Comparison Between Robotic (RM) and Laparoscopic Myomectomy (LM)
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|ClinicalTrials.gov Identifier: NCT04282863|
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Uterine Leiomyoma Surgical Procedure, Unspecified||Procedure: RM Procedure: LM||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||494 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|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|
Active Comparator: robotic-assisted laparoscopic myomectomy (RM)
After randomization, participants who are assigned to the robotic-assisted laparoscopic myomectomy (RM) agree to receive 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.
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
- Conversion rate [ Time Frame: The surgical 1 day ]To compare the conversion rate between RM and LM
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282863
|Contact: Hung-Chang Lai, M.D/Ph. D.||+886-2-2249-0088 ext firstname.lastname@example.org|
|Contact: Kuo-Chang Wen, M.D/Ph. D.||+email@example.com|
|Taipei Medical University Shuang Ho Hospital|
|Taipei, Taiwan, +886|
|Contact: Hung-Chang Lai, M.D/Ph. D. +886-2-2249-0088 ext 8846 firstname.lastname@example.org|
|Principal Investigator: Hung-Chang Lai, M.D./Ph. D.|
|Principal Investigator:||Hung-Chang Lai, M.D/Ph. D.||Study Principal Investigator|