Enlarged UterusNCT06663553
Comparing the Efficacy of TU-LESS and vNOTES for Hysterectomy of Enlarged Uterus
A study testing TU-LESS and vNOTES in people with Enlarged Uterus and Adenomyosis, run by West China Second University Hospital at 1 site in China.
Trial summary
Enlarged uterus is frequently encountered in clinical practice, and its incidence due to conditions such as adenomyosis, uterine fibroids, and other gynecological disorders has steadily increased over the years statistically. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Enlarged Uterus, Adenomyosis, Uterine Fibroids (UF)
- What is being tested?
- TU-LESS and vNOTES
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to Oct 2028
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible women aged 18-70 years.
- Women with indications for enlarged uterine volumes who are planning to under go total hysterectomy. Uterine size should exceed that of a 3-month pregnancy (uterine weight ≥ 280 g).
- Patients are willing to be randomly assigned to undergo any of both approaches.
- Patients who are willing to sign the informed consent form.
Who cannot join
- Individuals who are virgins or have vaginal stenosis.
- Patients requiring concurrent surgical intervention for conditions such as ovarian cysts or lesions of the vulva, vagina, appendix, etc.
- presence of uterus exceeding approximately 20 gestational weeks in size (about 900-1000g), which is beyond the limitations of a single-site laparoscopic approach due to concerns regarding technical feasibility and safety
- Presence of malignancy or strong suspicion of malignancy that may alter the planned surgical approach.
- History of two or more pelvic surgeries or suspected severe pelvic adhesions (rectovaginal examination suggesting rectovaginal endometriosis or limited uterine mobility).
- History of peritoneal dialysis, pelvic radiation therapy and pelvic tuberculosis treated with laparoscopic surgery.
Show all 9Show fewer
- Patients with prolapse or pelvic inflammation.
- Diabetes mellitus with poor blood glucose control.
- Body mass index greater than 30 kg/m².
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China Second University Hospital
Chengdu, Sichuan, 610041
Hongyu Jin, MD, 02885244323, jinhongyu324@icloud.com
About this study
Official title: Protocol for a Comparative Study of the Efficacy of Transumbilical Laparoendoscopic Single-site Surgery (TU-LESS) and Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) in Hysterectomy Performed on Patients With Enlarged Uterus: A Prospective Single-blinded, Randomized Clinical Trial
Enlarged uterus is frequently encountered in clinical practice, and its incidence due to conditions such as adenomyosis, uterine fibroids, and other gynecological disorders has steadily increased over the years statistically. For example, greater healthcare awareness has led to more frequent early diagnoses of these conditions, contributing to the observed rise in incidence. Additionally, increasing life expectancy results in more women reaching the perimenopausal and postmenopausal stages, during which conditions like uterine fibroids and adenomyosis become more prevalent. For these women, hysterectomy (removal of the entire uterus) is often the recommended option of treatment.
With advances in surgical techniques over recent decades, there has been a notable shift from traditional open abdominal surgeries to minimally invasive approaches. Laparoscopic surgery has been widely adopted, significantly reducing the size and number of incisions required, thereby promoting faster recovery, minimizing postoperative pain, and reducing the risk of complications.
Read more
However, conventional multi-port laparoscopic hysterectomy still presents certain challenges, such as large uterus extraction following resection, and concerns about healing of incisions. In contrast, innovative techniques like Transumbilical Laparoendoscopic Single-Site Surgery(TU-LESS) and Transvaginal Natural Orifice Transluminal Endoscopic Surgery(vNOTES) both take advantage of natural anatomical openings to achieve minimal or no visible scarring. Studies demonstrate that these techniques provide superior outcomes in terms of reduced pain, faster recovery, and quicker return to daily activities compared to traditional multi-port laparoscopic approaches.
Yet a direct comparison of the efficacy of these two methods in real-world, particularly for enlarged uterus, remains inconclusive. Thus this study aims to evaluate and compare the outcomes of these two techniques in patients with enlarged uteri. Participants will be randomly assigned to receive one of the two surgical approaches, ensuring an unbiased comparison of the efficacy of the procedures in terms of healing status and recovery time.
Read the detailed description
Enlarged uterus, mainly caused by adenomyosis, is often associated with symptoms like compression of intestines and urethra(presenting as constipation, urinary frequency, and urgency), dysmenorrhea, menstrual irregularity, and anemia due to menorrhagia. A hysterectomy (removal of the uterus) is often recommended, especially in cases where conservative management like medical treatment fails.
Among all the methods of hysterectomy, TU-LESS and vNOTES are noted for minimized invasiveness and fast recovery. As vNOTES is performed through the vagina and TU-LESS involves a single incision through the umbilicus, they both utilize natural anatomical openings, resulting in minimal to no visible scarring.
- Conditions
- Enlarged Uterus, Adenomyosis, Uterine Fibroids (UF)
- Being tested
- TU-LESS, vNOTES
- Medical subject headings
- Adenomyosis, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TU-LESSProcedure or surgery
patients in TU-LESS group will receive transumbilical laparoendoscopic single-site surgery (TU-LESS) for hysterectomy
vNOTESProcedure or surgery
patients in vNOTES group will receive transvaginal natural orifice transluminal endoscopic surgery (TU-LESS) for hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| TU-LESS for hysterectomy | Active comparator | Patients diagnosed with enlarged uteri following a bimanual examination, with confirmation of the size and nature of the enlargement through imaging techniques such as ultrasound or magnetic resonance imaging (MRI). Receives: Procedure: TU-LESS |
| vNOTES for hysterectomy | Experimental | Patients diagnosed with enlarged uteri following a bimanual examination, with confirmation of the size and nature of the enlargement through imaging techniques such as ultrasound or magnetic resonance imaging (MRI). Receives: Procedure: vNOTES |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative liquid diet
the proportion of patients able to consume a liquid diet post-surgery
Measured: within 24 hours postoperatively
passing flatus
the proportion of patients able to pass flatus
Measured: within 24 hours postoperatively
self-urination after catheter removal
The proportion of patients regaining the ability to urinate without assistance after catheter removal
Measured: within 24 hours postoperatively
ambulation
The proportion of patients regaining mobility after catheter removal
Measured: within 24 hours postoperatively
hospital stay
The percentage of patients discharged within 2 days after surgery
Measured: within 2 days postoperatively
examination of pelvic fuction
The assessment of pelvic floor function involves evaluating Stress Urinary Incontinence (SUI), Pelvic Organ Prolapse (POP) and Sexual Dysfunction.
The PISQ-IR (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) is a validated tool specifically designed to evaluate sexual function in the context of pelvic floor. It is a tool that measures sexual function specifically for women affected by pelvic floor disorders, such as urinary incontinence and pelvic organ prolapse.
Measured: within 2 days postoperatively
Secondary outcomes (7)
Postoperative pain
It is measured by the VAS score. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: at 12 hours and 24 hours postoperatively
The duration of operation
It will be measured in min utes, starting from the initiation of the skin (or vag inal) incision and concluding upon the completion of the skin (or vaginal) suturing. If a frozen biopsy is needed during the operation, the increased time for the frozen biopsy should be subtracted. However, pa tients for whom the surgical method is changed due to the result of the frozen biopsy should be excluded.
Measured: during operation
amount of bleeding
Measured: during operation
Intraoperative complications and postoperative complications
We use the Clavien-Dindo classification to rank a complication in an objective and reproducible manner.
It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study.
Measured: within 3 months
abdominal scars assessment
The Patient and Observer Scar Assessment Scale (POSAS) will be used. It consists of two separate scales: the Patient Scale and the Observer Scale and measures scar quality (i.e. how the scar looks and feels) from both perspectives.
The observer scores six items: vascularization, pigmentation, thickness, surface roughness, pliability, and surface area. The patient scores six items: pain, pruritus, color, thickness, relief, and pliability.
All included items are scored on the same polytomous 10-point scale, in which a score of 1 is given when the scar characteristic is akin to 'normal skin' and a score of 10 reflects the 'worst imaginable scar'. All items are summed to give a total scar score, and therefore, a higher score represents a poorer scar quality.
Measured: both at 3 and 6 months after surgery
the total dosage of analgesics taken
also categorized by analgesic type
Measured: during the first 24 hours following surgery
The Female Sexual Function Index(FSFI)
Using either a paper sheet or online questionnaire
Measured: both at baseline and 6 months 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 Oct 2024
- Study start1 Oct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2028 (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 Enlarged UterusStudies 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
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongyu Jin, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663553
- Sponsor's protocol ID
- 2020079JHY
- Status last verified
- Aug 2025
- First submitted
- 19 Oct 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Benassi L, Rossi T, Kaihura CT, Ricci L, Bedocchi L, Galanti B, Vadora E. Abdominal or vaginal hysterectomy for enlarged uteri: a randomized clinical trial. Am J Obstet Gynecol. 2002 Dec;187(6):1561-5. doi: 10.1067/mob.2002.127596.
PubMed 12501064Zhang W, Deng L, Yang F, Liu J, Chen S, You X, Gou J, Zi D, Li Y, Qi X, Wang Y, Zheng Y. Comparing the efficacy and safety of three surgical approaches for total hysterectomy (TSATH): protocol for a multicentre, single-blind, parallel-group, randomised controlled trial. BMJ Open. 2024 Jan 10;14(1):e074478. doi: 10.1136/bmjopen-2023-074478.
PubMed 38199630Chen X, Zhang M, Gao M, Wu Y, He Y, Liu J, Cui H, Jin H. Protocol for a study comparing the efficacy of hysterectomy in patients with enlarged uterus via TU-LESS and vNOTES: a single-blind, prospective randomised clinical trial. BMJ Open. 2025 Nov 26;15(11):e103174. doi: 10.1136/bmjopen-2025-103174.
PubMed 41298256
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Comparative Study of the Efficacy of Transumbilical Laparoendoscopic Single-site Surgery (TU-LESS) and Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) in Hysterectomy Performed on Patients With Enlarged Uterus: A Prospective Single-blinded, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06663553
- Acronym / sponsor ID
- 2020079JHY
- Conditions
- Enlarged Uterus, Adenomyosis, Uterine Fibroids (UF)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- West China Second University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 29 Oct 2024 (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.
Enlarged uterus is frequently encountered in clinical practice, and its incidence due to conditions such as adenomyosis, uterine fibroids, and other gynecological disorders has steadily increased over the years statistically. For example, greater healthcare awareness has led to more frequent early diagnoses of these conditions, contributing to the observed rise in incidence. Additionally, increasing life expectancy results in more women reaching the perimenopausal and postmenopausal stages, during which conditions like uterine fibroids and adenomyosis become more prevalent. For these women, hysterectomy (removal of the entire uterus) is often the recommended option of treatment.
With advances in surgical techniques over recent decades, there has been a notable shift from traditional open abdominal surgeries to minimally invasive approaches. Laparoscopic surgery has been widely adopted, significantly reducing the size and number of incisions required, thereby promoting faster recovery, minimizing postoperative pain, and reducing the risk of complications.
However, conventional multi-port laparoscopic hysterectomy still presents certain challenges, such as large uterus extraction following resection, and concerns about healing of incisions. In contrast, innovative techniques like Transumbilical Laparoendoscopic Single-Site Surgery(TU-LESS) and Transvaginal Natural Orifice Transluminal Endoscopic Surgery(vNOTES) both take advantage of natural anatomical openings to achieve minimal or no visible scarring. Studies demonstrate that these techniques provide superior outcomes in terms of reduced pain, faster recovery, and quicker return to daily activities compared to traditional multi-port laparoscopic approaches.
Yet a direct comparison of the efficacy of these two methods in real-world, particularly for enlarged uterus, remains inconclusive. Thus this study aims to evaluate and compare the outcomes of these two techniques in patients with enlarged uteri. Participants will be randomly assigned to receive one of the two surgical approaches, ensuring an unbiased comparison of the efficacy of the procedures in terms of healing status and recovery time.
Detailed description
Enlarged uterus, mainly caused by adenomyosis, is often associated with symptoms like compression of intestines and urethra(presenting as constipation, urinary frequency, and urgency), dysmenorrhea, menstrual irregularity, and anemia due to menorrhagia. A hysterectomy (removal of the uterus) is often recommended, especially in cases where conservative management like medical treatment fails.
Among all the methods of hysterectomy, TU-LESS and vNOTES are noted for minimized invasiveness and fast recovery. As vNOTES is performed through the vagina and TU-LESS involves a single incision through the umbilicus, they both utilize natural anatomical openings, resulting in minimal to no visible scarring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TU-LESS for hysterectomy | Active comparator | Procedure: TU-LESSPatients diagnosed with enlarged uteri following a bimanual examination, with confirmation of the size and nature of the enlargement through imaging techniques such as ultrasound or magnetic resonance imaging (MRI). |
| vNOTES for hysterectomy | Experimental | Procedure: vNOTESPatients diagnosed with enlarged uteri following a bimanual examination, with confirmation of the size and nature of the enlargement through imaging techniques such as ultrasound or magnetic resonance imaging (MRI). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eligible women aged 18-70 years.
- Women with indications for enlarged uterine volumes who are planning to under go total hysterectomy. Uterine size should exceed that of a 3-month pregnancy (uterine weight ≥ 280 g).
- Patients are willing to be randomly assigned to undergo any of both approaches.
- Patients who are willing to sign the informed consent form.
Key exclusion criteria (9 listed)
- Individuals who are virgins or have vaginal stenosis.
- Patients requiring concurrent surgical intervention for conditions such as ovarian cysts or lesions of the vulva, vagina, appendix, etc.
- presence of uterus exceeding approximately 20 gestational weeks in size (about 900-1000g), which is beyond the limitations of a single-site laparoscopic approach due to concerns regarding technical feasibility and safety
- Presence of malignancy or strong suspicion of malignancy that may alter the planned surgical approach.
- History of two or more pelvic surgeries or suspected severe pelvic adhesions (rectovaginal examination suggesting rectovaginal endometriosis or limited uterine mobility).
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 |
|---|---|---|
| TU-LESSpatients in TU-LESS group will receive transumbilical laparoendoscopic single-site surgery (TU-LESS) for hysterectomy | Procedure or surgery | TU-LESS for hysterectomy |
| vNOTESpatients in vNOTES group will receive transvaginal natural orifice transluminal endoscopic surgery (TU-LESS) for hysterectomy | Procedure or surgery | vNOTES for hysterectomy |
Primary outcome
postoperative liquid diet
Time frame: within 24 hours postoperatively
the proportion of patients able to consume a liquid diet post-surgery
passing flatus
Time frame: within 24 hours postoperatively
the proportion of patients able to pass flatus
self-urination after catheter removal
Time frame: within 24 hours postoperatively
The proportion of patients regaining the ability to urinate without assistance after catheter removal
ambulation
Time frame: within 24 hours postoperatively
The proportion of patients regaining mobility after catheter removal
hospital stay
Time frame: within 2 days postoperatively
The percentage of patients discharged within 2 days after surgery
examination of pelvic fuction
Time frame: within 2 days postoperatively
The assessment of pelvic floor function involves evaluating Stress Urinary Incontinence (SUI), Pelvic Organ Prolapse (POP) and Sexual Dysfunction. The PISQ-IR (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire) is a validated tool specifically designed to evaluate sexual function in the context of pelvic floor. It is a tool that measures sexual function specifically for women affected by pelvic floor disorders, such as urinary incontinence and pelvic organ prolapse.
7 secondary outcomes
Postoperative pain
Time frame: at 12 hours and 24 hours postoperatively
The duration of operation
Time frame: during operation
amount of bleeding
Time frame: during operation
Intraoperative complications and postoperative complications
Time frame: within 3 months
abdominal scars assessment
Time frame: both at 3 and 6 months after surgery
the total dosage of analgesics taken
Time frame: during the first 24 hours following surgery
The Female Sexual Function Index(FSFI)
Time frame: both at baseline and 6 months after surgery
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 18 Sep 2025.
- Results publication: PubMed 12501064Benassi L, Rossi T, Kaihura CT, Ricci L, Bedocchi L, Galanti B, Vadora E. Abdominal or vaginal hysterectomy for enlarged uteri: a randomized clinical trial. Am J Obstet Gynecol. 2002 Dec;187(6):1561-5. doi: 10.1067/mob.2002.127596.
- Results publication: PubMed 38199630Zhang W, Deng L, Yang F, Liu J, Chen S, You X, Gou J, Zi D, Li Y, Qi X, Wang Y, Zheng Y. Comparing the efficacy and safety of three surgical approaches for total hysterectomy (TSATH): protocol for a multicentre, single-blind, parallel-group, randomised controlled trial. BMJ Open. 2024 Jan 10;14(1):e074478. doi: 10.1136/bmjopen-2023-074478.
- Derived from this study: PubMed 41298256Chen X, Zhang M, Gao M, Wu Y, He Y, Liu J, Cui H, Jin H. Protocol for a study comparing the efficacy of hysterectomy in patients with enlarged uterus via TU-LESS and vNOTES: a single-blind, prospective randomised clinical trial. BMJ Open. 2025 Nov 26;15(11):e103174. doi: 10.1136/bmjopen-2025-103174.
- Individual participant dataSharing planned: Yes
Related trials for Enlarged Uterus
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
Active, not recruitingObservational study
Transvaginal Electromechanical Fragmentation and Removal of Large Uterus in a Sealed Bag: The First Group of Clinical Studies Balancing Scar - Free and Anti - Dissemination
Uterine Fibroids, Adenomyosis
Not yet recruiting
Myoma Screw in Manipulation of Large Uterus in Total Laparoscopic Hysterectomy
Total Laparoscopic Hysterectomy With Myoma Screw
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TU-LESS and vNOTES in people with Enlarged Uterus and Adenomyosis, run by West China Second University Hospital at 1 site in China.
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 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative liquid diet (time frame: within 24 hours postoperatively). The study lists 6 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 NCT06663553, 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 18 Sep 2025.