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

January 28, 2024 updated by: Zheng Ying, West China Second University Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

5000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Second University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: TU-LESS
TU-LESS group will receive TU-LESS for myomectomy; MPLS group will receive MPLS for myomectomy
Active Comparator: 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.
Procedure: MPLS
Patients with uterine who plan to receive MPLS for myomectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to 1 month after receiving myomectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS score at 4, 8, 12, 16, 20, 24 hours after myomectomy
Time Frame: From enrollment to 24 hours after myomectomy
The visual analogue score at 4, 8, 12, 16, 20, 24 hours after myomectomy will be collected through questionnaire.
From enrollment to 24 hours after myomectomy
Time between myomectomy and exhaustion
Time Frame: From enrollment to 1 week after myomectomy.
The exact time between myomectomy and exhaustion will be collected during wards round by directly asking the patients.
From enrollment to 1 week after myomectomy.
Time of surgery
Time Frame: From enrollment to 1 day after myomectomy.
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.
From enrollment to 1 day after myomectomy.
Volume of bleeding during myomectomy
Time Frame: From enrollment to 1 day after myomectomy.
The exact volume of bleeding during myomectomy in both experimental and control group will be collected during surgery.
From enrollment to 1 day after myomectomy.
Number of uterine fibroids resected during surgery.
Time Frame: From enrollment to 1 day after myomectomy.
The exact number of uterine fibroids resected during myomectomy in both experimental and control group will be collected during surgery.
From enrollment to 1 day after myomectomy.
Pregnancy outcome
Time Frame: From enrollment to 2 years after myomectomy
Whether the patient had pregnancy within 2 years after myomectomy. The information will be collected through online questionnaire and telephone.
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
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.
From enrollment to 2 years after receiving myomectomy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective evaluation of incision healing
Time Frame: From enrollment to 3 months after myomectomy.
The patients will be asked to give rating of the recovery of surgical incision from 1 (the most unsatisfied) to 10 (the most satisfied) through questionnaire and telephone follow up.
From enrollment to 3 months after myomectomy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Second University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2023

Primary Completion (Estimated)

August 24, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

January 28, 2024

First Posted (Estimated)

February 6, 2024

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

January 28, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023YFS0046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We will share the study protocol after its publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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