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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04282863
Other study ID # ASGRS-TW001(RM:LM)
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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