Endometrial CancerENDONOTENCT06870903
Comparison of Transvaginal Paracervical and Transperitoneal Approaches in Lymphadenectomy During v-NOTES Surgery for Patients Diagnosed With Endometrial Cancer
A study testing Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomy and Transperitoneal lymphadenectomy in people with Endometrial Cancer and Lymphadenectomy, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare two types of lymphadenectomy (transperitoneal vs. paracervical) during the lymphadenectomy phase of endometrial cancer staging surgery performed using V-NOTES, a new and advanced technique. This study seeks to optimize the V-NOTES technique for endometrial cancer staging. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Endometrial Cancer, Lymphadenectomy, Sentinel Lymph Node Biopsy
- What is being tested?
- Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomy and Transperitoneal lymphadenectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2025to 1 Mar 2026
- Phase
- Interventional
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants whose endometrial biopsy resulted in endometrial cancer and whose disease will be detected limited to the uterus using imaging modalities (computed tomography [CT], magnetic resonance imaging or Fluorine-18 fluorodeoxyglucose positron emission tomography/CT)
- Absence of synchronous malignancies.
- No neoadjuvant treatment before surgical intervention.
Who cannot join
- Contraindications to using methylene blue dye or contraindications to the vNOTES procedure.
- Patients who have had previous malignancy surgery.
- Severe, deeply penetrating endometriosis or enlarged uterus that may require forced vaginal extraction
- Receiving neodajuvant therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi Yasargil Training And Research Hospital
Diyarbakır, Baglar, 21090
kevser.toprak1989@gmail.com
Sedat Akgol
About this study
The aim of this study is to compare two types of lymphadenectomy (transperitoneal vs. paracervical) during the lymphadenectomy phase of endometrial cancer staging surgery performed using V-NOTES, a new and advanced technique. This study seeks to optimize the V-NOTES technique for endometrial cancer staging. This randomized, prospective, controlled study will include patients diagnosed with endometrial cancer via histology, following physical examination and imaging, and who are electively scheduled for the V-NOTES endometrial cancer staging procedure. Patients will be randomized into two groups: the transvaginal paracervical lymphadenectomy group and the transperitoneal lymphadenectomy group. The parameters related with surgical and functional outcomes will be compared in both groups.
Read the detailed description
Surgical staging is often the primary management strategy for endometrial cancer. Sentinel lymph node (SLN) procedures are considered an alternative standard of care in the treatment of significant uterus-confined malignancy. Both accurately estimate nodal status and reduce the surgical morbidity associated with complete lymphadenectomy. Laparoscopic surgery for endometrial cancer has been associated with equal or better quality of life, less blood loss and similar cancer-related outcomes. A new innovation, natural orifice transluminal endoscopic surgery (NOTES), has been developed to further reduce morbidity and scarring associated with laparoscopic surgery. NOTES utilizes the natural orifices of the human body for access to the peritoneal cavity when performing endoscopic surgery.
However, there is no standardization in vNOTES SLN mapping and lymph tracers are diverse. Many procedures and tracers have been reported, such as intra- or retroperitoneal surgery, a range of vaginal surgeries, SLN exposure method, and indocyanine green or methylene blue injection, and they lack comparative studies. This study will evaluate feasibility and surgical outcomes by comparing transvaginal paracervical and transperitoneal mapping in vNOTES hysterectomy with SLN procedure in endometrial cancer.
The study is an observational study with a prospective design. It will be implemented in a single institution, specifically Diyarbakır Gazi Yaşargil Training and Research Hospital, which functions as a tertiary cancer treatment facility.
Between March 2025 and December 2025, patients with newly diagnosed clinical early stage (FIGO 2023 stages 1 and 2) endometrial cancer who will be treated with laparoscopic surgical staging with SLN mapping.
According to inclusion and exclusion criteria, the patients will be randomized into two groups: the transvaginal paracervical lymphadenectomy group and the transperitoneal lymphadenectomy group.
Surgical Procedure of transvaginal paracervical sentinel lymphadenectomy group:
All patients(26) will receive V-NOTES with transvaginal paracervical sentinel lymph node (SLN) mapping followed by V-NOTES hysterectomy and bilateral salpingo-oophorectomy (BSO).
Transperitoneal sentinel lenfadenectomy group's Surgical Procedure:
All patients (26) will receive vNOTES hysterectomy with bilateral salpingo-oophorectomy (BSO) followed by transperitoneal vNOTES sentinel lymph node (SLN) mapping.
- Conditions
- Endometrial Cancer, Lymphadenectomy, Sentinel Lymph Node Biopsy, Minimally Invasive Surgical Procedures, Natural Orifice Transluminal Endoscopic Surgery
- Being tested
- Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomy, Transperitoneal lymphadenectomy
- Keywords
- endometrial cancer, V-NOTES, lymphadenectomy, sentinel lymph node, transperitoneal, extraperitoneal
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomyProcedure or surgery
The procedure begins with a vaginal incision in the lateral vaginal fornices (on both sides), which is then extended to allow placement of the V-NOTES apparatus. By identifying an appropriate cleavage plane, the obturator fossa is accessed to excise the obturator lymph nodes. Following this, an anterior colpotomy is performed to access the vesicocervical space, and a posterior colpotomy is made to open the rectouterine pouch. The V-NOTES apparatus is then placed to continue with the hysterectomy and bilateral salpingo-oophorectomy (BSO).
Transperitoneal lymphadenectomyProcedure or surgery
In this arm, patients will undergo transperitoneal lymphadenectomy with V-NOTES. The procedure begins with anterior and posterior colpotomies, followed by placement of the V-NOTES apparatus. Hysterectomy is performed first, followed by peritoneal dissection and lymph node excision.
| Study group | Role | What they receive |
|---|---|---|
| transvaginal paracervical sentinel lymphadenectomy group | Experimental | Surgical Procedure of transvaginal sentinel lymphadenectomy group:
All patients will be operated in accordance with Memorial Sloan Kettering Cancer Center procedure. V-NOTES will consist of transvaginal paracervical sentinel lymph node (SLN) mapping followed by V-NOTES hysterectomy and bilateral salpingo-oophorectomy (BSO).
SLN Mapping:
Under general anesthesia, subjects will be placed in supine lithotomy position. Methylene blue solution (BLUMET IV INJECTION INJECTABLE 50 mg/5 ml 1x5 ml) (1 mL submucosal to the cervix at the 3 and 9 o'clock positions and 1 mL at a depth of 1-2 cm, using a total volume of 2-4 mL.
Monitoring of lymphatic ducts includes identification of structures stained with methylene blue dye in the expected anatomical location, typically between the internal and external iliac veins or in the obturator region. Bilateral and symmetrical structures believed to be sentinel lymph nodes (SLNs) will be removed. When unilate Receives: Procedure: Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomy |
| Transperitoneal lymphadenectomy | Active comparator | In this arm, patients will undergo transperitoneal lymphadenectomy with V-NOTES. The procedure begins with methylene blue injection for sentinel lymph nodes. Methylene blue will be injected at the 3 and 9 o'clock positions on the cervix, first at a depth of 1 mm and then at 4 mm, with 1 cc administered at each point. This will result in a total of 4 cc (1 cc x 4). Then, the procedure will continue with anterior and posterior colpotomies, followed by placement of the V-NOTES apparatus. Hysterectomy is performed first, followed by peritoneal dissection and lymph node excision. Receives: Procedure: Transperitoneal lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total operation duration
The total duration of the operation in minutes
Measured: During surgery
Duration of right and left lymphadenectomy
The duration of lymphadenectomies in minutes
Measured: During surgery
Number of lymph nodes excised
Lymph node count in the pathology report
Measured: Postoperative second week
number of positive lymph nodes
Sentinel positive lymph nodes in the pathology report
Measured: Postoperative second week
Hospitalization duration
Number of days patients stayed at the hospital postoperatively
Measured: During hospital stay
Total bleeding volume
Measured by the suction bottle's volume and number of surgical gauzse used during surgery
Measured: During surgery
Difference between pre- and postoperative hemoglobin values
Hemoglobin level (g/dL)
Measured: Postoperative 1st day
Surgical complications
Clavien dindo scale of surgical complications
Measured: During hospital stay
Location o SLN
The area that sentinel lymph node detected internal iliac, external iliac ,bifurcation or obturator fossa
Measured: During surgery
Preoperative and postoperative hematocrit values
Hematocrit level (%)
Measured: During hospital stay
Tumor's patological features
Histophatology, grade, lymphovascular invasion, tumor diameter(cm), myometrial invasion, stage, total positive lymph node count
Measured: Postoperative second week
Management of complications
intraoperative and postoperative complication's management
Measured: through study completion
Duration of lateral colpotomy
at transvaginal retroperitoneal procedure ; before the lymphadenectomy we are making and incision to the lateral of cervix .this time describes the time that to reach the obturator fossa to pick the nodes.
Measured: During surgery
Duration of hysterectomy
minutes
Measured: During surgery
Sentinel lymphnode's side and number
number
Measured: Postoperative second week
Secondary outcomes (7)
Postoperative pain
visual analogue scale, higher scores indicate worse pain
Measured: 3rd and 6th month after operation
Sexual function
assessed by Female Sexual Function Index, higher scores indicate greater satisfaction
Measured: at postoperative 3rd and 6th month
Timing of passing gas
Bowel function
Measured: During hospital stay
Demographic features
Age, gravidity, parity, previous vaginal delivery, body-mass index
Measured: Postoperative second week
Previous abdominal surgery
Medical history
Measured: Preoperative day
Initiation of mobilization
After operation the time (hour) that paient is avaliable to mobilize out from the bed
Measured: During hospital stay
6th hour and 24th hour VAS score
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: postoperatively 6th and 24th hours score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start15 Mar 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Mar 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 Endometrial CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sedat Akgöl, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- Behzat Can, Assoc. Prof., Study chair, Health Sciences University Gazi Yasargil Training and Research HospitalSedat Akgol, Assoc. Prof., Study director, Health Sciences University Gazi Yasargil Training and Research HospitalKevser Arkan, MD, Principal investigator, Health Sciences University Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870903
- Sponsor's protocol ID
- ENDOCA
- Acronym
- ENDONOTE
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared.
Publications
Deng L, Liu Y, Yao Y, Deng Y, Tang S, Sun L, Wang Y. Efficacy of vaginal natural orifice transluminal endoscopic sentinel lymph node biopsy for endometrial cancer: a prospective multicenter cohort study. Int J Surg. 2023 Oct 1;109(10):2996-3002. doi: 10.1097/JS9.0000000000000551.
PubMed 37335988Can B, Akgol S, Adiguzel O, Kaya C. A new, less invasive approach for retroperitoneal pelvic and para-aortic lymphadenectomy combining the transvaginal natural orifice transluminal endoscopic surgery (vNOTES) technique and single-port laparoscopy. Int J Gynecol Cancer. 2024 May 6;34(5):789-790. doi: 10.1136/ijgc-2023-005093. No abstract available.
PubMed 38316443Baekelandt 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 38623778
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Transvaginal Paracervical and Transperitoneal Approaches in Lymphadenectomy During v-NOTES Surgery for Patients Diagnosed With Endometrial Cancer
- ClinicalTrials.gov ID
- NCT06870903
- Acronym / sponsor ID
- ENDONOTE / ENDOCA
- Conditions
- Endometrial Cancer, Lymphadenectomy, Sentinel Lymph Node Biopsy, Minimally Invasive Surgical Procedures, Natural Orifice Transluminal Endoscopic Surgery
- Keywords
- endometrial cancer, V-NOTES, lymphadenectomy, sentinel lymph node, transperitoneal, extraperitoneal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 11 Mar 2025 (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.
The aim of this study is to compare two types of lymphadenectomy (transperitoneal vs. paracervical) during the lymphadenectomy phase of endometrial cancer staging surgery performed using V-NOTES, a new and advanced technique. This study seeks to optimize the V-NOTES technique for endometrial cancer staging. This randomized, prospective, controlled study will include patients diagnosed with endometrial cancer via histology, following physical examination and imaging, and who are electively scheduled for the V-NOTES endometrial cancer staging procedure. Patients will be randomized into two groups: the transvaginal paracervical lymphadenectomy group and the transperitoneal lymphadenectomy group. The parameters related with surgical and functional outcomes will be compared in both groups.
Detailed description
Surgical staging is often the primary management strategy for endometrial cancer. Sentinel lymph node (SLN) procedures are considered an alternative standard of care in the treatment of significant uterus-confined malignancy. Both accurately estimate nodal status and reduce the surgical morbidity associated with complete lymphadenectomy. Laparoscopic surgery for endometrial cancer has been associated with equal or better quality of life, less blood loss and similar cancer-related outcomes. A new innovation, natural orifice transluminal endoscopic surgery (NOTES), has been developed to further reduce morbidity and scarring associated with laparoscopic surgery. NOTES utilizes the natural orifices of the human body for access to the peritoneal cavity when performing endoscopic surgery.
However, there is no standardization in vNOTES SLN mapping and lymph tracers are diverse. Many procedures and tracers have been reported, such as intra- or retroperitoneal surgery, a range of vaginal surgeries, SLN exposure method, and indocyanine green or methylene blue injection, and they lack comparative studies. This study will evaluate feasibility and surgical outcomes by comparing transvaginal paracervical and transperitoneal mapping in vNOTES hysterectomy with SLN procedure in endometrial cancer.
The study is an observational study with a prospective design. It will be implemented in a single institution, specifically Diyarbakır Gazi Yaşargil Training and Research Hospital, which functions as a tertiary cancer treatment facility.
Between March 2025 and December 2025, patients with newly diagnosed clinical early stage (FIGO 2023 stages 1 and 2) endometrial cancer who will be treated with laparoscopic surgical staging with SLN mapping.
According to inclusion and exclusion criteria, the patients will be randomized into two groups: the transvaginal paracervical lymphadenectomy group and the transperitoneal lymphadenectomy group.
Surgical Procedure of transvaginal paracervical sentinel lymphadenectomy group:
All patients(26) will receive V-NOTES with transvaginal paracervical sentinel lymph node (SLN) mapping followed by V-NOTES hysterectomy and bilateral salpingo-oophorectomy (BSO).
Transperitoneal sentinel lenfadenectomy group's Surgical Procedure:
All patients (26) will receive vNOTES hysterectomy with bilateral salpingo-oophorectomy (BSO) followed by transperitoneal vNOTES sentinel lymph node (SLN) mapping.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transvaginal paracervical sentinel lymphadenectomy group | Experimental | Procedure: Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomySurgical Procedure of transvaginal sentinel lymphadenectomy group: All patients will be operated in accordance with Memorial Sloan Kettering Cancer Center procedure. V-NOTES will consist of transvaginal paracervical sentinel lymph node (SLN) mapping followed by V-NOTES hysterectomy and bilateral salpingo-oophorectomy (BSO). SLN Mapping: Under general anesthesia, subjects will be placed in supine lithotomy position. Methylene blue solution (BLUMET IV INJECTION INJECTABLE 50 mg/5 ml 1x5 ml) (1 mL submucosal to the cervix at the 3 and 9 o'clock positions and 1 mL at a depth of 1-2 cm, using a total volume of 2-4 mL. Monitoring of lymphatic ducts includes identification of structures stained with methylene blue dye in the expected anatomical location, typically between the internal and external iliac veins or in the obturator region. Bilateral and symmetrical structures believed to be sentinel lymph nodes (SLNs) will be removed. When unilate |
| Transperitoneal lymphadenectomy | Active comparator | Procedure: Transperitoneal lymphadenectomyIn this arm, patients will undergo transperitoneal lymphadenectomy with V-NOTES. The procedure begins with methylene blue injection for sentinel lymph nodes. Methylene blue will be injected at the 3 and 9 o'clock positions on the cervix, first at a depth of 1 mm and then at 4 mm, with 1 cc administered at each point. This will result in a total of 4 cc (1 cc x 4). Then, the procedure will continue with anterior and posterior colpotomies, followed by placement of the V-NOTES apparatus. Hysterectomy is performed first, followed by peritoneal dissection and lymph node excision. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants whose endometrial biopsy resulted in endometrial cancer and whose disease will be detected limited to the uterus using imaging modalities (computed tomography [CT], magnetic resonance imaging or Fluorine-18 fluorodeoxyglucose positron emission tomography/CT)
- Absence of synchronous malignancies.
- No neoadjuvant treatment before surgical intervention.
Key exclusion criteria (4 listed)
- Contraindications to using methylene blue dye or contraindications to the vNOTES procedure.
- Patients who have had previous malignancy surgery.
- Severe, deeply penetrating endometriosis or enlarged uterus that may require forced vaginal extraction
- Receiving neodajuvant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomyThe procedure begins with a vaginal incision in the lateral vaginal fornices (on both sides), which is then extended to allow placement of the V-NOTES apparatus. By identifying an appropriate cleavage plane, the obturator fossa is accessed to excise the obturator lymph nodes. Following this, an anterior colpotomy is performed to access the vesicocervical space, and a posterior colpotomy is made to open the rectouterine pouch. The V-NOTES apparatus is then placed to continue with the hysterectomy and bilateral salpingo-oophorectomy (BSO). | Procedure or surgery | transvaginal paracervical sentinel lymphadenectomy group |
| Transperitoneal lymphadenectomyIn this arm, patients will undergo transperitoneal lymphadenectomy with V-NOTES. The procedure begins with anterior and posterior colpotomies, followed by placement of the V-NOTES apparatus. Hysterectomy is performed first, followed by peritoneal dissection and lymph node excision. | Procedure or surgery | Transperitoneal lymphadenectomy |
Primary outcome
Total operation duration
Time frame: During surgery
The total duration of the operation in minutes
Duration of right and left lymphadenectomy
Time frame: During surgery
The duration of lymphadenectomies in minutes
Number of lymph nodes excised
Time frame: Postoperative second week
Lymph node count in the pathology report
number of positive lymph nodes
Time frame: Postoperative second week
Sentinel positive lymph nodes in the pathology report
Hospitalization duration
Time frame: During hospital stay
Number of days patients stayed at the hospital postoperatively
Total bleeding volume
Time frame: During surgery
Measured by the suction bottle's volume and number of surgical gauzse used during surgery
Difference between pre- and postoperative hemoglobin values
Time frame: Postoperative 1st day
Hemoglobin level (g/dL)
Surgical complications
Time frame: During hospital stay
Clavien dindo scale of surgical complications
Location o SLN
Time frame: During surgery
The area that sentinel lymph node detected internal iliac, external iliac ,bifurcation or obturator fossa
Preoperative and postoperative hematocrit values
Time frame: During hospital stay
Hematocrit level (%)
Tumor's patological features
Time frame: Postoperative second week
Histophatology, grade, lymphovascular invasion, tumor diameter(cm), myometrial invasion, stage, total positive lymph node count
Management of complications
Time frame: through study completion
intraoperative and postoperative complication's management
Duration of lateral colpotomy
Time frame: During surgery
at transvaginal retroperitoneal procedure ; before the lymphadenectomy we are making and incision to the lateral of cervix .this time describes the time that to reach the obturator fossa to pick the nodes.
Duration of hysterectomy
Time frame: During surgery
minutes
Sentinel lymphnode's side and number
Time frame: Postoperative second week
number
7 secondary outcomes
Postoperative pain
Time frame: 3rd and 6th month after operation
Sexual function
Time frame: at postoperative 3rd and 6th month
Timing of passing gas
Time frame: During hospital stay
Demographic features
Time frame: Postoperative second week
Previous abdominal surgery
Time frame: Preoperative day
Initiation of mobilization
Time frame: During hospital stay
6th hour and 24th hour VAS score
Time frame: postoperatively 6th and 24th hours score
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 Mar 2025.
- Background: PubMed 37335988Deng L, Liu Y, Yao Y, Deng Y, Tang S, Sun L, Wang Y. Efficacy of vaginal natural orifice transluminal endoscopic sentinel lymph node biopsy for endometrial cancer: a prospective multicenter cohort study. Int J Surg. 2023 Oct 1;109(10):2996-3002. doi: 10.1097/JS9.0000000000000551.
- Background: PubMed 38316443Can B, Akgol S, Adiguzel O, Kaya C. A new, less invasive approach for retroperitoneal pelvic and para-aortic lymphadenectomy combining the transvaginal natural orifice transluminal endoscopic surgery (vNOTES) technique and single-port laparoscopy. Int J Gynecol Cancer. 2024 May 6;34(5):789-790. doi: 10.1136/ijgc-2023-005093. No abstract available.
- 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared.
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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.
Behzat Can, Assoc. Prof. study chair
Health Sciences University Gazi Yasargil Training and Research Hospital
Sedat Akgol, Assoc. Prof. study director
Health Sciences University Gazi Yasargil Training and Research Hospital
Kevser Arkan, MD principal investigator
Health Sciences University Gazi Yasargil Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extraperitoneal(transvaginal paracervical sentinel lymphadenectomy) group lymphadenectomy and Transperitoneal lymphadenectomy in people with Endometrial Cancer and Lymphadenectomy, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 Mar 2025. 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 Kevser Arkan, MD (+905536476838, kevser.toprak1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total operation duration (time frame: During surgery). The study lists 15 primary outcomes in all. 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 NCT06870903, 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 Mar 2025.