Clinical trial NCT04282863: Comparison Between Robotic (RM) and Laparoscopic Myomectomy (LM)
Official title: Comparison Between Robotic (RM) and Laparoscopic Myomectomy (LM): a Multicenter Randomized Trial (RoLM Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Uterine Leiomyoma
Surgical Procedure, Unspecified
Keywords: Uterine Leiomyoma
robot-assisted (RM)
conventional lapatoscopic myomectomy (LM)
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
Collaborators: name: Tri-Service General Hospital
name: Taipei Medical University WanFang Hospital
name: Asian Society for Gynecologic Robotic Surgery (ASGRS)
First posted: 2020-02-25
Enrollment: 494
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* All women who has symptomatic benign myoma.

Exclusion Criteria:

* Patient is unwilling the scheduled operation after randomization.

Primary outcomes:
measure: Conversion rate
timeFrame: The surgical 1 day
Secondary outcomes:
measure: The time of surgery
timeFrame: The surgical 1 day
measure: The amount of blood loss and transfusion
timeFrame: Through hospitalization duration, an average of 1 week
measure: The dosage of antipyretic
timeFrame: Through hospitalization duration, an average of 1 week
measure: The stay length of hospitalization
timeFrame: Through hospitalization duration, an average of 1 week
measure: Readmission rate
timeFrame: Within 1 month after discharge
measure: Myoma score
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
Study officials:
affiliation: Study Principal Investigator
name: Hung-Chang Lai, M.D/Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: