Comparison Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids

NCT ID: NCT06244251

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

5000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-24

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Uterine Fibroid Uterine Sarcoma Uterine Leiomyosarcoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TU-LESS for myomectomy

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.

Group Type EXPERIMENTAL

TU-LESS

Intervention Type PROCEDURE

TU-LESS group will receive TU-LESS for myomectomy; MPLS group will receive MPLS for myomectomy

MPLS for myomectomy

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.

Group Type ACTIVE_COMPARATOR

MPLS

Intervention Type PROCEDURE

Patients with uterine who plan to receive MPLS for myomectomy

Interventions

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TU-LESS

TU-LESS group will receive TU-LESS for myomectomy; MPLS group will receive MPLS for myomectomy

Intervention Type PROCEDURE

MPLS

Patients with uterine who plan to receive MPLS for myomectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* diagnosed with uterine fibroids before surgery on the basis of radiological or other examinations
* will consider TU-LESS or MPLS for myomectomy

Exclusion Criteria

* patients reluctant to long-term follow-up
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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West China Second University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zheng Ying

Dean, Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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West China Second University Hospital

Chengdu, Sichuan, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 25051495 (View on PubMed)

Yuan 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.

Reference Type RESULT
PMID: 36933684 (View on PubMed)

Glaser 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.

Reference Type RESULT
PMID: 29078975 (View on PubMed)

Wang 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.

Reference Type RESULT
PMID: 37093509 (View on PubMed)

Other Identifiers

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2023YFS0046

Identifier Type: -

Identifier Source: org_study_id

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