Uterine LeiomyomaNCT04282863
Comparison Between Robotic (RM) and Laparoscopic Myomectomy (LM)
A study testing RM and LM in people with Uterine Leiomyoma and Surgical Procedure, Unspecified, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Uterine Leiomyoma, Surgical Procedure, Unspecified
- What is being tested?
- RM and LM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 494 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2020to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All women who has symptomatic benign myoma.
Who cannot join
- Patient is unwilling the scheduled operation after randomization.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Medical University Shuang Ho Hospital
Taipei, +886
Hung-Chang Lai, M.D/Ph. D., +886-2-2249-0088 ext. 8846, hclai30656@gmail.com
Hung-Chang Lai, M.D./Ph. D.
About this study
Official title: 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.
Read the 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
- Being tested
- RM, LM
- Keywords
- Uterine Leiomyoma, robot-assisted (RM), conventional lapatoscopic myomectomy (LM)
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RMProcedure or surgery
Also called Robotic-assisted laparoscopic myomectomy
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.
LMProcedure or surgery
Also called Conventional laparoscopic myomectomy
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.
| Study group | Role | What they receive |
|---|---|---|
| robotic-assisted laparoscopic myomectomy (RM) | Active comparator | After randomization, participants who are assigned to the robotic-assisted laparoscopic myomectomy (RM) agree to receive RM. Receives: Procedure: RM |
| Conventional laparoscopic myomectomy (LM) | Placebo comparator | After randomization, participants who are assigned to the Conventional laparoscopic myomectomy (LM) agree to receive LM. Receives: Procedure: LM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate
To compare the conversion rate between RM and LM
Measured: The surgical 1 day
Secondary outcomes (6)
The time of surgery
Measured: The surgical 1 day
The amount of blood loss and transfusion
Measured: Through hospitalization duration, an average of 1 week
The dosage of antipyretic
Measured: Through hospitalization duration, an average of 1 week
The stay length of hospitalization
Measured: Through hospitalization duration, an average of 1 week
Readmission rate
Measured: Within 1 month after discharge
Myoma score
The score of myoma characteristics
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine LeiomyomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 494 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH), Taipei Medical University WanFang Hospital, Asian Society for Gynecologic Robotic Surgery (ASGRS)
- Responsible party
- Principal investigator, Hung-Cheng Lai, Taipei Medical University Shuang Ho Hospital
- Investigators
- Hung-Chang Lai, M.D/Ph. D., Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282863
- Sponsor's protocol ID
- ASGRS-TW001(RM:LM)
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Robotic (RM) and Laparoscopic Myomectomy (LM): a Multicenter Randomized Trial (RoLM Trial)
- ClinicalTrials.gov ID
- NCT04282863
- Acronym / sponsor ID
- ASGRS-TW001(RM:LM)
- Conditions
- Uterine Leiomyoma, Surgical Procedure, Unspecified
- Keywords
- Uterine Leiomyoma, robot-assisted (RM), conventional lapatoscopic myomectomy (LM)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 494 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH), Taipei Medical University WanFang Hospital, Asian Society for Gynecologic Robotic Surgery (ASGRS)
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robotic-assisted laparoscopic myomectomy (RM) | Active comparator | Procedure: RMAfter randomization, participants who are assigned to the robotic-assisted laparoscopic myomectomy (RM) agree to receive RM. |
| Conventional laparoscopic myomectomy (LM) | Placebo comparator | Procedure: LMAfter randomization, participants who are assigned to the Conventional laparoscopic myomectomy (LM) agree to receive LM. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All women who has symptomatic benign myoma.
Key exclusion criteria (1 listed)
- Patient is unwilling the scheduled operation after randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RMAlso: Robotic-assisted laparoscopic myomectomyAll 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. | Procedure or surgery | robotic-assisted laparoscopic myomectomy (RM) |
| LMAlso: Conventional laparoscopic myomectomyAll 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. | Procedure or surgery | Conventional laparoscopic myomectomy (LM) |
Primary outcome
Conversion rate
Time frame: The surgical 1 day
To compare the conversion rate between RM and LM
6 secondary outcomes
The time of surgery
Time frame: The surgical 1 day
The amount of blood loss and transfusion
Time frame: Through hospitalization duration, an average of 1 week
The dosage of antipyretic
Time frame: Through hospitalization duration, an average of 1 week
The stay length of hospitalization
Time frame: Through hospitalization duration, an average of 1 week
Readmission rate
Time frame: Within 1 month after discharge
Myoma score
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hung-Chang Lai, M.D/Ph. D. principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RM and LM in people with Uterine Leiomyoma and Surgical Procedure, Unspecified, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hung-Chang Lai, M.D/Ph. D. (+886-2-2249-0088 ext. 8846, hclai30656@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion rate (time frame: The surgical 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.