Uterine FibroidNCT06244251
Comparison Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids
A study testing TU-LESS and MPLS in people with Uterine Fibroid and Uterine Sarcoma, run by West China Second University Hospital at 1 site in China.
Trial summary
Myomectomy was preferably applied in females with reproductive requirements, which could be achieved by transumbilical laparoendoscopic single-site surgery (TU-LESS) or multi-port laparoscopic surgery (MPLS). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Uterine Fibroid, Uterine Sarcoma, Uterine Leiomyosarcoma
- What is being tested?
- TU-LESS and MPLS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosed with uterine fibroids before surgery on the basis of radiological or other examinations
- will consider TU-LESS or MPLS for myomectomy
Who cannot join
- patients reluctant to long-term follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Operational Outcomes and Long-term Benefits Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids
Myomectomy was preferably applied in females with reproductive requirements, which could be achieved by transumbilical laparoendoscopic single-site surgery (TU-LESS) or multi-port laparoscopic surgery (MPLS). Power morcellation used in MPLS was correlated with unidentified risk of tumor dissemination, especially in cases with accidental surgical findings of uterine sarcoma or leiomyosarcoma. Moreover, TU-LESS was reported to exceed MPLS in fast recovery. Therefore, the aim of this prospective cohort study is to compare the effectiveness of fast recovery and relative risk of tumor dissemination between TU-LESS and MPLS in myomectomy for the treatment of uterine fibroids.
- Conditions
- Uterine Fibroid, Uterine Sarcoma, Uterine Leiomyosarcoma
- Being tested
- TU-LESS, MPLS
- Keywords
- Uterine fibroids, TU-LESS, Multi-port laparoscopic surgery
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TU-LESSProcedure or surgery
TU-LESS group will receive TU-LESS for myomectomy; MPLS group will receive MPLS for myomectomy
MPLSProcedure or surgery
Patients with uterine who plan to receive MPLS for myomectomy
| Study group | Role | What they receive |
|---|---|---|
| TU-LESS for myomectomy | Experimental | Patients complaint of symptoms resulting from uterine fibroids, such as abnormal vaginal bleeding, frequent micturition, lower abdominal pain, constipation, etc or patients with uterine fibroids which were identified accidentally during routine body examination who consulted at our center for surgical removal of the fibroids. In the meantime, the diagnosis of uterine fibroids should be reconfirmed by at least one radiological examination at our center. The patients in the experiment group were those who received transumbilical laparoendoscopic single site surgery (TU-LESS) for myomectomy. Receives: Procedure: TU-LESS |
| MPLS for myomectomy | Active comparator | Patients complaint of symptoms resulting from uterine fibroids, such as abnormal vaginal bleeding, frequent micturition, lower abdominal pain, constipation, etc or patients with uterine fibroids which were identified accidentally during routine body examination who consulted at our center for surgical removal of the fibroids. In the meantime, the diagnosis of uterine fibroids should be reconfirmed by at least one radiological examination at our center. The patients in the experiment group were those who received multiport laparoscopic surgery (MPLS) for myomectomy. Receives: Procedure: MPLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospital stay after surgery
The number of days between myomectomy and the day of hospital discharge.
Measured: From enrollment to 1 month after receiving myomectomy
Secondary outcomes (7)
VAS score at 4, 8, 12, 16, 20, 24 hours after myomectomy
The visual analogue score at 4, 8, 12, 16, 20, 24 hours after myomectomy will be collected through questionnaire.
Measured: From enrollment to 24 hours after myomectomy
Time between myomectomy and exhaustion
The exact time between myomectomy and exhaustion will be collected during wards round by directly asking the patients.
Measured: From enrollment to 1 week after myomectomy.
Time of surgery
The time of surgery (from superficial incision to the end of umbilical suturing in experimental group and end of incision suturing in control group) will be collected during surgery.
Measured: From enrollment to 1 day after myomectomy.
Volume of bleeding during myomectomy
The exact volume of bleeding during myomectomy in both experimental and control group will be collected during surgery.
Measured: From enrollment to 1 day after myomectomy.
Number of uterine fibroids resected during surgery.
The exact number of uterine fibroids resected during myomectomy in both experimental and control group will be collected during surgery.
Measured: From enrollment to 1 day after myomectomy.
Pregnancy outcome
Whether the patient had pregnancy within 2 years after myomectomy. The information will be collected through online questionnaire and telephone.
Measured: From enrollment to 2 years after myomectomy
Occurrence of pelvic and abdominal metastasis after myomectomy in cases with accidental uterine malignancy
According to epidemiology data, a fraction of patients with primarily identified uterine fibroids will be pathologically diagnosed with uterine malignancy like uterine sarcoma after surgery. Whether the patients who were finally diagnosed with uterine malignancy based pathology developed abdominal or pelvic metastasis will be collected by telephone follow-up.
Measured: From enrollment to 2 years after receiving myomectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start24 Jun 2023
- Primary completion24 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Uterine FibroidStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Ying, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244251
- Sponsor's protocol ID
- 2023YFS0046
- Status last verified
- Jan 2024
- First submitted
- 9 Aug 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share the study protocol after its publication
Publications
Wright JD, Tergas AI, Burke WM, Cui RR, Ananth CV, Chen L, Hershman DL. Uterine pathology in women undergoing minimally invasive hysterectomy using morcellation. JAMA. 2014 Sep 24;312(12):1253-5. doi: 10.1001/jama.2014.9005. No abstract available.
PubMed 25051495Yuan P, Shan L, Yang X, Yu F, Ge Z, Wang M, Tan H. The merging of dual umbilical port-incisions for contained morcellation in laparoscopic myomectomy. Am J Obstet Gynecol. 2023 Jul;229(1):72-74. doi: 10.1016/j.ajog.2023.03.018. Epub 2023 Mar 17.
PubMed 36933684Glaser LM, Friedman J, Tsai S, Chaudhari A, Milad M. Laparoscopic myomectomy and morcellation: A review of techniques, outcomes, and practice guidelines. Best Pract Res Clin Obstet Gynaecol. 2018 Jan;46:99-112. doi: 10.1016/j.bpobgyn.2017.09.012. Epub 2017 Sep 29.
PubMed 29078975Wang L, Deng JY, Li KP, Zhu PY. A systematic review and meta-analysis comparing robotic single-site versus multi-port myomectomy. J Robot Surg. 2023 Aug;17(4):1319-1328. doi: 10.1007/s11701-023-01597-9. Epub 2023 Apr 24.
PubMed 37093509
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Operational Outcomes and Long-term Benefits Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids
- ClinicalTrials.gov ID
- NCT06244251
- Acronym / sponsor ID
- 2023YFS0046
- Conditions
- Uterine Fibroid, Uterine Sarcoma, Uterine Leiomyosarcoma
- Keywords
- Uterine fibroids, TU-LESS, Multi-port laparoscopic surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- West China Second University HospitalUniversity, hospital or other
- Study start
- 24 Jun 2023 (actual)
- Primary completion
- 24 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Feb 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.
Myomectomy was preferably applied in females with reproductive requirements, which could be achieved by transumbilical laparoendoscopic single-site surgery (TU-LESS) or multi-port laparoscopic surgery (MPLS). Power morcellation used in MPLS was correlated with unidentified risk of tumor dissemination, especially in cases with accidental surgical findings of uterine sarcoma or leiomyosarcoma. Moreover, TU-LESS was reported to exceed MPLS in fast recovery. Therefore, the aim of this prospective cohort study is to compare the effectiveness of fast recovery and relative risk of tumor dissemination between TU-LESS and MPLS in myomectomy for the treatment of uterine fibroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TU-LESS for myomectomy | Experimental | Procedure: TU-LESSPatients complaint of symptoms resulting from uterine fibroids, such as abnormal vaginal bleeding, frequent micturition, lower abdominal pain, constipation, etc or patients with uterine fibroids which were identified accidentally during routine body examination who consulted at our center for surgical removal of the fibroids. In the meantime, the diagnosis of uterine fibroids should be reconfirmed by at least one radiological examination at our center. The patients in the experiment group were those who received transumbilical laparoendoscopic single site surgery (TU-LESS) for myomectomy. |
| MPLS for myomectomy | Active comparator | Procedure: MPLSPatients complaint of symptoms resulting from uterine fibroids, such as abnormal vaginal bleeding, frequent micturition, lower abdominal pain, constipation, etc or patients with uterine fibroids which were identified accidentally during routine body examination who consulted at our center for surgical removal of the fibroids. In the meantime, the diagnosis of uterine fibroids should be reconfirmed by at least one radiological examination at our center. The patients in the experiment group were those who received multiport laparoscopic surgery (MPLS) for myomectomy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed with uterine fibroids before surgery on the basis of radiological or other examinations
- will consider TU-LESS or MPLS for myomectomy
Key exclusion criteria (1 listed)
- patients reluctant to long-term follow-up
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-LESSTU-LESS group will receive TU-LESS for myomectomy; MPLS group will receive MPLS for myomectomy | Procedure or surgery | TU-LESS for myomectomy |
| MPLSPatients with uterine who plan to receive MPLS for myomectomy | Procedure or surgery | MPLS for myomectomy |
Primary outcome
Duration of hospital stay after surgery
Time frame: From enrollment to 1 month after receiving myomectomy
The number of days between myomectomy and the day of hospital discharge.
7 secondary outcomes
VAS score at 4, 8, 12, 16, 20, 24 hours after myomectomy
Time frame: From enrollment to 24 hours after myomectomy
Time between myomectomy and exhaustion
Time frame: From enrollment to 1 week after myomectomy.
Time of surgery
Time frame: From enrollment to 1 day after myomectomy.
Volume of bleeding during myomectomy
Time frame: From enrollment to 1 day after myomectomy.
Number of uterine fibroids resected during surgery.
Time frame: From enrollment to 1 day after myomectomy.
Pregnancy outcome
Time frame: From enrollment to 2 years after myomectomy
Occurrence of pelvic and abdominal metastasis after myomectomy in cases with accidental uterine malignancy
Time frame: From enrollment to 2 years after receiving myomectomy
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 6 Feb 2024.
- Results publication: PubMed 25051495Wright JD, Tergas AI, Burke WM, Cui RR, Ananth CV, Chen L, Hershman DL. Uterine pathology in women undergoing minimally invasive hysterectomy using morcellation. JAMA. 2014 Sep 24;312(12):1253-5. doi: 10.1001/jama.2014.9005. No abstract available.
- Results publication: PubMed 36933684Yuan P, Shan L, Yang X, Yu F, Ge Z, Wang M, Tan H. The merging of dual umbilical port-incisions for contained morcellation in laparoscopic myomectomy. Am J Obstet Gynecol. 2023 Jul;229(1):72-74. doi: 10.1016/j.ajog.2023.03.018. Epub 2023 Mar 17.
- Results publication: PubMed 29078975Glaser LM, Friedman J, Tsai S, Chaudhari A, Milad M. Laparoscopic myomectomy and morcellation: A review of techniques, outcomes, and practice guidelines. Best Pract Res Clin Obstet Gynaecol. 2018 Jan;46:99-112. doi: 10.1016/j.bpobgyn.2017.09.012. Epub 2017 Sep 29.
- Results publication: PubMed 37093509Wang L, Deng JY, Li KP, Zhu PY. A systematic review and meta-analysis comparing robotic single-site versus multi-port myomectomy. J Robot Surg. 2023 Aug;17(4):1319-1328. doi: 10.1007/s11701-023-01597-9. Epub 2023 Apr 24.
- Individual participant dataSharing planned: Undecided. We will share the study protocol after its publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 MPLS in people with Uterine Fibroid and Uterine Sarcoma, 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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2024. 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?
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?
Duration of hospital stay after surgery (time frame: From enrollment to 1 month after receiving myomectomy). 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 NCT06244251, which also lists 4 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 6 Feb 2024.