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

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.

Condition or disease Intervention/treatment Phase
Uterine Leiomyoma Surgical Procedure, Unspecified Procedure: RM Procedure: LM Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 494 participants
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
Official Title: Comparison Between Robotic (RM) and Laparoscopic Myomectomy (LM): a Multicenter Randomized Trial (RoLM Trial)
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Fibroids

Arm Intervention/treatment
Active Comparator: robotic-assisted laparoscopic myomectomy (RM)
After randomization, participants who are assigned to the robotic-assisted laparoscopic myomectomy (RM) agree to receive RM.
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

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




Primary Outcome Measures :
  1. Conversion rate [ Time Frame: The surgical 1 day ]
    To compare the conversion rate between RM and LM


Secondary Outcome Measures :
  1. The time of surgery [ Time Frame: The surgical 1 day ]
  2. The amount of blood loss and transfusion [ Time Frame: Through hospitalization duration, an average of 1 week ]
  3. The dosage of antipyretic [ Time Frame: Through hospitalization duration, an average of 1 week ]
  4. The stay length of hospitalization [ Time Frame: Through hospitalization duration, an average of 1 week ]
  5. Readmission rate [ Time Frame: Within 1 month after discharge ]
  6. Myoma score [ Time Frame: Through study completion, an average of 2 years ]
    The score of myoma characteristics



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The women, age more than 20 y/o, have symptomatic benign myoma.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All women who has symptomatic benign myoma.

Exclusion Criteria:

  • Patient is unwilling the scheduled operation after randomization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282863


Contacts
Layout table for location contacts
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

Locations
Layout table for location information
Taiwan
Taipei Medical University Shuang Ho Hospital
Taipei, Taiwan, +886
Contact: Hung-Chang Lai, M.D/Ph. D.    +886-2-2249-0088 ext 8846    hclai30656@gmail.com   
Principal Investigator: Hung-Chang Lai, M.D./Ph. D.         
Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital
Tri-Service General Hospital
Taipei Medical University WanFang Hospital
Asian Society for Gynecologic Robotic Surgery (ASGRS)
Investigators
Layout table for investigator information
Principal Investigator: Hung-Chang Lai, M.D/Ph. D. Study Principal Investigator
Layout table for additonal information
Responsible Party: Hung-Cheng Lai, Vice President, Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier: NCT04282863    
Other Study ID Numbers: ASGRS-TW001(RM:LM)
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hung-Cheng Lai, Taipei Medical University Shuang Ho Hospital:
Uterine Leiomyoma
robot-assisted (RM)
conventional lapatoscopic myomectomy (LM)
Additional relevant MeSH terms:
Layout table for MeSH terms
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases