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Active, Not Recruiting

NCT Number: NCT06244251

Comparison 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Uterine Fibroid Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Uterine Leiomyosarcoma Uterine Sarcoma

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

West China Second University Hospital

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TU-LESS

Procedure

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

MPLS

Procedure

Patients with uterine who plan to receive MPLS for myomectomy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

West China Second University Hospital

Other

Registry information

Official study title

Comparison of Operational Outcomes and Long-term Benefits Between Laparoendoscopic Single-site Surgery and Multi-port Laparoscopy in Treating Uterine Fibroids

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2024
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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