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Clinical Research on the Application of Single-channel Uterine Fibroid Morcellation System in Laparoscopic Myomectomy

NCT06442605 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-06-04

No results posted yet for this study

Summary

Research Purpose The purpose of this study is to explore whether the application of a single-channel uterine fibroid morcellation system compared to a multi-channel specimen retrieval bag during laparoscopic myomectomy can shorten the operative time and improve the efficiency of fibroid removal.

Research Design This study is a single-center, randomized, single-blind, 1:1 controlled trial.

Intervention Measures Study participants were randomly assigned in a 1:1 ratio into two groups.

Experimental group: Conventional laparoscopic myomectomy with the use of a single-channel uterine fibroid morcellation system for fragmentation and retrieval of the fibroids.

Control group: Conventional laparoscopic myomectomy with the use of a multi-channel specimen retrieval bag and a conventional laparoscopic uterine fibroid morcellator for fragmentation and retrieval of the fibroids.

Observation Indicators Primary observation indicator: Time required for fibroid fragmentation and retrieval (from the placement of the single-channel uterine fibroid morcellation system or the multi-channel specimen retrieval bag to complete removal from the abdominal cavity).

Secondary observation indicators: Success rate of placement, intraoperative damage and leakage rate, gynecological surgeon satisfaction with the surgery, total weight of retrieved uterine fibroid fragments.

Conditions

  • Leiomyoma, Uterine

Interventions

DEVICE

single-channel uterine fibroid morcellation system

Conventional laparoscopic myomectomy is performed with the use of a single-channel uterine fibroid morcellation system for fragmentation and retrieval of the fibroids during the procedure.

DEVICE

Multi-channel specimen retrieval bag + conventional laparoscopic uterine fibroid morcellator

In conventional laparoscopic myomectomy, a multi-channel specimen retrieval bag is used during the procedure, along with a conventional laparoscopic uterine fibroid morcellator for fragmentation and retrieval of the fibroids.

Sponsors & Collaborators

  • First People's Hospital of Hangzhou

    lead OTHER

Principal Investigators

  • Jinyi Tong · Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-20
Primary Completion
2025-06-19
Completion
2027-06-19

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06442605 on ClinicalTrials.gov