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

NCT ID: NCT04282863

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 494 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2024-02-28

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.

Conditions

Uterine Leiomyoma; Surgical Procedure, Unspecified

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

robotic-assisted laparoscopic myomectomy (RM)

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

Group Type: ACTIVE_COMPARATOR

RM

Intervention Type: PROCEDURE

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.

Conventional laparoscopic myomectomy (LM)

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

Group Type: PLACEBO_COMPARATOR

LM

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Robotic-assisted laparoscopic myomectomy; Conventional laparoscopic myomectomy

Eligibility Criteria

Inclusion Criteria

• All women who has symptomatic benign myoma.

Exclusion Criteria

• Patient is unwilling the scheduled operation after randomization.

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tri-Service General Hospital

OTHER

Sponsor Role: collaborator

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role: collaborator

Asian Society for Gynecologic Robotic Surgery (ASGRS)

UNKNOWN

Sponsor Role: collaborator

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hung-Cheng Lai

Vice President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hung-Chang Lai, M.D/Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Taipei Medical University Shuang Ho Hospital

Taipei, , Taiwan

Countries

Taiwan

Central Contacts

Hung-Chang Lai, M.D/Ph. D.

Role: CONTACT

hclai30656@gmail.com

+886-2-2249-0088 ext. 8846

Kuo-Chang Wen, M.D/Ph. D.

Role: CONTACT

19345@s.tmu.edu.tw

+886-2-2249-0088

Facility Contacts

Hung-Chang Lai, M.D/Ph. D.

Role: primary

hclai30656@gmail.com

+886-2-2249-0088 ext. 8846

Other Identifiers

ASGRS-TW001(RM:LM)

Identifier Type: -

Identifier Source: org_study_id