Hysterectomy, Benign Uterine DiseasesNCT07846670
vNOTES Versus Vaginal Hysterectomy for Benign Gynecologic Indications
A study testing vNOTES Hysterectomy and Vaginal Hysterectomy in people with Hysterectomy, Benign Uterine Diseases, run by Hatice Nur ÖZGEN at 1 site in Turkey (Türkiye).
Trial summary
This randomized non-inferiority trial aims to compare early and late postoperative outcomes of transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy and vaginal hysterectomy in women undergoing hysterectomy for benign gynecological indications. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Hysterectomy, Benign Uterine Diseases
- What is being tested?
- vNOTES Hysterectomy and Vaginal Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2026to 31 Dec 2027
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18-65 years. Presence of an indication for hysterectomy due to benign gynecological conditions (uterine leiomyoma, adenomyosis, treatment-resistant abnormal uterine bleeding, endometrial polyp, non-atypical endometrial hyperplasia, or high-grade cervical intraepithelial neoplasia).
- Uterine size corresponding to ≤14 weeks of gestation. Mobile uterus on gynecological examination. Vaginal access suitable for surgical intervention (absence of vaginal stenosis or severe anatomical restrictions).
- Considered eligible for both vaginal hysterectomy and vNOTES hysterectomy during preoperative evaluation.
- Provision of written informed consent.
Who cannot join
- Confirmed or suspected gynecological malignancy. Active pelvic inflammatory disease or lower genital tract infection. History of rectal surgery or suspicion of rectovaginal endometriosis. Severe endometriosis or obliteration of the posterior cul-de-sac on pelvic examination.
- Stage III-IV uterine prolapse according to the International Continence Society (ICS) classification.
- Anatomical conditions that severely restrict vaginal access. Pregnancy or virginity.
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
Harran University Hospital
Sanliurfa, Şanlıurfa, 63300
Hatice N ÖZGEN, PhD, +90-505-494-40-88, haticenurozgen@harran.edu.tr
Hatice N ÖZGEN, PhD
About this study
Official title: Comparison of Early and Late Postoperative Outcomes of vNOTES and Vaginal Hysterectomy in Benign Gynecological Indications: A Randomized Non-Inferiority Trial
This randomized non-inferiority trial aims to compare early and late postoperative outcomes of transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy and vaginal hysterectomy in women undergoing hysterectomy for benign gynecological indications. Eligible participants will be randomly assigned to either vNOTES hysterectomy or vaginal hysterectomy. The primary outcome is postoperative pain at 24 hours measured by the Visual Analog Scale (VAS). Secondary outcomes include postoperative recovery, complications, length of hospital stay, return of bowel function, urinary catheter duration, readmission, and recovery index scores. The study will be conducted at Harran University Hospital.
Read the detailed description
This prospective, randomized, non-inferiority controlled trial is designed to compare transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy and vaginal hysterectomy in women with benign gynecological indications requiring hysterectomy.
The study will be conducted at Harran University Hospital after ethics committee approval and clinical trial registration. Eligible participants will include women aged 18-65 years who are suitable candidates for both surgical techniques. Patients with gynecological malignancy, severe endometriosis, advanced uterine prolapse, pregnancy, active pelvic infection, or high surgical risk will be excluded.
Participants will be randomized in a 1:1 ratio to either the vNOTES hysterectomy group or the vaginal hysterectomy group using computer-based block randomization. All surgical procedures will be performed by an experienced surgeon. Although blinding of surgeons and participants is not feasible, postoperative outcome assessments and statistical analyses will be conducted by blinded researchers.
The primary outcome measure is postoperative pain at 24 hours assessed using the Visual Analog Scale (VAS). Secondary outcomes include postoperative recovery, return of bowel motility, urinary catheter duration, hospital stay, postoperative complications according to the Clavien-Dindo classification, readmission rates, and postoperative recovery index scores.
Data will be collected during the preoperative, intraoperative, and postoperative periods using standardized forms. Patients will be evaluated on postoperative day 0, day 1, day 7, and at postoperative month 1.
Statistical analyses will be performed using SPSS software. Appropriate parametric or non-parametric tests will be used according to data distribution. Non-inferiority analysis will be performed using the 95% confidence interval of the between-group difference for the primary outcome.
- Conditions
- Hysterectomy, Benign Uterine Diseases
- Being tested
- vNOTES Hysterectomy, Vaginal Hysterectomy
- Keywords
- vNOTES, Vaginal Hysterectomy, Benign Gynecologic Disease, Postoperative Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vNOTES HysterectomyProcedure or surgery
Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy performed for benign gynecologic indications. The procedure is conducted through a transvaginal endoscopic approach without abdominal incisions and is compared with conventional vaginal hysterectomy.
Vaginal HysterectomyProcedure or surgery
Conventional vaginal hysterectomy performed for benign gynecologic indications using the standard vaginal surgical approach.
| Study group | Role | What they receive |
|---|---|---|
| vNOTES Hysterectomy | Experimental | Participants undergo hysterectomy using the transvaginal natural orifice transluminal endoscopic surgery (vNOTES) technique. Receives: Procedure: vNOTES Hysterectomy |
| Vaginal Hysterectomy | Active comparator | Participants undergo conventional vaginal hysterectomy using the standard vaginal surgical approach. Receives: Procedure: Vaginal Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
Postoperative pain will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start20 Apr 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hysterectomy, Benign Uterine DiseasesStudies 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hatice Nur ÖZGEN
- Sponsor type
- University, hospital or other
- Collaborators
- Harran University
- Responsible party
- Sponsor-investigator, Hatice Nur ÖZGEN, Harran University
- Investigators
- Fatma KORUK, PhD, Study director, Harran University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846670
- Sponsor's protocol ID
- HRU-VNOTES-RCT-2026
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early and Late Postoperative Outcomes of vNOTES and Vaginal Hysterectomy in Benign Gynecological Indications: A Randomized Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07846670
- Acronym / sponsor ID
- HRU-VNOTES-RCT-2026
- Conditions
- Hysterectomy, Benign Uterine Diseases
- Keywords
- vNOTES, Vaginal Hysterectomy, Benign Gynecologic Disease, Postoperative Outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hatice Nur ÖZGENUniversity, hospital or other
- Collaborators
- Harran University
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized non-inferiority trial aims to compare early and late postoperative outcomes of transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy and vaginal hysterectomy in women undergoing hysterectomy for benign gynecological indications. Eligible participants will be randomly assigned to either vNOTES hysterectomy or vaginal hysterectomy. The primary outcome is postoperative pain at 24 hours measured by the Visual Analog Scale (VAS). Secondary outcomes include postoperative recovery, complications, length of hospital stay, return of bowel function, urinary catheter duration, readmission, and recovery index scores. The study will be conducted at Harran University Hospital.
Detailed description
This prospective, randomized, non-inferiority controlled trial is designed to compare transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy and vaginal hysterectomy in women with benign gynecological indications requiring hysterectomy.
The study will be conducted at Harran University Hospital after ethics committee approval and clinical trial registration. Eligible participants will include women aged 18-65 years who are suitable candidates for both surgical techniques. Patients with gynecological malignancy, severe endometriosis, advanced uterine prolapse, pregnancy, active pelvic infection, or high surgical risk will be excluded.
Participants will be randomized in a 1:1 ratio to either the vNOTES hysterectomy group or the vaginal hysterectomy group using computer-based block randomization. All surgical procedures will be performed by an experienced surgeon. Although blinding of surgeons and participants is not feasible, postoperative outcome assessments and statistical analyses will be conducted by blinded researchers.
The primary outcome measure is postoperative pain at 24 hours assessed using the Visual Analog Scale (VAS). Secondary outcomes include postoperative recovery, return of bowel motility, urinary catheter duration, hospital stay, postoperative complications according to the Clavien-Dindo classification, readmission rates, and postoperative recovery index scores.
Data will be collected during the preoperative, intraoperative, and postoperative periods using standardized forms. Patients will be evaluated on postoperative day 0, day 1, day 7, and at postoperative month 1.
Statistical analyses will be performed using SPSS software. Appropriate parametric or non-parametric tests will be used according to data distribution. Non-inferiority analysis will be performed using the 95% confidence interval of the between-group difference for the primary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vNOTES Hysterectomy | Experimental | Procedure: vNOTES HysterectomyParticipants undergo hysterectomy using the transvaginal natural orifice transluminal endoscopic surgery (vNOTES) technique. |
| Vaginal Hysterectomy | Active comparator | Procedure: Vaginal HysterectomyParticipants undergo conventional vaginal hysterectomy using the standard vaginal surgical approach. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged 18-65 years. Presence of an indication for hysterectomy due to benign gynecological conditions (uterine leiomyoma, adenomyosis, treatment-resistant abnormal uterine bleeding, endometrial polyp, non-atypical endometrial hyperplasia, or high-grade cervical intraepithelial neoplasia).
- Uterine size corresponding to ≤14 weeks of gestation. Mobile uterus on gynecological examination. Vaginal access suitable for surgical intervention (absence of vaginal stenosis or severe anatomical restrictions).
- Considered eligible for both vaginal hysterectomy and vNOTES hysterectomy during preoperative evaluation.
- Provision of written informed consent.
Key exclusion criteria (3 listed)
- Confirmed or suspected gynecological malignancy. Active pelvic inflammatory disease or lower genital tract infection. History of rectal surgery or suspicion of rectovaginal endometriosis. Severe endometriosis or obliteration of the posterior cul-de-sac on pelvic examination.
- Stage III-IV uterine prolapse according to the International Continence Society (ICS) classification.
- Anatomical conditions that severely restrict vaginal access. Pregnancy or virginity.
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 HysterectomyTransvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy performed for benign gynecologic indications. The procedure is conducted through a transvaginal endoscopic approach without abdominal incisions and is compared with conventional vaginal hysterectomy. | Procedure or surgery | vNOTES Hysterectomy |
| Vaginal HysterectomyConventional vaginal hysterectomy performed for benign gynecologic indications using the standard vaginal surgical approach. | Procedure or surgery | Vaginal Hysterectomy |
Primary outcome
Postoperative pain score
Time frame: 24 hours after surgery
Postoperative pain will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
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 29 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Fatma KORUK, PhD study director
Harran University Faculty of Health Sciences
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 Vaginal Hysterectomy in people with Hysterectomy, Benign Uterine Diseases, run by Hatice Nur ÖZGEN at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 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 29 Sep 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 Hatice N ÖZGEN, PhD (+90-505-494-40-88, haticenurozgen@harran.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain score (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.