Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04282863
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Collaborators:
Tri-Service General Hospital
Taipei Medical University WanFang Hospital
Asian Society for Gynecologic Robotic Surgery (ASGRS)
Information provided by (Responsible Party):
Hung-Cheng Lai, Taipei Medical University Shuang Ho Hospital

Tracking Information
First Submitted Date  ICMJE February 7, 2020
First Posted Date  ICMJE February 25, 2020
Last Update Posted Date February 25, 2020
Estimated Study Start Date  ICMJE March 1, 2020
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2020)
Conversion rate [ Time Frame: The surgical 1 day ]
To compare the conversion rate between RM and LM
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2020)
  • The time of surgery [ Time Frame: The surgical 1 day ]
  • The amount of blood loss and transfusion [ Time Frame: Through hospitalization duration, an average of 1 week ]
  • The dosage of antipyretic [ Time Frame: Through hospitalization duration, an average of 1 week ]
  • The stay length of hospitalization [ Time Frame: Through hospitalization duration, an average of 1 week ]
  • Readmission rate [ Time Frame: Within 1 month after discharge ]
  • Myoma score [ Time Frame: Through study completion, an average of 2 years ]
    The score of myoma characteristics
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between Robotic (RM) and Laparoscopic Myomectomy (LM)
Official Title  ICMJE Comparison Between Robotic (RM) and Laparoscopic Myomectomy (LM): a Multicenter Randomized Trial (RoLM Trial)
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.
Detailed Description

Uterine fibroids are the most common benign tumors of the uterus and may be presented 20%-40% of women at reproductive age.The uterine fibroids can be asymptomatic without intervention. However, they often are the cause of abnormal uterine bleeding, pelvic pain, infertility, and even miscarriage. Myomectomy, rather than hysterectomy can be one option for symptomatic women who wish to preserve their childbearing capabilities or for reasons other than for fertilit. Nowadays, patients pursue cosmetic benefit and early recovery and prompted the search for more conservative and minimally invasive surgical methods when surgical intervention is inescapable and surgical devices are improved.

The feasibility, safety and advantage of cosmetics of laparoscopic myomectomy (LM) has been confirmed after the improvement of techniques and instruments. However, it is very "unfriendly" for our surgeons because of many disadvantages such as keeping stand for long time, unable to relying on, or swaying visual field by first-assistant, etc. Since the approval by the US Food and Drug Administration (FDA) in April 2005, robotic surgeries using the da Vinci Surgical System (Intuitive surgical Inc., Sunnyvale, CA, USA) have been applied widely in many surgical fields including gynecology, urology, orthopedics, general surgery and cardiothoracic surgery. The three-dimensional vision system and the wrist-like structure of EndoWrist instruments (Intuitive surgical Inc., Sunnyvale, CA, USA) recapitulating the motion of the surgeon's hand make precise procedures easier than in conventional laparoscopy, which allows robotic surgery to overcome some of the shortcomings and limitations of traditional laparoscopy. Dr. Lai and colleagues had also successfully undergone robotic surgery in many complicated gynecologic diseases in Taiwan.

However, how to choose or apply robotic-assisted (RM) or conventional laparoscopic surgery (LM) in the management of uterine leiomyomas is still an important issue for our surgeon. We still lack clear definitions about which one kind of myoma may be smoothly performed in RM or LM. The current study is aimed to compare the clinical outcome and efficacy of these 2 minimally invasive procedure in myomectomy, RM and LM, for women with symptomatic uterine fibroids, in this prospective randomised control trial.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE
  • Uterine Leiomyoma
  • Surgical Procedure, Unspecified
Intervention  ICMJE
  • 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.
    Other Name: Robotic-assisted laparoscopic 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.
    Other Name: Conventional laparoscopic myomectomy
Study Arms  ICMJE
  • Active Comparator: robotic-assisted laparoscopic myomectomy (RM)
    After randomization, participants who are assigned to the robotic-assisted laparoscopic myomectomy (RM) agree to receive RM.
    Intervention: Procedure: RM
  • Placebo Comparator: Conventional laparoscopic myomectomy (LM)
    After randomization, participants who are assigned to the Conventional laparoscopic myomectomy (LM) agree to receive LM.
    Intervention: Procedure: LM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 21, 2020)
494
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2024
Estimated Primary Completion Date February 28, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All women who has symptomatic benign myoma.

Exclusion Criteria:

  • Patient is unwilling the scheduled operation after randomization.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: The women, age more than 20 y/o, have symptomatic benign myoma.
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hung-Chang Lai, M.D/Ph. D. +886-2-2249-0088 ext 8846 hclai30656@gmail.com
Contact: Kuo-Chang Wen, M.D/Ph. D. +886-2-2249-0088 19345@s.tmu.edu.tw
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04282863
Other Study ID Numbers  ICMJE ASGRS-TW001(RM:LM)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hung-Cheng Lai, Taipei Medical University Shuang Ho Hospital
Study Sponsor  ICMJE Taipei Medical University Shuang Ho Hospital
Collaborators  ICMJE
  • Tri-Service General Hospital
  • Taipei Medical University WanFang Hospital
  • Asian Society for Gynecologic Robotic Surgery (ASGRS)
Investigators  ICMJE
Principal Investigator: Hung-Chang Lai, M.D/Ph. D. Study Principal Investigator
PRS Account Taipei Medical University Shuang Ho Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP