Application value of laparo-endoscopic single-site surgery during the second and third trimesters complicated with gynecological pelvic mass.

Between June 2018 and June 2023, medical records of patients undergoing surgery for GPMs in Union Hospital, Tongji Medical College, Huazhong University of Science and Technology and Shannan Maternal and Child Health Hospital, and Department of Gynaecology, Zhongnan Hospital of Wuhan University, were collected. All surgical procedures in one institution were performed by the same experienced minimally invasive surgeon (who had experience with at least 30 LESS surgery procedures). Patients enrolled were divided into the LESS surgery group, the CL surgery group and the TA surgery group. If minimally invasive surgery was estimated to be quite difficult to perform after the preoperative evaluation—for example, with patients who had a history of pelvic surgery or endometriosis—then LESS surgery could not be selected directly. A comparative study was consequently performed using perioperative data, followed by tracking the outcomes of both the mother and the infant for up to one year post-delivery. The inclusion criteria were as follows: (1) a gestational age between 12 and 40 weeks; (2) good general health status for the patient; (3) an absence of contraindications for laparoscopic surgery and general anesthesia; and (4) the patient had intact umbilical area skin without deformity. The exclusion criteria were as follows: (1) the patient had suspected malignant tumors (as determined by the presence of tumors as solid or cystic changes, a thickening of the cyst wall accompanied by endogenous papillae or nodules, abundant local blood flow and reduced blood flow resistance as indicated by Doppler ultrasound, a significant amount of free fluid in the chest and abdominal cavity, and so on) [ 13 ]; (2) threatened abortion; (3) a gestational week < 12 weeks; (4) the patient had combined gestational hypertension or diabetes; and (5) the presence of vital organ insufficiency. The patients’ clinical data were collected, including age, body mass index (BMI), gestational history, gestational week at the time of operation, preoperative hemoglobin level, mass size, and so on. The patients’ perioperative data were also collected, including the operation duration (defined as the time interval between skin incision and closure), the intraoperative blood CO 2 pressure, the time of first postoperative anal exhaustion, the time of postoperative bed rest, the pain score [the visual pain analogue score (VAS) was used, and this was measured at 24 h post-surgery], inflammation indicators [namely, C-reactive protein (CRP), the white blood cell count (WBC), the length of hospital stay following surgery, short-term postoperative complications within 72 h after the surgery (such as threatened abortion/preterm birth including contractions requiring medical intervention, fever lasting ≥ 3 days, urinary tract infection, intestinal obstruction, bladder or intestinal injury, and so on), long-term complications lasting no more than one year (for example, incisional hernias), and scar evaluation [assessed by the surgeon who performed the operation according to the Scar Cosmesis Assessment and Rating (SCAR) scale] [ 14 ]. In addition to the clinical data regarding the pregnant women, data on infants at one-year of age were also collected, including general growth and development indicators (such as head circumference, height, weight, and so on), neuromotor scores (using the 20-score neuromotor test designed for infants aged 0–1 years old) and neurodevelopmental scores (using a developmental behavior assessment scale designed for infants aged 0–6 years old). All procedures were performed by surgeons with experience of at least 30 LESS surgery cases, who were proficient in all three surgical approaches. They maintained an annual caseload of over 200 traditional open surgeries, ensuring consistency in surgical techniques across all groups. The patients were placed in the supine position, with the operating table tilted 10–15˚ to the left to prevent intrauterine distress caused by pressure on the inferior vena cava. A 2–2.5 cm incision was then made in the umbilical or epigastric region, and the pneumoperitoneum was established with a pressure of 10–12 mmHg and a flow rate of 5 l/min. All procedures followed strict fetal monitoring: at the preoperative stage, routine fetal heart monitoring and ultrasound evaluation was performed, and the biophysical profile was prepared for gestational age ≥ 24 weeks. At the intraoperative stage, continuous Doppler fetal heart monitoring was performed. At the postoperative stage, immediate fetal monitoring during recovery was performed. Hourly fetal heart checks were made during the first 24 h. In addition, uterine tocolytics were used prophylactically for 2–3 days (including oral progesterone; 1 tablet; q6-8 h) for those with high risk factors of miscarriage or premature delivery. All results were analyzed using SPSS 26.0 software (IBM Corp., Armonk, NY, USA). In terms of determining whether there were any statistically significant differences among the three surgical methods groups, the LESS surgery group was taken as the reference standard. Continuous data with normal distribution were expressed as the mean ± standard deviation or median (IQR), and Student’s t test was applied. Categorical variables were expressed as the frequency, number and percentage, and the Chi-square test was used. The normality of data was assessed using the Kolmogorov–Smirnov test. Since all three groups showed non-normal distributions (all P  < 0.05), the Kruskal–Wallis test was applied for group comparisons.

There were 16, 25 and 18 patients who underwent LESS surgery, CL surgery and TA surgery for second and third trimesters combined with GPMs, respectively. No statistically significant differences were identified in terms of age ( P  = 0.870), gravidity ( P  = 0.933), parity ( P  = 0.375), gestational week at surgery ( P  = 0.027) or among the three groups. The only significant increase noted was for the average mass diameter ( P  < 0.001), as shown in Table  1 . Table 1 Comparison of clinical characteristics among LESS, CL, and TA groups Indicator LESS Group n  = 16 CL Group n  = 25 TA Group n  = 18 F Value P Value Age (years) 29.00 ± 4.35 29.12 ± 5.10 29.78 ± 4.63 0.14 0.870 Gravidity 1.88 ± 0.96 1.92 ± 0.91 2.00 ± 1.14 0.07 0.933 Parity 0.19 ± 0.40 0.40 ± 0.50 0.33 ± 0.49 1.00 0.375 Gestational Week 16.06 ± 3.97 15.20 ± 2.06 16.83 ± 2.98 1.62 0.207 Average Mass Diameter/cm 10.88 ± 3.72 8.04 ± 3.56 15.06 ± 2.34 31.52  < 0.001 Comparison of clinical characteristics among LESS, CL, and TA groups All operations were completed as planned. Compared with the TA group, the laparoscopic groups (namely, LESS surgery and CL surgery) exhibited significantly shorter operative times ( P  = 0.033), first flatus time ( P  = 0.025), shorter bed rest time ( P  < 0.001), lower inflammatory indicators (CRP: P  < 0.001; and WBC: P  < 0.001) and shorter length of hospitalization ( P  < 0.001) after the operation. However, no significant statistical differences were noted between these indicators in the LESS surgery and CL surgery groups. The LESS surgery group was only noted to have a lower VAS pain score (0.56 ± 0.63 vs. 2.04 ± 0.68, P  < 0.001) and a lower SCAR score at 1 month following surgery (1.34 ± 0.63 vs. 2.32 ± 0.68, P  < 0.001) compared with the CL group, as shown in Table  2 . Table 2 Comparison of perioperative parameters among LESS, CL, and TA groups Indicator LESS Group n  = 16 CL Group n  = 25 TA Group n  = 18 F/  ×  2 P Value Time of Postoperative bed rest/h 20.19 ± 2.97 22.56 ± 2.86 37.33 ± 3.07 26.43  < 0.001 postoperative pain score/points 0.56 ± 0.63 2.04 ± 0.68 4.28 ± 0.75 9.23  < 0.001 Perioperative Inflammation Indicators CRP (mg/L) 7.49 ± 2.55 11.94 ± 4.51 15.06 ± 5.60 12.19  < 0.001 White Blood Cell Count (× 10 9 /L) 9.15 ± 2.49 9.14 ± 2.67 12.26 ± 1.77 10.75  < 0.001 Postoperative hospital stay/days 3.12 ± 1.28 3.82 ± 0.98 5.68 ± 0.75 10.59  < 0.001 Scarring Score at 1 month Postoperative/points 1.34 ± 0.63 2.32 ± 0.68 5.28 ± 0.75 79.99  < 0.001 Comparison of perioperative parameters among LESS, CL, and TA groups No complications, such as fever, intestinal obstruction or surgical incision infection, occurred in the laparoscopic groups. Irregular contractions requiring medical intervention did occur in one case (6.25%) in the LESS surgery group, and in two cases (8.0%) in the CL group. In the TA group, there was one case of fever (5.6%), one case of incision infection (5.6%), and three cases of irregular contractions (16.7%). The total incidence of complications in the three groups was 6.25% for the LESS surgery group, 8% for the CL group, and 27.9% for the TA group. The postoperative complication rate was found to be higher in the TA group compared with the other two groups (P = 0.037). No long-term complications occurred in any of the three groups, as shown in Table  2 . In the LESS surgery group, one case had a premature birth via vaginal delivery at 35 weeks due to the premature rupture of membranes. In the TA group, one case with a twin pregnancy underwent emergency cesarean section at 34 weeks of gestation due to severe pre-eclampsia. All the remaining patients were delivered at full-term time. In this dataset, since the Kolmogorov–Smirnov test yielded P -values < 0.05 for all three groups (indicating non-normal distribution), the Kruskal–Wallis non-parametric test was subsequently employed for analysis. No significant differences were observed in head circumference ( P  = 0.615; P  = 0.224), body length ( P  = 0.589; P  = 0.591) or body weight ( P  = 0.070; P  = 0.127) for the LESS surgery, CL surgery and TA surgery groups, respectively, at birth, and subsequently at one year of age. Neuromotor ( P  = 0.072) and neurodevelopmental ( P  = 0.735) scores were evaluated for the infants at one year of age, and no significant differences were noted among the three groups (Table  3 ). Table 3 Comparison of growth and neuro developmental indicators of deliveries among LESS, CL, and TA groups Group Child growth and development assessment Child Neuromotor Score Child neurodevelopmental score (1 Year) Head circumference (cm) Body length (cm) Body weight (kg) Gross Motor Skills Fine Motor Skills Adaptability Language Expression Social Skills Total Development Quotient At Birth 1 Year At Birth 1 Year At Birth 1 Year LESS 32.63 ± 0.89 45.00 ± 1.37 50.50 ± 0.97 73.31 ± 3.32 3.33 ± 0.24 11.00 ± 0.32 16.06 ± 0.85 106.75 ± 6.17 107.38 ± 6.24 108.19 ± 5.08 108.19 ± 5.00 108.5 ± 5.05 108.25 ± 5.64 CL 32.68 ± 0.75 45.56 ± 1.45 50.28 ± 1.02 73.16 ± 3.58 3.43 ± 0.34 11.00 ± 0.33 16.20 ± 0.76 107.44 ± 5.89 107.88 ± 5.93 109.12 ± 4.44 110.44 ± 2.84 110.36 ± 3.26 109.44 ± 5.24 TA 32.50 ± 0.79 45.50 ± 1.47 50.33 ± 1.03 73.22 ± 3.78 3.31 ± 0.29 10.97 ± 0.24 16.11 ± 0.96 108.72 ± 4.32 108.89 ± 4.92 108.56 ± 4.96 108.61 ± 4.93 108.06 ± 6.25 108.78 ± 5.94 F Value 5.17 3.92 2.24 1.01 4.67 3.18 2.53 5.57 3.32 1.99 2.72 1.48 1.53 P Value 0.615 0.224 0.589 0.591 0.070 0.127 0.072 0.571 0.071 0.822 0.206 0.086 0.735 Comparison of growth and neuro developmental indicators of deliveries among LESS, CL, and TA groups

In conclusion, the findings of the present study have demonstrated that, in appropriately selected cases, LESS surgery performed by experienced surgeons represents a safe and feasible alternative to CL surgery during pregnancy, and that is has distinct advantages in postoperative recovery and cosmetic outcomes. This study has contributed meaningful evidence to an under-investigated field by offering comprehensive technical descriptions and longitudinal outcome data. Nevertheless, the retrospective design and limited sample size highlight the necessity to perform larger, multicenter prospective studies to validate these results, and to inform evidence-based clinical guidelines for LESS surgery during pregnancy.

Laparoscopic surgery during pregnancy has been shown not to be associated with increased maternal–fetal risks compared with laparotomy, with comparable or lower complication rates reported [ 15 , 16 ]. As an innovative, minimally invasive technique, LESS surgery is increasingly being utilized in early-pregnancy gynecological procedures (such as ectopic pregnancy), and it has demonstrated no significant differences in outcomes compared with CL [ 17 ]. However, studies evaluating the safety and feasibility of surgical interventions for gynecological masses during pregnancy remain limited [ 18 , 19 ]. Therefore, the present study has provided detailed data from 16 cases of LESS surgery performed during the second and third trimesters, representing one of the larger sample sizes in this specialized field. Our findings are both consistent with, and have added to, the existing literature on LESS surgery during pregnancy. In the present study, regarding the operative times, no significant differences were observed between the LESS surgery and CL groups, a finding that is aligned with the meta-analysis performed by Schmitt et al. [ 20 ]: they reported operative times that were comparable between LESS surgery and the CL group for benign adnexal diseases. It is noteworthy that, as demonstrated by Xiao et al. [ 21 ], when performed by experienced surgeons (namely, those with experience of ≥ 30 procedures), this difference becomes negligible even for larger masses. In terms of fetal safety, our data have further confirmed the safety of minimally invasive techniques. No significant differences were observed in infant outcomes at one year of age among the three groups. This finding is strongly supported by the systematic review by Cagino et al. [ 22 ], which concluded that minimally invasive surgery for adnexal masses during pregnancy, especially in the second trimester, is safe. The present study has strengthened this evidence by providing one-year neurodevelopmental follow-up data, which is less commonly reported in the existing literature. Cosmetic outcome is a significant advantage of LESS surgery. Our study has confirmed that the LESS surgery group had significantly improved cosmetic scores compared with the CL group. This is a critical patient-reported outcome that is especially relevant for pregnant populations concerned about body image changes. Our results are consistent with the findings of Yin et al. [ 23 ], who also reported significantly improved Body Image Scale (BIS) and cosmetic scores for the LESS surgery group compared with the CL group. The transumbilical single-port approach utilizes the natural folds of the umbilicus, enabling an almost “scarless” surgical effect, which represents an important aesthetic advantage. Although the da Vinci robotic surgical system has seen increasingly widespread clinical usage in recent years [ 24 ], the experience and data accumulated at our center in the diagnosis and treatment of pelvic masses during pregnancy indicate that traditional LESS surgery remains the optimal choice in the majority of cases. This judgment is based on the following considerations: first, surgery during pregnancy has special requirements, including time constraints for emergency procedures, the precise control of operative traditional LESS surgery, robotic surgery offers no significant therapeutic advantages, while being less cost-effective [ 25 ]. Therefore, for the surgical management of pelvic masses during pregnancy, we strongly recommend traditional LESS surgery as the preferred approach. The main strengths of the present study lie in its provision of surgical data from the second and third trimesters, and long-term infant follow-up results. The findings of this study demonstrate that LESS surgery, when performed by experienced surgeons, is a safe and feasible option for selected cases, although its widespread application requires further support from multicenter data. However, the limitations of this study must be acknowledged: The retrospective design carries a risk of selection bias, and moreover, the relatively small sample size ( n  = 59) may limit the statistical power to detect rare complications or subtle differences despite the multicenter design of the study. Furthermore, although the neurodevelopmental assessments revealed no significant differences, the study was underpowered to detect small effects. In addition, the TA group included a higher proportion of high-risk patients (for example, those with a history of pelvic surgery, moderate-to-severe endometriosis and severe pelvic adhesions), which may have exaggerated the intergroup differences to a certain extent. Future multicenter prospective studies with larger cohort sizes and longer follow-up periods (for example, ≥ 2 years) that will employ stricter matching or randomized grouping are required to further validate the applicative value of LESS surgery in pregnant women with pelvic masses complicated by high-risk factors.

A well-documented retrospective cohort study by Balinskaite et al. [ 1 ] in 2017, featuring almost 6.5 million pregnancies, revealed that the proportion of non-obstetric operations performed during pregnancy in the population accounted for approximately 0.7% of the cases. Besides GPMs, there were 3,062 cases of appendicectomy and 1,306 cases of cholecystectomy. The most common surgical group was abdominal (12,493, or 26.2%) followed by dental (5,365; 11.3%), nail-skin (4,762; 10.0%), orthopedic (4,563; 9.6%), ears, nose and throat (3,060; 6.4%), perianal (2,977; 6.3%) and breast (1,884; 4.0%). The types of gynecological tumors in pregnancy were found to be the same as those occurring in non-pregnancy, including physiological ovarian cysts and benign/malignant gynecological tumors [ 2 ], although the incidence of ovarian cysts, including follicular cysts, luteal cysts and those occurring in ovarian hyperstimulation syndrome, was higher [ 3 , 4 ]. In addition to the high suspicion of malignant ovarian tumors during pregnancy, GPMs associated with an acute abdomen (which can be caused by torsion cysts or rupture), with a tumor diameter > 10 cm, and which persist during the second and third trimesters, require surgery [ 5 ]. If not treated in time, diffuse peritonitis and septicemia may result in adverse pregnancy outcomes, such as stillbirth, abortion and premature delivery [ 6 ]. TA surgery remains common for large GPMs in pregnancy due to perceived technical limitations of CL surgery (for example, restricted visibility and uterine injury risk). However, this technique carries a higher risk of morbidity, including prolonged recovery and preterm labor risks [ 7 ]. Advances that have been made in equipment and surgical techniques have led to the widespread acceptance of CL surgery for GPMs. At present, several large sample studies have confirmed both the feasibility and safety of CL surgery for any non-obstetric disease during pregnancy [ 8 , 9 ]. The American College of Obstetricians and Gynecologists (ACOG) and The British Society for Gynaecological Endoscopy (BSGE) have also endorsed laparoscopy as a safe and minimally invasive abdominal surgery method throughout pregnancy [ 10 ]. Although CL is less invasive, its multiport approach may increase postoperative pain and scarring. LESS surgery could address these trade-offs through combining minimal invasiveness with improved cosmesis, and yet the safety and efficacy of this type of surgery during the second and third trimesters have yet to be fully evaluated. There continues to be a scarcity of published studies on LESS surgery in GPMs during mid- and late-term pregnancy, especially in terms of investigating the long-term impact on the fetus [ 11 , 12 ]. In the present cohort study, both the safety and feasibility of LESS surgery within the framework of gynecological surgery are retrospectively evaluated. Outcomes were compared with those of cases treated using different surgery procedures, supplemented by a review of recent literature on this subject (see Supplementary Material 1).

Supplementary Material 1. Literature report on LESS in second and third trimester. Supplementary Material 2. Supplementary Material 1. Literature report on LESS in second and third trimester. Supplementary Material 2.