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Comparison Between Robotic (RM) and Laparoscopic Myomectomy (LM)

NCT04282863 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 494

Last updated 2020-02-25

No results posted yet for this study

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.

Conditions

  • Uterine Leiomyoma
  • Surgical Procedure, Unspecified

Interventions

PROCEDURE

RM

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.

PROCEDURE

LM

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.

Sponsors & Collaborators

  • Tri-Service General Hospital

    collaborator OTHER

  • Taipei Medical University WanFang Hospital

    collaborator OTHER

  • Asian Society for Gynecologic Robotic Surgery (ASGRS)

    collaborator UNKNOWN

  • Taipei Medical University Shuang Ho Hospital

    lead OTHER

Principal Investigators

  • Hung-Chang Lai, M.D/Ph. D. · Study Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2022-02-28
Completion
2024-02-28

Countries

  • Taiwan

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 NCT04282863 on ClinicalTrials.gov