HysterectomyVNOTES-TLHNCT07306507
vNOTES vs Laparoscopic Hysterectomy: Randomized Trial on Pain and Recovery"
A study testing vNOTES Hysterectomy and Total Laparoscopic Hysterectomy in people with Hysterectomy, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study is a prospective, randomized controlled trial comparing two different minimally invasive hysterectomy techniques: vaginal natural orifice transluminal endoscopic surgery (vNOTES) and conventional total laparoscopic hysterectomy (TLH). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- vNOTES Hysterectomy and Total Laparoscopic Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jan 2026to 10 Apr 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
- Female patients aged 18 to 75 years
- ASA physical status I-II
- Scheduled for elective laparoscopic hysterectomy (benign indications such as myoma uteri, adenomyosis, endometrial hyperplasia)
- Able to understand study procedures and provide written informed consent
- Able to complete postoperative questionnaires (QoR-15 and Fatigue Assessment Scale)
Who cannot join
- ASA III-IV status
- Severe cardiopulmonary disease or contraindication to general anesthesia
- Coagulopathy or bleeding disorders
- Active pelvic infection
- History of extensive pelvic or abdominal surgery complicating minimally invasive access
- Cognitive impairment or inability to complete questionnaires
- Conversion to laparotomy
- Known allergy or intolerance to study medications (paracetamol, tramadol)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Diyarbakır, Turkey, 21070
About this study
Official title: Comparison of vNOTES and Conventional Laparoscopic Hysterectomy: A Randomized Controlled Study of Pain, Opioid Use, and Quality of Recovery
This study is a prospective, randomized controlled trial comparing two different minimally invasive hysterectomy techniques: vaginal natural orifice transluminal endoscopic surgery (vNOTES) and conventional total laparoscopic hysterectomy (TLH). The aim is to evaluate whether vNOTES provides better postoperative comfort and recovery by reducing pain, lowering opioid analgesic requirements, and improving early recovery outcomes.
Approximately 80 women undergoing elective hysterectomy will be randomly assigned to either vNOTES or TLH. All surgeries will be performed under standardized general anesthesia by the same experienced surgical team. Postoperative pain management will follow an identical protocol for all patients.
Primary outcomes include postoperative pain scores (at 12 and 24 hours) and total opioid consumption. Secondary outcomes include Quality of Recovery-15 (QoR-15) scores, fatigue scores, time to first mobilization, time to first flatus, and length of hospital stay. The results of this study may help identify which hysterectomy technique offers better patient-centered recovery and postoperative comfort.
Read the detailed description
This study is a single-center, prospective, randomized controlled clinical trial designed to compare two minimally invasive hysterectomy techniques: vaginal natural orifice transluminal endoscopic surgery (vNOTES) and conventional total laparoscopic hysterectomy (TLH). The aim is to determine whether vNOTES offers advantages in postoperative pain control, opioid requirements, and early recovery outcomes by eliminating abdominal wall incisions and reducing pneumoperitoneum-related physiological effects.
Eligible ASA I-II female patients aged 18-75 scheduled for elective hysterectomy are randomly assigned in a 1:1 ratio to the vNOTES or TLH group using a computer-generated sequence with sealed opaque envelopes for allocation concealment. All procedures are performed by the same experienced surgical and anesthesia team using a standardized general anesthesia protocol. Postoperative analgesia and recovery care are identical for both groups to ensure uniformity of perioperative management.
In the vNOTES group, hysterectomy is performed via transvaginal access using a self-retaining vaginal port, with pneumoperitoneum pressure kept at or below 15 mmHg. In the TLH group, a standard laparoscopic approach using a 10 mm umbilical port and two 5 mm accessory trocars is applied, with pneumoperitoneum maintained between 12-15 mmHg. Trendelenburg positioning is used in both techniques but is expected to be less steep and shorter in duration in the vNOTES group.
Outcome assessment is conducted by nurses and clinicians blinded to group allocation. Primary endpoints include postoperative pain scores at 12 and 24 hours (measured using a 0-10 Visual Analog Scale) and total opioid consumption within the first 24 hours. Secondary endpoints include Quality of Recovery-15 (QoR-15) scores, Fatigue Assessment Scale (FAS) scores, time to first mobilization, time to first flatus, length of hospital stay, and postoperative complications such as nausea/vomiting, shoulder pain, and respiratory discomfort. The study is powered based on a one-tailed hypothesis expecting lower postoperative discomfort in the vNOTES group.
The findings of this trial may help clarify whether vNOTES provides superior postoperative comfort and enhanced recovery compared to standard laparoscopic hysterectomy, contributing evidence to guide technique selection in minimally invasive gynecologic surgery.
- Conditions
- Hysterectomy
- Being tested
- vNOTES Hysterectomy, Total Laparoscopic Hysterectomy
- Keywords
- vNOTES, Total Laparoscopic Hysterectomy, Postoperative Pain, Enhanced Recovery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vNOTES HysterectomyProcedure or surgery
Transluminal endoscopic hysterectomy is performed through a vaginal natural opening via transvaginal access using a self-adhering vaginal port.
Total Laparoscopic HysterectomyProcedure or surgery
It is a conventional total laparoscopic hysterectomy performed using an umbilical cord port and two accessory trocars.
| Study group | Role | What they receive |
|---|---|---|
| vNOTES Group | Experimental | Patients undergo vaginal natural orifice transluminal endoscopic hysterectomy (vNOTES) using a transvaginal access port with a maximum pneumoperitoneum pressure not exceeding 15 mmHg. Receives: Procedure: vNOTES Hysterectomy |
| TLH Group | Active comparator | Patients undergo conventional total laparoscopic hysterectomy using a camera port and accessory trocars from the umbilicus, and pneumoperitoneum is maintained at a pressure not exceeding 15 mmHg. Receives: Procedure: Total Laparoscopic Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity (NRS)
Postoperative pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: At 12 and 24 hours postoperatively
Secondary outcomes (9)
Need for Rescue Analgesia Within 24 Hours
The proportion of patients requiring rescue analgesia (intravenous tramadol 100 mg) after the standard regimen (paracetamol intravenously every 8 hours) will be recorded along with the number of rescue doses per patient.
Measured: First 24 postoperative hours
Time to First Mobilization
Time from the end of surgery to the first ambulation out of bed will be recorded in hours.
Measured: From the end of surgery until the first ambulation out of bed, assessed up to 48 hours postoperatively.
Time to First Flatus
Time from the end of surgery to the first passage of flatus will be recorded in hours as an indicator of return of bowel function.
Measured: Time Frame: From the end of surgery until the first passage of flatus, assessed during the postoperative hospital stay, up to 7 days postoperatively or until hospital discharge, whichever comes first.
Length of Postoperative Hospital Stay
Length of stay will be calculated as the number of days from the day of surgery to the day of hospital discharge.
Measured: Time Frame: From the day of surgery until hospital discharge, assessed up to 30 days postoperatively or until discharge, whichever comes first.
Change in QoR-15 Score from Baseline to 24 Hours
The Quality of Recovery-15 (QoR-15) questionnaire (total score 0-150; higher scores indicate better recovery) will be administered preoperatively and at 24 hours postoperatively. The primary analysis will focus on the change in total score from baseline to 24 hours.
Measured: Time Frame: Preoperative (within 24 hours before surgery) and 24 hours postoperatively
Change in Fatigue Assessment Scale (FAS) Score from Baseline to 24 Hours
Fatigue will be evaluated using the Fatigue Assessment Scale (FAS; total score 10-50, higher scores indicate greater fatigue). The change in total score from baseline to 24 hours will be analyzed.
Measured: Preoperative (within 24 hours before surgery) and 24 hours postoperatively
Postoperative Nausea and Vomiting (PONV)
Postoperative nausea and vomiting will be recorded. Nausea severity will be assessed using a 0-10 Numeric Rating Scale (NRS), where 0 indicates no nausea and 10 indicates the worst imaginable nausea. Rescue antiemetic therapy will be administered if nausea severity is ≥4 or if vomiting occurs, and the need for rescue antiemetic treatment will be documented.
Measured: During the first 24 hours postoperatively
Postoperative Hemoglobin Decrease
Hemoglobin decrease will be calculated as the difference between preoperative hemoglobin level and postoperative hemoglobin level measured at 24 hours after surgery.
Measured: From preoperative baseline to 24 hours postoperatively
Postoperative Delirium and Acute Cognitive Dysfunction
Postoperative delirium and acute cognitive dysfunction will be assessed using the 4AT (4 'A's Test) screening tool within the first 24 hours after surgery. The 4AT evaluates four domains:
- Alertness (level of arousal),
- AMT4 (abbreviated mental test: age, date of birth, place, and current year),
- Attention (months of the year backwards),
- Acute change or fluctuating course.
Scores range from 0 to 12, with 0 indicating normal cognition, 1-3 suggesting possible cognitive impairment, and ≥4 indicating probable delirium. The incidence of postoperative delirium (4AT ≥4) and acute cognitive dysfunction (4AT ≥1) will be recorded and compared between the vNOTES and TLH groups.
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 posted29 Dec 2025
- Study start8 Jan 2026
- Primary completion9 Apr 2026
- Study completion10 Apr 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 HysterectomyStudies 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
- Participants will be randomly assigned in a 1:1 ratio to undergo either vNOTES hysterectomy or conventional total laparoscopic hysterectomy. Each participant receives only one of the two surgical interventions, and both groups are followed in parallel for outcome assessment.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 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
- NCT07306507
- Sponsor's protocol ID
- 11/7/2025-705
- Acronym
- VNOTES-TLH
- Status last verified
- Apr 2026
- First submitted
- 2 Dec 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fang S, Xia Y, Jin J, Zhang J, Lu L. Comparison of Surgical Outcomes Between Vaginally Assisted NOTES Hysterectomy and Laparoscopic Hysterectomy in Primary Hospitals: A Prospective Cohort Study. J Invest Surg. 2025 Dec;38(1):2515054. doi: 10.1080/08941939.2025.2515054. Epub 2025 Jun 10.
PubMed 40492370
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of vNOTES and Conventional Laparoscopic Hysterectomy: A Randomized Controlled Study of Pain, Opioid Use, and Quality of Recovery
- ClinicalTrials.gov ID
- NCT07306507
- Acronym / sponsor ID
- VNOTES-TLH / 11/7/2025-705
- Conditions
- Hysterectomy
- Keywords
- vNOTES, Total Laparoscopic Hysterectomy, Postoperative Pain, Enhanced Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 29 Dec 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.
This study is a prospective, randomized controlled trial comparing two different minimally invasive hysterectomy techniques: vaginal natural orifice transluminal endoscopic surgery (vNOTES) and conventional total laparoscopic hysterectomy (TLH). The aim is to evaluate whether vNOTES provides better postoperative comfort and recovery by reducing pain, lowering opioid analgesic requirements, and improving early recovery outcomes.
Approximately 80 women undergoing elective hysterectomy will be randomly assigned to either vNOTES or TLH. All surgeries will be performed under standardized general anesthesia by the same experienced surgical team. Postoperative pain management will follow an identical protocol for all patients.
Primary outcomes include postoperative pain scores (at 12 and 24 hours) and total opioid consumption. Secondary outcomes include Quality of Recovery-15 (QoR-15) scores, fatigue scores, time to first mobilization, time to first flatus, and length of hospital stay. The results of this study may help identify which hysterectomy technique offers better patient-centered recovery and postoperative comfort.
Detailed description
This study is a single-center, prospective, randomized controlled clinical trial designed to compare two minimally invasive hysterectomy techniques: vaginal natural orifice transluminal endoscopic surgery (vNOTES) and conventional total laparoscopic hysterectomy (TLH). The aim is to determine whether vNOTES offers advantages in postoperative pain control, opioid requirements, and early recovery outcomes by eliminating abdominal wall incisions and reducing pneumoperitoneum-related physiological effects.
Eligible ASA I-II female patients aged 18-75 scheduled for elective hysterectomy are randomly assigned in a 1:1 ratio to the vNOTES or TLH group using a computer-generated sequence with sealed opaque envelopes for allocation concealment. All procedures are performed by the same experienced surgical and anesthesia team using a standardized general anesthesia protocol. Postoperative analgesia and recovery care are identical for both groups to ensure uniformity of perioperative management.
In the vNOTES group, hysterectomy is performed via transvaginal access using a self-retaining vaginal port, with pneumoperitoneum pressure kept at or below 15 mmHg. In the TLH group, a standard laparoscopic approach using a 10 mm umbilical port and two 5 mm accessory trocars is applied, with pneumoperitoneum maintained between 12-15 mmHg. Trendelenburg positioning is used in both techniques but is expected to be less steep and shorter in duration in the vNOTES group.
Outcome assessment is conducted by nurses and clinicians blinded to group allocation. Primary endpoints include postoperative pain scores at 12 and 24 hours (measured using a 0-10 Visual Analog Scale) and total opioid consumption within the first 24 hours. Secondary endpoints include Quality of Recovery-15 (QoR-15) scores, Fatigue Assessment Scale (FAS) scores, time to first mobilization, time to first flatus, length of hospital stay, and postoperative complications such as nausea/vomiting, shoulder pain, and respiratory discomfort. The study is powered based on a one-tailed hypothesis expecting lower postoperative discomfort in the vNOTES group.
The findings of this trial may help clarify whether vNOTES provides superior postoperative comfort and enhanced recovery compared to standard laparoscopic hysterectomy, contributing evidence to guide technique selection in minimally invasive gynecologic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to undergo either vNOTES hysterectomy or conventional total laparoscopic hysterectomy. Each participant receives only one of the two surgical interventions, and both groups are followed in parallel for outcome assessment.
| Arm | Type | Receives |
|---|---|---|
| vNOTES Group | Experimental | Procedure: vNOTES HysterectomyPatients undergo vaginal natural orifice transluminal endoscopic hysterectomy (vNOTES) using a transvaginal access port with a maximum pneumoperitoneum pressure not exceeding 15 mmHg. |
| TLH Group | Active comparator | Procedure: Total Laparoscopic HysterectomyPatients undergo conventional total laparoscopic hysterectomy using a camera port and accessory trocars from the umbilicus, and pneumoperitoneum is maintained at a pressure not exceeding 15 mmHg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients aged 18 to 75 years
- ASA physical status I-II
- Scheduled for elective laparoscopic hysterectomy (benign indications such as myoma uteri, adenomyosis, endometrial hyperplasia)
- Able to understand study procedures and provide written informed consent
- Able to complete postoperative questionnaires (QoR-15 and Fatigue Assessment Scale)
Key exclusion criteria (8 listed)
- ASA III-IV status
- Severe cardiopulmonary disease or contraindication to general anesthesia
- Coagulopathy or bleeding disorders
- Active pelvic infection
- History of extensive pelvic or abdominal surgery complicating minimally invasive access
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 |
|---|---|---|
| vNOTES HysterectomyTransluminal endoscopic hysterectomy is performed through a vaginal natural opening via transvaginal access using a self-adhering vaginal port. | Procedure or surgery | vNOTES Group |
| Total Laparoscopic HysterectomyIt is a conventional total laparoscopic hysterectomy performed using an umbilical cord port and two accessory trocars. | Procedure or surgery | TLH Group |
Primary outcome
Postoperative Pain Intensity (NRS)
Time frame: At 12 and 24 hours postoperatively
Postoperative pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
9 secondary outcomes
Need for Rescue Analgesia Within 24 Hours
Time frame: First 24 postoperative hours
Time to First Mobilization
Time frame: From the end of surgery until the first ambulation out of bed, assessed up to 48 hours postoperatively.
Time to First Flatus
Time frame: Time Frame: From the end of surgery until the first passage of flatus, assessed during the postoperative hospital stay, up to 7 days postoperatively or until hospital discharge, whichever comes first.
Length of Postoperative Hospital Stay
Time frame: Time Frame: From the day of surgery until hospital discharge, assessed up to 30 days postoperatively or until discharge, whichever comes first.
Change in QoR-15 Score from Baseline to 24 Hours
Time frame: Time Frame: Preoperative (within 24 hours before surgery) and 24 hours postoperatively
Change in Fatigue Assessment Scale (FAS) Score from Baseline to 24 Hours
Time frame: Preoperative (within 24 hours before surgery) and 24 hours postoperatively
Postoperative Nausea and Vomiting (PONV)
Time frame: During the first 24 hours postoperatively
Postoperative Hemoglobin Decrease
Time frame: From preoperative baseline to 24 hours postoperatively
Postoperative Delirium and Acute Cognitive Dysfunction
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 15 Apr 2026.
- Background: PubMed 40492370Fang S, Xia Y, Jin J, Zhang J, Lu L. Comparison of Surgical Outcomes Between Vaginally Assisted NOTES Hysterectomy and Laparoscopic Hysterectomy in Primary Hospitals: A Prospective Cohort Study. J Invest Surg. 2025 Dec;38(1):2515054. doi: 10.1080/08941939.2025.2515054. Epub 2025 Jun 10.
- Individual participant dataSharing planned: Undecided
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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 Hysterectomy and Total Laparoscopic Hysterectomy in people with Hysterectomy, 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 5 inclusion and 8 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 15 Apr 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?
Postoperative Pain Intensity (NRS) (time frame: At 12 and 24 hours postoperatively). 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 NCT07306507, 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 15 Apr 2026.