Between January 2015 and September 2019, the medical records of women with uterine myoma managed by LETS-M at a tertiary referral center were retrospectively reviewed. This study received approval from the Research Ethics Committee of National Taiwan University Hospital (ID NO. 202001027RINA). Informed consent was obtained from all participants before surgeries. All methods in this study were performed in accordance with the relevant guidelines and regulations. Additionally, this study was registered on ClinicalTrials.gov (NCT04279626).
We included women who were older than 20 years old and had not reached menopause, with symptomatic uterine myomas, such as hypermenorrhea, infertility, and mass-effect-related urinary frequency and constipation. The exclusion criteria included dominant symptoms with active pelvic or urinary tract infection, a history of pelvic radiotherapy, a preexisting or suspicious malignant pelvic tumor, and pathologies other than uterine myoma noted during the operation. Informed consent for surgery and anesthesia was obtained from all patients.
The review of the chart records consisted of a detailed history, including age, body mass index (BMI), gravidity, parity, marital status, sexual experience, previous abdominal surgery, and hospital stay after the surgery. All women received preoperative ultrasound for their uterine myoma assessment, including the location, type, size, number, and accompanying pathology, such as an ovarian tumor. The myoma locations were identified during the operation and classified into fundal wall myoma, anterior wall myoma, posterior wall myoma and cervical myoma. The myoma type classification was based on the International Federation of Gynecology and Obstetrics (FIGO) leiomyoma subclassification system(29). We measured the weight of the specimen after finishing the surgery. The operation time was defined as the period from the incision to the closure of the skin and was the primary outcome of this study. Any intraoperative blood loss less than 50 mL or minimal blood loss on operation note was recorded as 50 mL in this study. Excessive blood loss was defined as blood loss of 500 mL or more during the operation. The postoperative pain scale was evaluated by a visual analog scale (VAS) on the first and second postoperative days.
Surgical Techniques for LETS-M
Under endotracheal general anesthesia, the patient was placed in the lithotomy position. After skin disinfection and sterile draping, the uterine manipulator and Foley catheter were inserted. A 1.5 cm skin incision was made over the umbilicus, and the abdominal wall was opened layer by layer with the open method. A wound retractor (Alexis, 2-4 cm; Applied Medical Resources Corp., Rancho Santa Margarita, CA) was placed, and the glove port was set up, with a 10-mm trocar in the thumb over the patient's right side and a 5-mm trocar in the little finger over the left side. The pneumoperitoneum was established. A 10-mm rigid laparoscope was inserted via the 10-mm trocar and controlled by the assistant. The ancillary 5-mm port was made over the left lower abdomen under laparoscope inspection. The surgeon performed the surgery via the two 5-mm trocars (Figure 2A).
After the uterine myoma was identified, we injected diluted vasopressin (20 IU/mL diluted in 100 mL saline) into the layer between the pseudocapsule of the myoma and the myometrium(30). A transverse incision with appropriate length was made on the uterine serosa of the most protruding part of the myoma (Figure 2B). The myoma was then enucleated with the aid of LigaSure (Valleylab, Boulder, CO) and a myoma screw. The operator had to continue dissecting and pulling out the myoma while being careful not to injure the adjacent ureter, bladder, or rectum. The base of the myoma should be clearly visualized to avoid any perforation of the endometrium if the myoma is close or attached to the endometrium on ultrasound. Any perforation of the endometrium was carefully sutured without avulsion. The uterine wound was sutured with 1-0 V-loc barbed sutures (Medtronic, Minneapolis, MN) continuously. We provide a novel method for needle delivery and removal in laparoscopic surgery (Figure 2C to 2H). The suture needle was inserted outside-in through the glove (Figure 2C) and grasped by the needle holder (held by the operator’s right hand) inside the glove (Figure 2D), and then the suture was delivered into the pelvis (Figure 2E). The uterine wound was sutured in 2 or more continuous layers (Figure 2F). After the uterine wound was repaired, the needle was removed by direct punching through the glove (Figure 2G, 2H). We irrigated the uterine wound and pelvis and then applied hemostatic agents, such as Tisseel (Baxter, Vienna, Austria) or Floseal (Baxter, Vienna, Austria), and anti-adhesive agents. The specimen was manually morcellated out via the umbilical wound with a scalpel (Figure 3A and 3B). Tissue glue, such as Dermabond (Ethicon, Somerville, NJ), was applied for skin approximation (Figure 3C) after the fascial layer was repaired with 2-0 Vicryl. Typical wound appearance at the 3rd postoperative month is shown in Figure 3D.
Twenty-one operations were performed by three trainees who were residents of the Department of Obstetrics and Gynecology at National Taiwan University Hospital. They were experienced in basic laparoscopic adnexal surgery but had no experience in laparoscopic suture skills. These 21 surgeries were performed under the supervision of the experienced surgeon (WC Chang).
Statistical Analysis
MedCalc Statistical Software version 18.10.2 (MedCalc Software bvba, Ostend, Belgium) was used for statistical analyses. For baseline comparisons, age at operation, gynecological characteristics, details of myoma, and surgical outcomes were statistically examined by Fisher’s exact test for categorical variables and the Mann-Whitney U test for continuous variables. Univariate and multivariable linear regression analyses were performed to preoperatively predict longer operation times. The Kruskal-Wallis test was applied for operation time comparison among different myoma locations. A p value less than .05 was considered statistically significant. The multivariable analysis was performed using variables that had a p value <.05 from the univariate analysis.
Data Availability Statement
The datasets analyzed during the current study are available from the corresponding author on reasonable request.