Comparison Between Robotic (RM) and Laparoscopic Myomectomy (LM)
- Conditions
- Uterine LeiomyomaSurgical Procedure, Unspecified
- Interventions
- Procedure: RMProcedure: LM
- Registration Number
- NCT04282863
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 494
- All women who has symptomatic benign myoma.
- Patient is unwilling the scheduled operation after randomization.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description robotic-assisted laparoscopic myomectomy (RM) RM After randomization, participants who are assigned to the robotic-assisted laparoscopic myomectomy (RM) agree to receive RM. Conventional laparoscopic myomectomy (LM) LM After randomization, participants who are assigned to the Conventional laparoscopic myomectomy (LM) agree to receive LM.
- Primary Outcome Measures
Name Time Method Conversion rate The surgical 1 day To compare the conversion rate between RM and LM
- Secondary Outcome Measures
Name Time Method The time of surgery The surgical 1 day The stay length of hospitalization Through hospitalization duration, an average of 1 week The dosage of antipyretic Through hospitalization duration, an average of 1 week The amount of blood loss and transfusion Through hospitalization duration, an average of 1 week Readmission rate Within 1 month after discharge Myoma score Through study completion, an average of 2 years The score of myoma characteristics
Trial Locations
- Locations (1)
Taipei Medical University Shuang Ho Hospital
🇨🇳Taipei, Taiwan