Pirtea L. V-Notes Sentinel Lymph Node Staging for Endometrial Cancer: A Systematic Review. J Clin Med. 2025 Sep 12;14(18):6451. doi: 10.3390/jcm14186451.
- 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.
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 Endometrial Adenocarcinoma and Endometrial Cancer, 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 20 May 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?
Contact Ghanim Khatib (+903223386060, ghanim.khatib@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Sentinel Lymph Node Detection Rates in Endometrial Cancer Cases Performed with V-NOTES and Conventional Laparoscopy (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 NCT07583329, 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 20 May 2026.