Analysis and suggestions on the complications in 2000 cases of transvaginal natural orifice transluminal endoscopic surgery: Can it be a conventional surgery?

OBJECTIVE: To reflect on the complications of transvaginal natural orifice transluminal endoscopic surgery (vNOTES), identify the corresponding risk factors, and provide caution to surgeons when performing this novel surgery. METHODS: A retrospective study was carried out among 2000 patients in our hospital who underwent vNOTES between May 2019 and May 2022. Perioperative complications were stratified in chronological order and divided into those developed while establishing the vNOTES approach, during surgery, postoperatively, and 1 month after discharge. The complications were classified based on the Modified Clavien-Dindo classifications. The causes of each type III/IV complication were analyzed. RESULTS: Of the 2000 patients, 88 (4.4%) experienced complications, which is not higher than that reported in laparoendoscopic surgery in previous studies. Grade I, II, III, IV, and V complications developed in 19 (0.95%), 57 (2.85%), 11 (0.55%), 1 (0.05%), and 0 (0%) patients, respectively. Complications were developed while establishing the approach platform, during the surgery, postoperatively, and within 1 month after discharge in 5 (0.25%), 30 (1.50%), 50 (2.50%), and 3 (0.15%) patients, respectively. Eight patients (0.4%) underwent conversion, including five cases of rectal injury repair. CONCLUSION: The summarized suggestions were divided into three levels. Considering the security and effectiveness of vNOTES, it can be routinely used in various gynecologic operations. However, surgeons should focus on preoperative evaluation, strictly conduct preoperative disinfection, conform to prompt conversion during surgery, call for the presence of experienced doctors, and have routine use of antibiotics to prevent postoperative infections. TRIAL REGISTRATION: ChiCTR2100053483.

Impact of gasless vNOTES vs. traditional vNOTES on hemodynamic profiles and outcomes in patients with benign gynecological disease: study protocol of a randomized controlled trial.

BACKGROUND: Literature regarding the advantages of gasless vNOTES is insufficient. The aim of our study is to compare gasless vNOTES vs. traditional vNOTES on hemodynamic profiles and outcomes in patients with benign gynecological disease. We hypothesize that compared with those in the traditional vNOTES group, hemodynamic profiles will be changed less during gasless vNOTES, while safety can be promised. METHODS: This is a single-center, prospective, single-blind, randomized controlled clinical trial, which has been approved by the Institutional Review Board of Chengdu Women's and Children's Hospital on September 27, 2022. One hundred and twenty patients will be recruited and randomly assigned to either the traditional vNOTES group or the gasless vNOTES group in a 1:1 ratio. For patients allocated to the traditional vNOTES group, after insertion of one port through the vagina, CO2 gas is infused with a pressure of 12-14 mmHg; while for those allocated to the gasless vNOTES group, a special device is used as an abdominal wall-lifting device to facilitate gasless surgery. CO2 pneumoperitoneum will not be used during the whole gasless vNOTES procedure. The primary outcome is vital signs at different time points. The secondary outcomes include surgical conversion rate, duration of surgery and anesthesia, anesthetic consumption, intraoperative estimated blood loss, VAS and PONV scores at postoperative 2 h and 24 h, administration of vasopressor drugs from the beginning of general anesthesia induction to 15 min after endotracheal intubation, including times, dosage, and type, intraoperative and postoperative complications, time of first getting out of bed after surgery, and time of first eating after surgery, including light drink. DISCUSSION: This is the first randomized controlled trial to compare the impacts of gasless vNOTES vs. traditional vNOTES on hemodynamic profiles and outcomes in patients with benign gynecological disease. If a favorable effect and safety of gasless vNOTES for hemodynamic profiles and outcomes in patients are shown, gasless vNOTES would be an optimal treatment option for patients with benign gynecological disease. TRIAL REGISTRATION: The trial was registered at https://www.chictr.org.cn/showproj.html?proj=182441 with registration No. ChiCTR2200064779 on Oct 17, 2022.

Does transvaginal natural orifice transluminal endoscopic surgery affect female sexual function?: a prospective cohort study.

BACKGROUND: To evaluate the effect of transvaginal natural orifice transluminal endoscopic surgery (vNOTES) on female sexual function. METHODS: The trial was registered at the Chinese Clinical Trial Registry (ChiCTR2100050887, 07/09/2021). In this prospective cohort study, we prospectively analyzed the data of the female sexual function index (FSFI) questionnaire of 130 patients who underwent laparoscopy in Chengdu Women's and Children's Central Hospital due to gynecological benign diseases. The patients were assigned to the vNOTES group and the control group (underwent traditional laparoscopic surgery or transumbilical laparoendoscopic single-site surgery). RESULTS: There were 4 cases dropout in the vNOTES group and 2 cases dropout in the control group. There was no difference in the ages (31.70 ± 5.02 vs. 30.37 ± 5.74, P>0.05), BMI (body mass index, 21.76 ± 3.16 vs. 23.30 ± 2.69, P>0.05), Education level, surgical types, and FSFI scores (22.31 ± 2.25 vs. 21.55 ± 3.38) between the vNOTES group and the control group before surgery. There was no difference in FSFI scores six months postoperation between the vNOTES group and the control group (21.61 ± 3.22 vs. 20.99 ± 3.26, P>0.05), and there was no difference in FSFI scores pre- and six months postoperation in vNOTES group (21.61 ± 3.22 vs. 22.31 ± 2.25, P>0.05). The time to start sexual life after surgery in the vNOTES group was later than that in the control group (39.34 ± 0.71 d versus 37.86 ± 0.69 d, P < 0.05). CONCLUSIONS: vNOTES has no significant adverse effect on female sexual function, however, the time to start sexual life after vNOTES is later than that after trans-abdominal laparoscopy.

Umbilical artery thrombosis and maternal positive autoimmune antibodies: two case reports and a literature review.

Background: Previous studies have shown that abnormal increases in autoimmune antibodies in pregnant women may increase the risk of maternal thrombosis. However, at our hospital, two pregnant women presented with umbilical artery thrombosis and positive maternal autoantibodies were detected in both, which led us to consider whether maternal autoantibodies also played a role in umbilical artery thrombosis. Case presentation: Case 1: Fetal ultrasound of a 34-year-old pregnant woman at 30+4 weeks gestation showed two umbilical arteries, with an inner diameter of approximately 0.15 cm for the smaller was artery. However, only a single umbilical artery blood flow signal was detected. Due to fetal distress, which was noted on abnormal cardiotocography and Doppler ultrasound, an emergency cesarean section was performed at 31+1 weeks gestation. The Apgar score of the newborn was 3-8-8. Umbilical cord examination detected thrombosis in the two umbilical arteries. Moreover, blood test results during pregnancy showed nRNP/Sm antibody (+) and SS antibody (+++). Case 2: The first systematic ultrasound of a 33-year-old twin pregnancy at 24+3 weeks gestation was normal, but routine fetal ultrasound at 27+1 weeks gestation showed only one umbilical artery between fetus A and the placenta. Blood test results showed that the patient was anti-nRNP/Sm antibody (+) in the rheumatoid immune activity test at 27+3 weeks gestation. An emergency cesarean section was performed at 34+6 weeks gestation because of the single umbilical artery and abnormal maternal coagulation. Both umbilical cords of fetus A and B blood test results showed anti-nRNP/Sm antibody (++). The pathological examination of the umbilical cord and placenta showed the presence of old thrombosis in one of the umbilical arteries of fetus A. Conclusions: Abnormal maternal autoantibodies may be a risk factor for umbilical artery thrombosis. For these pregnant women, conducting more detailed ultrasound monitoring might get early detection of UAT formation and avoid the occurrence of adverse pregnancy outcomes.

Epidemic history investigation: a new method of finding close contacts.

Introduction: Coronavirus disease 2019 has become a major global public health concern in December 2019. However, finding and excluding close contacts of COVID-19 infectors is a critical but difficult issue. This study aimed to introduce a new method of epidemiological investigation named space-time companions, which was adopted in Chengdu, China, in November 2021. Methods: An observational investigation was conducted during a small outbreak of COVID-19 in Chengdu, China in November 2021. A new method of epidemiological investigation called space-time companion was adopted in this outbreak, which was defined as the one who stayed in the same spatiotemporal grid (range: 800 m * 800 m) with the confirmed COVID-19 infector for more than 10 min in the last 14 days. A flow chart was used to describe the screening process of space-time companions in detail and illustrate the space-time companion epidemic management method. Results: The COVID-19 epidemic outbreak in Chengdu was effectively controlled for approximately one incubation period (14 days). After four rounds of space-time companions screening, more than 450,000 space-time companions were screened, including 27 COVID-19 infectors. Moreover, in the subsequent rounds of nucleic acid testing for all people in the city, no infected person were found proving the end of this epidemic outbreak. Conclusion: The space-time companion provides a new idea for screening close contacts of the COVID-19 infector and other similar infectious diseases, which can serve as a supplement to traditional epidemiological history surveys to verify and avoid missing close contacts.

MRI-based scoring model to predict massive hemorrhage during dilatation and curettage in patients with cesarean scar pregnancy.

OBJECTIVE: To construct a scoring model based on MRI signs to predict massive hemorrhage during dilatation and curettage in cesarean scar pregnancy (CSP) patients. MATERIALS AND METHODS: The MRIs of CSP patients admitted to a tertiary referral hospital between February 2020 and July 2022 were retrospectively reviewed. The included patients were randomly assigned to the training and validation cohorts. The univariate and multivariate logistic regression analyses were adopted to identify the independent risk factors for massive hemorrhage (the amount of bleeding ≥ 200 ml) during the dilatation and curettage. A scoring model predicting intraoperative massive hemorrhage was established where each positive independent risk factor was assigned 1 point, and the predictive power of this model was evaluated both in the training and validation cohorts via the receiver operating characteristic curve. RESULTS: A total of 187 CSP patients were enrolled, who were divided into the training cohort (31 in 131 patients had massive hemorrhage) and validation cohort (10 in 56 patients had massive hemorrhage). The independent risk factors for intraoperative massive hemorrhage included cesarean section diverticulum area (OR = 6.957, 95% CI 1.993-21.887; P = 0.001), uterine scar thickness (OR = 5.113, 95% CI 2.086-23.829; P = 0.025) and gestational sac diameter (OR = 3.853, 95% CI 1.103-13.530; P = 0.025). A scoring model with a total point of 3 was developed and the CSP patients were divided into low-risk (Total points < 2) and high-risk groups (Total points ≥ 2) for intraoperative massive hemorrhage accordingly. This model possessed high prediction performance both in the training cohort (area under the curve [AUC] = 0.896, 95% CI 0.830-0.942) and validation cohort (AUC = 0.915, 95% CI 0.785-1.000). CONCLUSION: We first constructed a MRI-based scoring model for predicting intraoperative massive hemorrhage in CSP patients, which could help the decision-making of the patients' therapy strategies. Low-risk patients can be cured by D&C alone to reduce the financial burden, while high-risk patients require more adequate preoperative preparation or consideration of changing surgical approaches to reduce bleeding risk.

The Pure Extraperitoneal Approach for Sacrocolpopexy in Transvaginal Natural-Orifice Transluminal Endoscopic Surgery.

Objective: The goal of this research was to investigate the feasibility, safety, and short-term clinical outcome of pure extraperitoneal sacrocolpopexy with transvaginal natural orifice transluminal endoscopic surgery (V-NOTES) for treating central pelvic defects. Material and Methods: A total of 9 patients with central pelvic prolapse underwent extraperitoneal sacrocolpopexy with V-NOTES, at the Chengdu Women's and Children's Central Hospital, Chengdu, Sichuan, China, between December 2020 and June 2022. The patients' demographic characteristics, perioperative parameters, and clinical outcomes were analyzed retrospectively. Each patient had the following major surgical procedures: (1) Establishing a platform for an extraperitoneal approach with V-NOTES; (2) separating the extraperitoneal path to the sacral promontory region; (3) suturing the long arm of the mesh to the anterior longitudinal ligament S1; and (4) suturing and fixating the short arm of the mesh at the top of the vagina. Results: The median patient age was 55, the median operative time was 145 minutes, and the median intraoperative blood loss was 150 mL. The operations were successful for all 9 cases, with a median preoperative Pelvic Organ Prolapse-Quantification score of C: +4, and a 3-months postoperative score of C: -6. There were no recurrences during a follow-up of 3-11 months, and no complications occurred, such as mesh erosion, exposure, and infection. Conclusion: As a new surgical approach, extraperitoneal sacrocolpopexy with V-NOTES is safe and feasible. (J GYNECOL SURG 39:108).

Transvaginal natural orifice transluminal endoscopic surgery versus conventional vaginal surgery for sacrospinous ligament fixation of apical compartment prolapse: a retrospective analysis.

BACKGROUND: To objectively assess the safety, feasibility, advantages, and disadvantages of transvaginal natural orifice transluminal endoscopic surgery (vNOTES) versus conventional vaginal (CV) surgery for sacrospinous ligament fixation (SSLF). METHODS: We retrospectively analyzed the data of patients who underwent hysterectomy for SSLF via vNOTES or CV surgery due to apical compartment prolapse between April 2019 and April 2020 at our hospital. The patients were classified into the vNOTES group (n = 31) and CV surgery group (n = 51) based on surgical approach and their general characteristics and perioperative outcomes compared. RESULTS: The two groups had similar general characteristics. The anatomical success and bilateral salpingo-oophorectomy rates were higher in the vNOTES than CV surgery group, while the postoperative stay was shorter in the vNOTES than CV surgery group. All differences were statistically significant. However, there were no statistically significant intergroup differences in operation time, bilateral salpingectomy rate, colporrhaphy rate, postoperative visual analog scale score, estimated blood loss, hemoglobin decrease at 72 h postoperative, maximum body temperature at 72 h postoperative, complication rate, buttock pain, or Pelvic Floor Impact Questionnaire-7 and Pelvic Floor Distress Inventory Questionnaire-20 scores at 1 year postoperative. CONCLUSIONS: VNOTES for SSLF was safe and feasible and resulted in superior objective and subjective outcomes versus CV surgery for SSLF. These findings suggest that vNOTES could be an alternative to CV surgery for SSLF.

Sentinel Lymph Node Mapping and Staging Surgery Via Gasless Transvaginal Natural Orifice Transluminal Endoscopic Surgery: A Case Report of an Endometrial Cancer Patient and Comorbid Rheumatic Heart Disease.

BACKGROUND Conventional laparoscopic surgery and transvaginal natural orifice transluminal endoscopic surgery (vNOTES) both use CO2 pneumoperitoneum to expose the surgical space. However, CO2 pneumoperitoneum is undoubtedly dangerous for patients with rheumatic heart disease (RHD) and can cause cardiopulmonary impairments. Therefore, we selected the sentinel lymph node (SLN) mapping strategy to guide the staging surgery via gasless vNOTES for an endometrial cancer (EC)-patient with comorbid RHD. Here, we discuss whether our selected surgical method was safe and feasible for this patient. CASE REPORT A 43-year-old woman with a history of RHD, severe mitral regurgitation, and pulmonary hypertension for more than 30 years received diagnostic curettage for irregular vaginal bleeding for more than 1 month. Pathological examinations revealed the occurrence of highly differentiated intrauterine endometrioid adenocarcinoma. She was admitted to the gynecological ward of our hospital for further surgery. We performed EC staging surgery with SLN mapping via gasless vNOTES and adopted a series of effective measures to solve the intraoperative complications of surgical space exposure. Surgery was successful. The patient recovered well and was discharged 5 days after surgery. She has been followed up in the gynecological clinic for nearly 1 year. At the time of this report, she had good recovery, no recurrence and metastasis, and normal tumor markers. CONCLUSIONS For EC patients with comorbid RHD pathology, application of staging surgery with SLN mapping via gasless vNOTES was shown to be safe and feasible. This approach is expected to be highly effective for patients with contraindications to CO2 pneumoperitoneum laparoscopy.

Transvaginal natural orifice transluminal endoscopic surgery in gynecological procedure: Experience of a Women's and Children's Medical Center from China.

OBJECTIVE: To review of our hospital's experiences in transvaginal natural orifice transluminal endoscopic surgery (vNOTES) and challenges we encountered in performance of the procedure, so as to provide help to medical institutions who are preparing to carry out vNOTES. METHODS: We retrospectively analyzed the data of all patients receiving vNOTES in our hospital from April 2018 to May 2021. Data we collected cover the general characteristics, perioperative outcomes, and complications of the patients. RESULTS: A total of 1147 patients underwent vNOTES in the past 3 years at our hospital. The total numbers of adnexal surgery, myomectomy, hysterectomy, pelvic floor reconstruction surgery, and malignant tumor surgery performed via vNOTES were 902, 98, 82, 51, and 14, respectively. Eighteen patients were converted to transabdominal laparoscopic surgery. A total of 38 patients had complications according to Clavien-Dindo classification, and the total complication rate was 3.31%. Among these cases of complications, 27 were Grade I, 4 were Grade II, and 7 were Grade III. No complications of Grade IV or V were reported. CONCLUSION: The application of vNOTES is safe and feasible for most gynecological surgeries. Moreover, hospitals with traditional laparoscopic equipment are advised to try this technique as there is no need to purchase additional expensive equipment. However, since vNOTES represents a novel approach, the long-term complications and efficacy associated with this technique are pending to be verified through large-scale prospective multicenter randomized controlled studies.

Hysteropreservation versus hysterectomy in uterine prolapse surgery: a systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: Hysteropreservation and hysterectomy for uterine prolapse have been compared in several randomized controlled trials (RCTs), as the best treatment has not been definitively determined. This study aimed to summarize the available evidence in RCTs of hysteropreservation versus hysterectomy. METHODS: We performed electronic searches in the PubMed, Embase, Cochrane Library, and China National Knowledge Infrastructure databases for eligible RCTs from inception to June 2020. The relative risks (RRs) and weighted mean differences (WMDs) with corresponding 95% confidence intervals (CIs) were calculated for categorical and continuous variables using random-effects models. RESULTS: Twelve RCTs involving 1177 patients were selected for meta-analysis. There were no significant differences between hysteropreservation and hysterectomy for the incidences of recurrence (RR, 0.55; 95% CI, 0.26-1.19; P = 0.130) and reoperation (RR, 1.15; 95% CI, 0.56-2.37; P = 0.705). Moreover, neither hysteropreservation nor hysterectomy had any significant effect on the risk of constipation (RR, 0.72; 95% CI, 0.15-3.46; P = 0.681), voiding dysfunction (RR, 0.99; 95% CI, 0.54-1.84; P = 0.981), intraoperative bleeding (RR, 0.35; 95% CI, 0.05-2.26; P = 0.271), upper leg dullness (RR, 0.70; 95% CI, 0.15-3.17; P = 0.643), dyspareunia (RR, 1.47; 95% CI, 0.69-3.13; P = 0.317), and wound infection (RR, 1.38; 95% CI, 0.24-7.80; P = 0.714). Furthermore, hysteropreservation was associated with less intraoperative blood loss (WMD, -25.68; 95% CI, -44.39 to -6.96; P = 0.007), shorter duration of surgery (WMD, -11.30; 95% CI, -19.04 to -3.55; P = 0.004), and shorter duration of hospitalization (WMD, -0.63; 95% CI, -1.10 to -0.16; P = 0.009) compared with hysterectomy. CONCLUSION: This study found that both hysteropreservation and hysterectomy have similar effects on recurrence and reoperation rates, while hysteropreservation was superior to hysterectomy in reducing intraoperative blood loss and shortening the duration of surgery and hospitalization.

Comparative analysis of vaginal natural orifice transluminal endoscopic surgery versus transumbilical laparoendoscopic single-site surgery in ovarian cystectomy.

AIM: To objectively assess the safety, feasibility, advantages and disadvantages and health economics benefits of vaginal natural orifice transluminal endoscopic surgery (vNOTES) versus transumbilical laparoendoscopic single-site surgery (TU-LESS) in ovarian cystectomy. METHODS: We retrospectively analyzed the data of all patients in our hospital who had undergone vNOTES and TU-LESS ovarian cystectomy due to 'unilateral ovarian cyst' from March 2019 to May 2020. Patients were classified into vNOTES group (86) and TU-LESS group (210) based on surgical paths. The patients' general characteristics and perioperative outcomes were compared. RESULTS: All 296 patients completed surgery with no need to switch to conventional laparoscopy or laparotomy procedures. There were no complications of Grade III, IV, V in Clavien-Dindo classification. There were two patients in the vNOTES group and four patients in the TU-LESS group with complications of Grade I, all of whom were treated with antipyretic drugs for postoperative fever. One patient in the TU-LESS group presented the complication of Grade II and was treated with blood transfusion due to postoperative anemia. The two groups had similar general characteristics. Perioperative outcomes: The visual analogue scale (VAS) scores 24 h postoperation were significantly lower in the vNOTES group than in the TU-LESS group. The cosmetic scores were significantly higher in the vNOTES group than in the TU-LESS group. Postoperative stay and time of flatus after surgery were significantly shorter in the vNOTES group than in the TU-LESS group. There was not significant statistical differences between the two groups in operation time, estimated blood loss, Hb decrease at 48 h postoperation, maximum body temperature in 48 h after surgery and hospital costs. CONCLUSION: It was proved to be safe and feasible in ovarian cystectomy by vNOTES. It worked better than TU-LESS in relieving postoperative pain, shortening postoperative stay and improving cosmetic effects and so on. As an emerging surgical path, large sample multicenter randomized controlled trials are required to further verify its safety and advantages.