Uterine myomas are the most commonly encountered benign tumors of the uterus, and myomectomy may be a therapeutic option. With advancements in surgical devices, the minimally invasive approach has become the primary choice. Robot-assisted gynecological surgery is being increasingly performed; however, there is controversy regarding the advantages of robotic myomectomy (RM) compared to those of conventional laparoscopic myomectomy (LM). We design a multiple-center observational cohort project to compare the performance of RM and LM.
In this project, participants will be stratified and assigned to the RM or LM group according to the suggestion of attending physicians’ and patients’ choices. We will recruit 222–444 patients, aged 20–80 years old, indicated for myomectomy.
The primary outcome will be the rate of conversion of RM and LM to laparotomy. The secondary outcome will include the intraoperative parameters, postoperative parameters, and duration of hospitalization. Additionally, we will attempt to generate a myoma score as the selection criteria for RM or LM.
This observational cohort project to compare RM and LM may provide stronger evidence regarding the advantages and disadvantages of robotic surgery for the most commonly encountered benign gynecological tumors.
Uterine myoma is the most common benign tumors of the uterus and may be presented 20–40% of women at reproductive age [
Because of small incision wound and cosmetics advantage, laparoscopic myomectomy (LM) has been confirmed in the management of uterine myoma [
A few case series comparing robotic hysterectomy with laparoscopic hysterectomy have been reported. Sarlos et al. [
The authors are accountable for all work aspects in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The Institutional Review Board of TMU approved this project (N202003111).
This trial will be conducted in the hospitals of the members of the Asian Society for Gynecologic Robotic Surgery (ASGRS), and the data will be archived at Shuang Ho Hospital, Taipei Medical University, Taiwan.
Patients will be screened for eligibility for the trial by surgeons. Women aged 20–80 years with symptomatic myoma will be eligible for this trial.
Patients will be excluded if they have a history of breast cancer, gynecological cancer, or cancer treatment; if they are pregnant, in the postpartum phase, or are breastfeeding; and if they present with abnormal Pap smear with atypical squamous cells of undertermined significance, atypical glandular cells, or worse.
We have invited members of the ASGRS to join this trial. Surgeons must be qualified for performing minimally invasive surgery in the field of gynecology. A record of performing independent laparoscopic surgeries for more than 3 years or performing robotic surgery for more than 24 patients within 1 year are minimal requirements. The case report form and related details for Institutional Review Board approval will be provided on request.
International Federation of Gynecology and Obstetrics (FIGO) classification of myoma will be included in our analysis. FIGO classification system for uterine myomas describes the relationship of myomas to the uterine wall [
However, FIGO myoma classification emphasizes the site of myoma but does not precisely reflect the complexity and surgical outcome of myomectomy. We intend to generate a new classification that can reflect surgical complexity for clinical guidance. In addition to FIGO classification, the size, number, and location of myoma by ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) will be included. The case report form of myoma is provided in
The primary endpoint is to compare the conversion rate (transfer to OM). Patients received to LM or RM but directly undergo OM without a laparoscopy or robot try due to technical difficulties will be included in the analysis. Those who directly go for OM for insurance concerns will be excluded in the final analysis. Secondary endpoints include treatment-related morbidity as evaluated by the incidence of: 1) intraoperative complications (injury to the bladder, ureters, bowel, blood vessels, and bleeding), 2) estimated blood loss and rate of blood transfusion, 3) re-admission within one month, and 4) days of hospitalization.
We also assess clinical parameters such as operation time, docking time, and console time. First, operation time is calculated from skin incision to skin closure. Docking time is then calculated from skin incision to all trocars connected with robotic arms. Lastly, console time is defined as the time from the surgeon finishing docking to finishing the robotic console performance.
Because there was no myoma score associated with the difficulty of operation, we generated a new myoma classification score predicting the risks of morbidities, including conversion rate, for future patient selection guidance. We also identified the quality factors of operation, such as operation time and blood loss, and includes the myoma characteristics such as the number, size, type, location, and FIGO type to create a multivariable myoma score model linear regression. When the surgeons key in the individual case’s myoma characteristic, the clinical outcomes will be predicted by the new myoma score model. The score is proportional to the operation’s difficulty and index to evaluate the appropriate approach for myomectomy.
Due to the limitations of national health insurance, it is not easy to randomize the participants to RM or LM. We will check the patient’s willingness to undergo minimally invasive surgery. If patients tend to undergo minimally invasive surgery, they cannot afford RM. They will be assigned to the LM group, even though the surgeon suggests OM. These cases will be documented and analyzed with the reference rate/distribution rate. Subjects will be labeled with a serial number (and therefore the name, name abbreviations, chart number, personal identification number, telephone number, fax number, mail address, and other information that lead to personal identification will not appear). The results will be stored and shared by all principal investigators.
In this trial, we aim to assess the difference of laparoscopic conversion rate between robotic surgery (P(Robotic)=1%) and laparoscopic surgery (P(Laparoscopy)=10%). In our experience, we performed over 100 cases of RM in past years, and there was no case to convert to OM. Since we imported the robotic platform in 2014, we found that the percentage of OM decreased, and RM increased gradually (
The 444 cases’ data were analyzed along with both the conversion rate and both group’s characteristics. All statistical analyses and debugging will use IBM SPSS Statistics for Windows, version 22.0 (IBM Corp., Armonk, NY, USA). Continuous variables are presented as median and interquartile, and categorical variables are presented as numbers (n) and percentages (%). The two-sample
We introduce the study design and flowchart to compare robotic and laparoscopic myomectomy. This observation cohort project is on the way and the results will be analyzed in future.
Since the FDA approved the robotic platform in the gynecological field in 2005, it has been a mature surgical technique for gynecological diseases. There is still an issue of learning curves in robotic surgery, although the platform is more user-friendly than laparoscopic surgery. Woelk et al. [
Myoma is heterogeneous in size, location, and FIGO type. These characteristics consist of complexity and directly influence the operation outcome. Thus, myomectomy surgery is individualized and difficult to standardize [
The initial trial was proposed for the collaborative effort of the ASGR members. Through this cooperation, ASGRS will strengthen the network and contribute to women’s health.
This work was supported by the Ministry of Science and Technology, Executive Yuan, Taiwan (MOST 109-2314-B-038-055-to KCW), Shuang Ho Hospital, Taipei Medical University (TMU108-AE1-B54 to KCW), and Teh-Tzer Study Group for Human Medical Research Foundation.
No potential conflict of interest relevant to this article was reported.
Flowchart of this trial. This trial will be performed in hospitals of the Asian Society for Gynecologic Robotic Surgery members as a flowchart. The inclusion and exclusion criteria are listed. ASCUS, atypical squamous cells of undetermined significance; AGUS, atypical glandular cells of undetermined significance. *Enrolled patients choose robotic or laparoscopic myomectomy according to their willing; the Institutional Review Board of TMU also approved this project.
Myoma score form. CT, computed tomography; MRI, magnetic resonance imaging; FIGO, International Federation of Gynecology and Obstetrics.
Myoma score for the example in
Myoma score for the example in
Sonography of uterine myoma and FIGO classification system. The case showed multiple myomas by ultrasound: (A) FIGO myoma calcification [
Computed tomography (CT) scan of uterine myoma and FIGO calcification. The case showed one huge myoma by ultrasound (A) and CT scan (B, C); FIGO myoma calcification [
The trend of myomectomy. The percentage of robotic myomectomy procedures performed gradually increased after we imported the robotic platform between 2013 till 2019 in Shuang Ho Hospital.