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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04282863
Enrollment
494
Registered
2020-02-25
Start date
2020-03-01
Completion date
2024-02-28
Last updated
2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Procedure, Unspecified, Uterine Leiomyoma

Keywords

Uterine Leiomyoma, robot-assisted (RM), conventional lapatoscopic myomectomy (LM)

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.

Interventions

PROCEDURERM

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.

PROCEDURELM

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.

Sponsors

Tri-Service General Hospital
CollaboratorOTHER
Taipei Medical University WanFang Hospital
CollaboratorOTHER
Asian Society for Gynecologic Robotic Surgery (ASGRS)
CollaboratorUNKNOWN
Taipei Medical University Shuang Ho Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

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.

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All women who has symptomatic benign myoma.

Exclusion criteria

* Patient is unwilling the scheduled operation after randomization.

Design outcomes

Primary

MeasureTime frameDescription
Conversion rateThe surgical 1 dayTo compare the conversion rate between RM and LM

Secondary

MeasureTime frameDescription
The amount of blood loss and transfusionThrough hospitalization duration, an average of 1 week
The dosage of antipyreticThrough hospitalization duration, an average of 1 week
The time of surgeryThe surgical 1 day
Readmission rateWithin 1 month after discharge
Myoma scoreThrough study completion, an average of 2 yearsThe score of myoma characteristics
The stay length of hospitalizationThrough hospitalization duration, an average of 1 week

Countries

Taiwan

Contacts

Primary ContactHung-Chang Lai, M.D/Ph. D.
hclai30656@gmail.com+886-2-2249-0088
Backup ContactKuo-Chang Wen, M.D/Ph. D.
19345@s.tmu.edu.tw+886-2-2249-0088

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026