Endometrial CancerNCT07250178
ONSD as an ICP Marker in vNOTES and TLH
A study testing vNOTES and TLH in people with Endometrial Cancer and Abnormal Uterine Bleeding, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients undergoing conventional total laparoscopic hysterectomy (TLH) are typically placed in the Trendelenburg position with intraabdominal carbon dioxide (CO₂) insufflation. These factors may contribute to intraoperative complications such as lymphedema, impaired pulmonary function, and increased intracranial… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Endometrial Cancer, Abnormal Uterine Bleeding, Myoma;Uterus
- What is being tested?
- vNOTES and TLH
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Nov 2025to 5 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- voluntary participation,
- elective laparoscopic hysterectomy scheduled by gynecology-oncology specialists,
- ASA physical status I-II
Who cannot join
- included unwillingness to participate,
- emergency surgery,
- age <18 years,
- prior major pelvic or abdominal surgery,
- ASA ≥III,
- Chronic pulmonary disease, pulmonary hypertension, glaucoma, diabetic retinopathy, intracranial pathology (mass, hydrocephalus, optic neuritis), prior ocular or intracranial surgery, cardiac failure (EF <40%), active infection, or systemic inflammatory diseases other than malignancy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Diyarbakır, Outside of the US, 21070
About this study
Official title: Effect of Surgical Approach on Optic Nerve Sheath Diameter as a Surrogate Marker of Intracranial Pressure: A Comparison Between vNOTES and Total Laparoscopic Hysterectomy
Patients undergoing conventional total laparoscopic hysterectomy (TLH) are typically placed in the Trendelenburg position with intraabdominal carbon dioxide (CO₂) insufflation. These factors may contribute to intraoperative complications such as lymphedema, impaired pulmonary function, and increased intracranial pressure.
Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES), a novel minimally invasive technique, provides retroperitoneal or transperitoneal access through the vaginal route and offers the potential for shorter operative times and lower intraabdominal pressure requirements.
This study aims to evaluate whether the vNOTES technique can reduce intraoperative and postoperative complications compared with TLH. Particular attention will be given to hemodynamic parameters and changes in optic nerve sheath diameter as an indirect indicator of intracranial pressure.
Read the detailed description
This study is designed as a single-center, prospective, randomized controlled trial conducted at the Gynecologic Oncology Clinic of Health Sciences University Diyarbakır Gazi Yaşargil Training and Research Hospital. Eligible patients will be women between 18 and 75 years of age, classified as ASA I-II, who are scheduled for elective laparoscopic hysterectomy for gynecologic oncology indications. The study protocol will be initiated after approval by the institutional ethics committee, and written informed consent will be obtained from all participants.
Group vNOTES: Following vaginal exposure with a speculum under general anesthesia, entry will be performed through the posterior vaginal fornix. After posterior colpotomy, the vNOTES port system will be inserted. Pneumoperitoneum will be established with CO₂ insufflation at a maximum pressure of 15 mmHg. The operation will be performed using an endoscopic camera and working channels.
Group TLH: Under general anesthesia, pneumoperitoneum will be created via an umbilical trocar (maximum pressure15 mmHg), followed by placement of 2-3 additional trocars in the lower abdomen. A standard total laparoscopic hysterectomy will then be performed.
Demographic and perioperative data will be collected, including age, diagnosis, ASA score, anesthesia and surgery duration, intraoperative blood loss (by suction and sponge count), total intravenous fluids, systolic and diastolic blood pressure, heart rate, oxygen saturation, respiratory rate, end-tidal CO₂, intra-abdominal pressure, and ventilatory parameters (PEEP, peak and plateau airway pressures).
The primary outcome will be changes in optic nerve sheath diameter (ONSD), measured by ultrasonography at predefined time points as a surrogate marker of intracranial pressure:
T0: before induction of anesthesia
T1: at 10 minutes after Trendelenburg positioning and insufflation
T2: at 30 minutes
T3: at 60 minutes
T4: at 90 minutes
T5: 10 minutes after desufflation and return to neutral position
All ONSD measurements will be performed intraoperatively by a trained anesthesiologist using standardized ultrasound techniques. Hemodynamic and ventilatory parameters will be recorded at 10-minute intervals.
Secondary outcomes will include arterial blood gas analysis, postoperative complications (such as nausea, vomiting, delirium, headache, dizziness, and diplopia), and recovery variables (time to ambulation, return of bowel function, oral intake, and hospital stay).
Among the parameters measured, ONSD evaluation via ultrasound is specific to the study and non-invasive, adding no risk or cost to the patient. All other parameters are part of routine intraoperative monitoring. Data collection will be carried out in the operating room by anesthesiologists and trained ICU/gynecologic oncology nurses.
The investigators hypothesize that the vNOTES approach, due to its shorter operative duration, reduced Trendelenburg requirements, and lower intraabdominal insufflation pressures, will result in less pronounced increases in ONSD compared with TLH. This may lead to greater intraoperative stability and reduced postoperative complications, thereby providing valuable evidence for optimizing surgical strategies in gynecologic oncology.
- Conditions
- Endometrial Cancer, Abnormal Uterine Bleeding, Myoma;Uterus
- Being tested
- vNOTES, TLH
- Keywords
- Laparoscopic Hysterectomy, vNOTES, Optic Nerve Sheath Diameter, Intracranial Pressure
- Medical subject headings
- Endometrial Neoplasms, Metrorrhagia, Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vNOTESProcedure or surgery
vNOTES: In the vNOTES group, the surgery was performed using a transvaginal approach with a self-retaining vaginal port. Following colpotomy, CO₂ insufflation was applied through the vaginal port, ensuring intra-abdominal pressure did not exceed 15 mmHg. The procedure involved occlusion and ligation of the uterine artery under direct endoscopic visualization, followed by sampling through the vaginal route. Pneumoperitoneum was released before closing the vaginal vault. The uterus was then removed through the vaginal route.
TLHProcedure or surgery
In the TLH group, the surgical procedure was performed under standard laparoscopic conditions using a 10 mm umbilical camera port and two 5 mm accessory trocars. CO₂ insufflation was initiated to maintain intra-abdominal pressure below 15 mmHg. The uterus is dissected using a bipolar vessel sealing device, and the specimen is removed transvaginally. The vaginal cuff and abdominal trocar entries are sutured laparoscopically under direct visualization.
| Study group | Role | What they receive |
|---|---|---|
| vNOTES Hysterectomy for Assessment of Intraoperative Optic Nerve Sheath Diameter | Experimental | Vajinal natural orifice transluminal endoscopic surgery (vNOTES): In the vNOTES group, the surgery was performed using a transvaginal approach with a self-retaining vaginal port. Following colpotomy, CO₂ insufflation was applied through the vaginal port, ensuring intra-abdominal pressure did not exceed 15 mmHg. The procedure involved occlusion and ligation of the uterine artery under direct endoscopic visualization, followed by sampling through the vaginal route. Pneumoperitoneum was released before closing the vaginal vault. The uterus was then removed through the vaginal route. Receives: Procedure: vNOTES |
| Total Laparoscopic Hysterectomy for Assessment of Intraoperative Optic Nerve Sheath Diameter | Active comparator | Total laparoscopic hysterectomy (TLH): In the TLH group, the surgical procedure was performed under standard laparoscopic conditions using a 10 mm umbilical camera port and two 5 mm accessory trocars. CO₂ insufflation was initiated to maintain intra-abdominal pressure below 15 mmHg. The uterus is dissected using a bipolar vessel sealing device, and the specimen is removed transvaginally. The vaginal cuff and abdominal trocar entries are sutured laparoscopically under direct visualization. Receives: Procedure: TLH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter (ONSD) measured
All measurements were performed using a high-resolution ultrasound device equipped with a 7-13 MHz linear probe. The ultrasound gain and depth settings were standardized for all patients (depth: 4-5 cm; focus: at the level of the optic disc). Patient Position: Measurements were obtained with patients in the supine position. The eyes were kept closed, and sterile ultrasound gel was applied without exerting pressure on the globe. The probe was gently placed on the upper eyelid, and measurements were taken in the transverse plane. The optic nerve sheath diameter was measured 3 mm distal to the optic disc, from outer edge to outer edge (outer-to-outer).
Measured: From baseline (before induction) to 10, 30, 60, and 90 minutes after Trendelenburg and CO₂ insufflation, and 10 minutes after desufflation.
Secondary outcomes (9)
Blood pressure measurement
Systolic, diastolic and mean arterial pressure measurements will be recorded by invasive arterial monitoring.
Measured: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
Measurement of heart rate
The number of heart beats per minute obtained by electrocardiographic monitoring
Measured: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
intraabdominal pressure
The pressure inside the abdominal cavity during CO₂ insufflation.
Measured: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
end-tidal CO₂ (EtCO₂)
The partial pressure of CO₂ at end-expiration measured by capnography
Measured: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
peak airway pressure
The highest pressure reached in the airways during inspiration under mechanical ventilation.
Measured: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
Nausea-vomiting
Questioning about the presence/absence of nausea and/or vomiting in the postoperative period
Measured: During the 24 hours postoperative period
dizziness
Questioning about the presence/absence of dizzines the postoperative period
Measured: During the 24 hours postoperative period
diplopia
Questioning about the presence/absence of diplopia the postoperative period
Measured: During the 24 hours postoperative period
Incidence of Postoperative Headache
The incidence of postoperative headache will be recorded within the first 24 hours after surgery. Headache will be assessed by direct patient questioning and documented as present or absent.
Measured: Within the first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start27 Nov 2025
- Primary completion2 Jan 2026
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Model description
- This is a single-center, prospective, randomized controlled trial with a parallel assignment design. Eligible patients undergoing elective laparoscopic hysterectomy will be randomly allocated in a 1:1 ratio to either the vNOTES group or the TLH group. Randomization will be performed using a computer-generated sequence, and allocation concealment will be maintained with sealed opaque envelopes. Each participant will receive only one surgical intervention.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Acil,MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- Fatma Acil, M.D., Principal investigator, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250178
- Sponsor's protocol ID
- 09/05/2025-627
- Status last verified
- Jan 2026
- First submitted
- 18 Nov 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including baseline demographic variables and primary/secondary outcome measures, will be shared.
Publications
Guloglu H, Cetinkaya D, Oge T, Bilir A. Evaluation of the effect of trendelenburg position duration on intracranial pressure in laparoscopic hysterectomies using ultrasonographic optic nerve sheath diameter measurements. BMC Anesthesiol. 2024 Jul 15;24(1):238. doi: 10.1186/s12871-024-02624-4.
PubMed 39010013
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Surgical Approach on Optic Nerve Sheath Diameter as a Surrogate Marker of Intracranial Pressure: A Comparison Between vNOTES and Total Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT07250178
- Acronym / sponsor ID
- 09/05/2025-627
- Conditions
- Endometrial Cancer, Abnormal Uterine Bleeding, Myoma;Uterus
- Keywords
- Laparoscopic Hysterectomy, vNOTES, Optic Nerve Sheath Diameter, Intracranial Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- 2 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 26 Nov 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.
Patients undergoing conventional total laparoscopic hysterectomy (TLH) are typically placed in the Trendelenburg position with intraabdominal carbon dioxide (CO₂) insufflation. These factors may contribute to intraoperative complications such as lymphedema, impaired pulmonary function, and increased intracranial pressure.
Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES), a novel minimally invasive technique, provides retroperitoneal or transperitoneal access through the vaginal route and offers the potential for shorter operative times and lower intraabdominal pressure requirements.
This study aims to evaluate whether the vNOTES technique can reduce intraoperative and postoperative complications compared with TLH. Particular attention will be given to hemodynamic parameters and changes in optic nerve sheath diameter as an indirect indicator of intracranial pressure.
Detailed description
This study is designed as a single-center, prospective, randomized controlled trial conducted at the Gynecologic Oncology Clinic of Health Sciences University Diyarbakır Gazi Yaşargil Training and Research Hospital. Eligible patients will be women between 18 and 75 years of age, classified as ASA I-II, who are scheduled for elective laparoscopic hysterectomy for gynecologic oncology indications. The study protocol will be initiated after approval by the institutional ethics committee, and written informed consent will be obtained from all participants.
Group vNOTES: Following vaginal exposure with a speculum under general anesthesia, entry will be performed through the posterior vaginal fornix. After posterior colpotomy, the vNOTES port system will be inserted. Pneumoperitoneum will be established with CO₂ insufflation at a maximum pressure of 15 mmHg. The operation will be performed using an endoscopic camera and working channels.
Group TLH: Under general anesthesia, pneumoperitoneum will be created via an umbilical trocar (maximum pressure15 mmHg), followed by placement of 2-3 additional trocars in the lower abdomen. A standard total laparoscopic hysterectomy will then be performed.
Demographic and perioperative data will be collected, including age, diagnosis, ASA score, anesthesia and surgery duration, intraoperative blood loss (by suction and sponge count), total intravenous fluids, systolic and diastolic blood pressure, heart rate, oxygen saturation, respiratory rate, end-tidal CO₂, intra-abdominal pressure, and ventilatory parameters (PEEP, peak and plateau airway pressures).
The primary outcome will be changes in optic nerve sheath diameter (ONSD), measured by ultrasonography at predefined time points as a surrogate marker of intracranial pressure:
T0: before induction of anesthesia
T1: at 10 minutes after Trendelenburg positioning and insufflation
T2: at 30 minutes
T3: at 60 minutes
T4: at 90 minutes
T5: 10 minutes after desufflation and return to neutral position
All ONSD measurements will be performed intraoperatively by a trained anesthesiologist using standardized ultrasound techniques. Hemodynamic and ventilatory parameters will be recorded at 10-minute intervals.
Secondary outcomes will include arterial blood gas analysis, postoperative complications (such as nausea, vomiting, delirium, headache, dizziness, and diplopia), and recovery variables (time to ambulation, return of bowel function, oral intake, and hospital stay).
Among the parameters measured, ONSD evaluation via ultrasound is specific to the study and non-invasive, adding no risk or cost to the patient. All other parameters are part of routine intraoperative monitoring. Data collection will be carried out in the operating room by anesthesiologists and trained ICU/gynecologic oncology nurses.
The investigators hypothesize that the vNOTES approach, due to its shorter operative duration, reduced Trendelenburg requirements, and lower intraabdominal insufflation pressures, will result in less pronounced increases in ONSD compared with TLH. This may lead to greater intraoperative stability and reduced postoperative complications, thereby providing valuable evidence for optimizing surgical strategies in gynecologic oncology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-center, prospective, randomized controlled trial with a parallel assignment design. Eligible patients undergoing elective laparoscopic hysterectomy will be randomly allocated in a 1:1 ratio to either the vNOTES group or the TLH group. Randomization will be performed using a computer-generated sequence, and allocation concealment will be maintained with sealed opaque envelopes. Each participant will receive only one surgical intervention.
| Arm | Type | Receives |
|---|---|---|
| vNOTES Hysterectomy for Assessment of Intraoperative Optic Nerve Sheath Diameter | Experimental | Procedure: vNOTESVajinal natural orifice transluminal endoscopic surgery (vNOTES): In the vNOTES group, the surgery was performed using a transvaginal approach with a self-retaining vaginal port. Following colpotomy, CO₂ insufflation was applied through the vaginal port, ensuring intra-abdominal pressure did not exceed 15 mmHg. The procedure involved occlusion and ligation of the uterine artery under direct endoscopic visualization, followed by sampling through the vaginal route. Pneumoperitoneum was released before closing the vaginal vault. The uterus was then removed through the vaginal route. |
| Total Laparoscopic Hysterectomy for Assessment of Intraoperative Optic Nerve Sheath Diameter | Active comparator | Procedure: TLHTotal laparoscopic hysterectomy (TLH): In the TLH group, the surgical procedure was performed under standard laparoscopic conditions using a 10 mm umbilical camera port and two 5 mm accessory trocars. CO₂ insufflation was initiated to maintain intra-abdominal pressure below 15 mmHg. The uterus is dissected using a bipolar vessel sealing device, and the specimen is removed transvaginally. The vaginal cuff and abdominal trocar entries are sutured laparoscopically under direct visualization. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- voluntary participation,
- elective laparoscopic hysterectomy scheduled by gynecology-oncology specialists,
- ASA physical status I-II
Key exclusion criteria (6 listed)
- included unwillingness to participate,
- emergency surgery,
- age <18 years,
- prior major pelvic or abdominal surgery,
- ASA ≥III,
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 |
|---|---|---|
| vNOTESvNOTES: In the vNOTES group, the surgery was performed using a transvaginal approach with a self-retaining vaginal port. Following colpotomy, CO₂ insufflation was applied through the vaginal port, ensuring intra-abdominal pressure did not exceed 15 mmHg. The procedure involved occlusion and ligation of the uterine artery under direct endoscopic visualization, followed by sampling through the vaginal route. Pneumoperitoneum was released before closing the vaginal vault. The uterus was then removed through the vaginal route. | Procedure or surgery | vNOTES Hysterectomy for Assessment of Intraoperative Optic Nerve Sheath Diameter |
| TLHIn the TLH group, the surgical procedure was performed under standard laparoscopic conditions using a 10 mm umbilical camera port and two 5 mm accessory trocars. CO₂ insufflation was initiated to maintain intra-abdominal pressure below 15 mmHg. The uterus is dissected using a bipolar vessel sealing device, and the specimen is removed transvaginally. The vaginal cuff and abdominal trocar entries are sutured laparoscopically under direct visualization. | Procedure or surgery | Total Laparoscopic Hysterectomy for Assessment of Intraoperative Optic Nerve Sheath Diameter |
Primary outcome
Optic nerve sheath diameter (ONSD) measured
Time frame: From baseline (before induction) to 10, 30, 60, and 90 minutes after Trendelenburg and CO₂ insufflation, and 10 minutes after desufflation.
All measurements were performed using a high-resolution ultrasound device equipped with a 7-13 MHz linear probe. The ultrasound gain and depth settings were standardized for all patients (depth: 4-5 cm; focus: at the level of the optic disc). Patient Position: Measurements were obtained with patients in the supine position. The eyes were kept closed, and sterile ultrasound gel was applied without exerting pressure on the globe. The probe was gently placed on the upper eyelid, and measurements were taken in the transverse plane. The optic nerve sheath diameter was measured 3 mm distal to the optic disc, from outer edge to outer edge (outer-to-outer).
9 secondary outcomes
Blood pressure measurement
Time frame: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
Measurement of heart rate
Time frame: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
intraabdominal pressure
Time frame: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
end-tidal CO₂ (EtCO₂)
Time frame: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
peak airway pressure
Time frame: It will be recorded 10 minutes before induction of anesthesia and every 15 minutes after intubation until the end of the operation.
Nausea-vomiting
Time frame: During the 24 hours postoperative period
dizziness
Time frame: During the 24 hours postoperative period
diplopia
Time frame: During the 24 hours postoperative period
Incidence of Postoperative Headache
Time frame: Within the first 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Background: PubMed 39010013Guloglu H, Cetinkaya D, Oge T, Bilir A. Evaluation of the effect of trendelenburg position duration on intracranial pressure in laparoscopic hysterectomies using ultrasonographic optic nerve sheath diameter measurements. BMC Anesthesiol. 2024 Jul 15;24(1):238. doi: 10.1186/s12871-024-02624-4.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including baseline demographic variables and primary/secondary outcome measures, 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. This study is not recruiting at the moment.
Fatma Acil, M.D. principal investigator
Saglik Bilimleri Universitesi 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 vNOTES and TLH in people with Endometrial Cancer and Abnormal Uterine Bleeding, 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 6 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: finished, as of the sponsor's last update on 7 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Optic nerve sheath diameter (ONSD) measured (time frame: From baseline (before induction) to 10, 30, 60, and 90 minutes after Trendelenburg and CO₂ insufflation, and 10 minutes after desufflation.). 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 NCT07250178, which also lists 1 linked publication.
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 7 Jan 2026.