NCT04282863

Brief Summary

This is a single-blinded RCT evaluating the effect of robotic-assisted (RM) or conventional laparoscopic surgery (LM) in the management of uterine leiomyomas.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
494

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 25, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

February 7, 2020

Last Update Submit

February 21, 2020

Conditions

Uterine LeiomyomaSurgical Procedure, Unspecified

Keywords

Uterine Leiomyomarobot-assisted (RM)conventional lapatoscopic myomectomy (LM)

Outcome Measures

Primary Outcomes (1)

  • Conversion rate

    To compare the conversion rate between RM and LM

    The surgical 1 day

Secondary Outcomes (6)

  • The time of surgery

    The surgical 1 day

  • The amount of blood loss and transfusion

    Through hospitalization duration, an average of 1 week

  • The dosage of antipyretic

    Through hospitalization duration, an average of 1 week

  • The stay length of hospitalization

    Through hospitalization duration, an average of 1 week

  • Readmission rate

    Within 1 month after discharge

  • +1 more secondary outcomes

Study Arms (2)

robotic-assisted laparoscopic myomectomy (RM)

ACTIVE COMPARATOR

After randomization, participants who are assigned to the robotic-assisted laparoscopic myomectomy (RM) agree to receive RM.

Procedure: RM

Conventional laparoscopic myomectomy (LM)

PLACEBO COMPARATOR

After randomization, participants who are assigned to the Conventional laparoscopic myomectomy (LM) agree to receive LM.

Procedure: LM

Interventions

RMPROCEDURE

All patients were positioned in a lithotomy position. A uterine manipulator and a Foley catheter were inserted. Four trocars were used after pneumoperitoneum was obtained. Trocar sites varied according to different procedures. Generally, umbilical site for the scope and 8-10 cm lateral to the scope at 15 degrees for the arms are the most commonly adopted sites for robotic myomectomy.

Also known as: Robotic-assisted laparoscopic myomectomy
robotic-assisted laparoscopic myomectomy (RM)
LMPROCEDURE

All patients were positioned in a lithotomy position. A uterine manipulator and a Foley catheter were inserted. Four trocars were used after pneumoperitoneum was obtained: a 10 mm port is inserted through the umbilicus to introduce the video-laparoscopic system. Other three accessory 5 mm trocar are inserted into the abdomen to the left lower quadrant, right lower quadrant, suprapubic area, for operative instruments and the suction irrigator cannula.

Also known as: Conventional laparoscopic myomectomy
Conventional laparoscopic myomectomy (LM)

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe women, age more than 20 y/o, have symptomatic benign myoma.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All women who has symptomatic benign myoma.

You may not qualify if:

  • Patient is unwilling the scheduled operation after randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University Shuang Ho Hospital

Taipei, +886, Taiwan

Location

MeSH Terms

Conditions

Myofibroma

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hung-Chang Lai, M.D/Ph. D.

    Study Principal Investigator

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Chang Lai, M.D/Ph. D.

CONTACT

+886-2-2249-0088hclai30656@gmail.com

Kuo-Chang Wen, M.D/Ph. D.

CONTACT

+886-2-2249-008819345@s.tmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This is a single-blinded RCT evaluating the effect of RM and LM in the management of uterine leiomyomas. Participants will be stratified on hospital performing the procedure and thereafter randomly assigned to the RM or LM group with allocation ratio 1:1.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 25, 2020

Study Start

March 1, 2020

Primary Completion

February 28, 2022

Study Completion

February 28, 2024

Last Updated

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)