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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Procedure, Unspecified; Uterine Leiomyoma
• Intervention / Treatment: Procedure: RM; Procedure: LM

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.

• Study Type: Interventional
• Enrollment (Anticipated): 494
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hung-Chang Lai, M.D/Ph. D.; Phone Number: 8846 +886-2-2249-0088; Email: hclai30656@gmail.com
• Study Contact Backup: Name: Kuo-Chang Wen, M.D/Ph. D.; Phone Number: +886-2-2249-0088; Email: 19345@s.tmu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, +886
    • Taipei Medical University Shuang Ho Hospital
    • Contact: Hung-Chang Lai, M.D/Ph. D.; Phone Number: 8846 +886-2-2249-0088; Email: hclai30656@gmail.com
    • Principal Investigator: Hung-Chang Lai, M.D./Ph. D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All women who has symptomatic benign myoma.

Exclusion Criteria:

• Patient is unwilling the scheduled operation after randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Collaborators: Taipei Medical University WanFang Hospital; Tri-Service General Hospital; Asian Society for Gynecologic Robotic Surgery (ASGRS)
• Investigators: Principal Investigator: Hung-Chang Lai, M.D/Ph. D., Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): February 28, 2024

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Uterine Leiomyoma; robot-assisted (RM); conventional lapatoscopic myomectomy (LM)
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: ASGRS-TW001(RM:LM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No