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

Taipei Medical University

Status: Unknown

Conditions: Uterine Leiomyoma; Surgical Procedure, Unspecified

Treatments: Procedure: LM; Procedure: RM

Study type: Interventional

Funder types: Other

Identifiers

NCT04282863

ASGRS-TW001(RM:LM)

Details and patient eligibility

About

This is a single-blinded RCT evaluating the effect of robotic-assisted (RM) or conventional laparoscopic surgery (LM) in the management of uterine leiomyomas.

Full 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.

Enrollment: 494 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All women who has symptomatic benign myoma.

Exclusion criteria

• Patient is unwilling the scheduled operation after randomization.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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494 participants in 2 patient groups, including a placebo group

robotic-assisted laparoscopic myomectomy (RM)

Active Comparator group

Description:

After randomization, participants who are assigned to the robotic-assisted laparoscopic myomectomy (RM) agree to receive RM.

Treatment:

Procedure: RM

Conventional laparoscopic myomectomy (LM)

Placebo Comparator group

Description:

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

Treatment:

Procedure: LM