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

Surgical Procedure, Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04282863
• Other study ID #: ASGRS-TW001(RM:LM)
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: February 28, 2024

Study information

• Verified date: February 2020
• Source: Taipei Medical University Shuang Ho Hospital
• Contact: Hung-Chang Lai, M.D/Ph. D.
• Phone: +886-2-2249-0088
• Email: hclai30656[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 494
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• All women who has symptomatic benign myoma.

Exclusion Criteria:

• Patient is unwilling the scheduled operation after randomization.

Related Conditions & MeSH terms

• Leiomyoma
• Surgical Procedure, Unspecified
• Uterine Leiomyoma

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Shuang Ho Hospital	Taipei

Sponsors (4)

Lead Sponsor	Collaborator
Taipei Medical University Shuang Ho Hospital	Asian Society for Gynecologic Robotic Surgery (ASGRS), Taipei Medical University WanFang Hospital, Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion rate	To compare the conversion rate between RM and LM	The surgical 1 day
Secondary	The time of surgery		The surgical 1 day
Secondary	The amount of blood loss and transfusion		Through hospitalization duration, an average of 1 week
Secondary	The dosage of antipyretic		Through hospitalization duration, an average of 1 week
Secondary	The stay length of hospitalization		Through hospitalization duration, an average of 1 week
Secondary	Readmission rate		Within 1 month after discharge
Secondary	Myoma score	The score of myoma characteristics	Through study completion, an average of 2 years