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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison Between Robotic (RM) and Laparoscopic Myomectomy (LM): a Multicenter Randomized Trial (RoLM Trial)

Conditions
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Uterine Leiomyoma, Surgical Procedure, Unspecified

Intervention / Treatment
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* Procedure: RM
* Procedure: LM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All women who has symptomatic benign myoma. Exclusion Criteria: Patient is unwilling the scheduled operation after randomization.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: robotic-assisted laparoscopic myomectomy (RM)<br>After randomization, participants who are assigned to the robotic-assisted laparoscopic myomectomy (RM) agree to receive RM. | Procedure: RM<br>* 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.<br>* Other names: Robotic-assisted laparoscopic myomectomy;|
| Placebo Comparator: Conventional laparoscopic myomectomy (LM)<br>After randomization, participants who are assigned to the Conventional laparoscopic myomectomy (LM) agree to receive LM. | Procedure: LM<br>* 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.<br>* Other names: Conventional laparoscopic myomectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conversion rate | To compare the conversion rate between RM and LM | The surgical 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time of surgery |  | The surgical 1 day | 
| The amount of blood loss and transfusion |  | Through hospitalization duration, an average of 1 week | 
| The dosage of antipyretic |  | Through hospitalization duration, an average of 1 week | 
| The stay length of hospitalization |  | Through hospitalization duration, an average of 1 week | 
| Readmission rate |  | Within 1 month after discharge | 
| Myoma score | The score of myoma characteristics | Through study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine Leiomyoma, robot-assisted (RM), conventional lapatoscopic myomectomy (LM)