Comparison of the survival outcomes of laparoscopic, abdominal and gasless laparoscopic radical hysterectomy for early-stage cervical cancer: trial protocol of a multicenter randomized controlled trial (LAGCC trial).

Background: Radical hysterectomy (RH) is considered a cornerstone in the treatment of early-stage cervical cancer. However, the debate surrounding the optimal surgical approach, whether minimally invasive or open surgery, remains controversial. The objective of this trial is to evaluate the survival outcomes of cervical cancer patients who undergo different surgical approaches. Methods: This study is designed as a prospective, multicenter, open, parallel, and randomized controlled trial. A total of 500 patients diagnosed with stage IA1 with LVSI, IA2, IB1, or IB2 (2018 FIGO) will be recruited. Recruitment of participants started in November 2020. The participants will be randomly assigned to one of three groups: conventional laparoscopic RH, gasless laparoscopic RH, or abdominal RH. The primary endpoint of this trial is the 2-year disease-free survival (DFS) rate. The secondary endpoints will include the 2-year overall survival (OS) rate, 5-year DFS/OS, recurrence rates, operation time, intraoperative blood loss, surgery-related complications, and impact on quality of life (QoL). Discussion: We expect this trial to provide compelling and high-quality evidence to guide the selection of the most appropriate surgical approach for early-stage cervical cancer. Clinical trial registration: Chinese Clinical Trial Register, identifier ChiCTR2000035515.

Patterns of recurrence in FIGO stage IB1-IB2 cervical cancer: Comparison between minimally invasive and abdominal radical hysterectomy.

OBJECTIVE: Aim of our study was to evaluate whether the different laparotomic (ARH) or minimally invasive (laparoscopic and robotic) approaches (MIS) in FIGO stage IB1-IB2 cervical cancer, present different patterns of recurrence of the disease. The secondary endpoint of the study was the evaluation of the variables most involved with the risk of relapse and therefore lower DFS and OS. MATERIAL AND METHODS: The study enrolled patients with definitive histological diagnosis of squamous or adenocarcinoma stage IB1-IB2 cervical cancer who underwent minimally invasive or abdominal radical hysterectomy from 2001 to 2018. RESULTS: The study enrolled 360 patients and 59 patients (16.4 %) reported a disease relapse. The data showed that ARH group was not associated with different recurrence patterns than MIS group (p = 0.14). Moreover, there was no statistically significant difference regarding DFS (p = 0.52) and OS (p = 0.29) between the ARH group and the MIS group. CONCLUSIONS: MIS, in FIGO stage IB1-IB2 cervical cancer, is not associated with different relapse patterns compared to ARH, nor with a higher risk of distance metastasis and finally, without significant difference in term of DFS and OS. More studies are needed to determine the factors that modify the site of relapse.

A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IB3 and IIA2): study protocol of the LAUNCH 3 trial.

BACKGROUND: Cervical cancer is and will remain to be an important health problem in China, especially with an increasing proportion of younger patients who has more specific needs. In China, surgery to remove tumor burden followed by postoperative treatment with radiotherapy and chemotherapy based on clinicopathologic factors may be the best choice for stages IB3 and IIA2 patients. Radical hysterectomy in cervical cancer has been a classic landmark surgery in gynecology. The current trial is designed to evaluate whether there is a difference between laparoscopic RH and abdominal RH in cervical cancer (stages IB3 and IIA2) patient survival under stringent operation standards and consistent surgical oncologic principles. This paper reports the rationale, design, and implementation of the trial. METHODS/DESIGN: This is an investigator-initiated, prospective, randomized, open, blinded endpoint (PROBE) controlled trial. A total of 1104 patients with stage IB3 and IIA2 cervical cancer will be enrolled over a period of 3 years. Patients are randomized (1:1) to either the laparoscopic RH or the abdominal RH group. Patients will then be followed up for at least 5 years. The primary end point will be 5-year overall survival, and secondary endpoints include 5-year progression-free survival, recurrence, and quality of life measurements. DISCUSSION: The study results will provide more convincing evidence-based information for stages IB3 and IIA2 cervical cancer patients and their gynecologic cancer surgeons in their choice of surgical method. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04939831 , retrospectively registered on 25 June 2021.

Learning Laparoscopic Radical Hysterectomy: Are We Facing an Emerging Situation?

Despite wide screening campaigns and early detection, cervical cancer remains the fourth most common cancer among women. Radical hysterectomy, whether by open, laparoscopic or by robotic-assisted techniques, is the mainstay treatment. However, for adequate surgical results and good oncological prognosis, a gynecological surgeon should be trained to perform those procedures. The learning curve of radical hysterectomy, especially by laparoscopy, is influenced by several factors. The LACC trial, the decrease in cervical cancer incidence and radical hysterectomy procedures have widely reduced the learning curve for surgeons. This article mainly discusses the learning curve of laparoscopic radical hysterectomy for cervical cancers, and how several factors are influencing it negatively, with the need to have medical authorities reset specific surgical training programs and allocate them to special oncological centers.

Survival after minimally invasive radical hysterectomy without using uterine manipulator for early-stage cervical cancer: A systematic review and meta-analysis.

BACKGROUND: Minimally invasive radical hysterectomy has been reported to increase the risk of cancer relapse and death compared with open surgery in women with early-stage cervical cancer. The use of a uterine manipulator is considered one of the risk factors. OBJECTIVES: To investigate whether women with early-stage cervical cancer treated with minimally invasive radical hysterectomy without using uterine manipulator have oncological outcomes similar to those of open surgery. SEARCH STRATEGY: Searches were performed in MEDLINE, Embase and CENTRAL from their inception until 31 March 2022. SELECTION CRITERIA: Inclusion criteria were: (1) randomised controlled trials or observational cohort studies published in English, (2) studies comparing minimally invasive radical hysterectomy without using a uterine manipulator with open radical hysterectomy in women with early-stage cervical cancer, and (3) studies comparing survival outcomes. DATA COLLECTION AND ANALYSIS: Two authors independently conducted data extraction and assessed study quality. We calculated the hazard ratios (HR) and the 95% confidence intervals (CI) using the inverse variance approach for survival outcome. MAIN RESULTS: Six observational studies with 2150 women were included. The minimally invasive surgery group had a significantly higher risk of cancer relapse compared with open surgery group (HR 1.55, 95% CI 1.15-2.10). CONCLUSIONS: Minimally invasive radical hysterectomy without using a uterine manipulator resulted in an inferior recurrence-free survival compared with open radical hysterectomy in the treatment of women with early-stage cervical cancer.

Evaluation of Surgical Outcomes of Abdominal Radical Hysterectomy and Total Laparoscopic Radical Hysterectomy for Cervical Cancer: A Retrospective Analysis of Data Collected before the LACC Trial.

Although a surgical approach is one of the key treatments for stages IA1-IIA2, results of the Laparoscopic Approach to Cervical Cancer (LACC) published in 2018 radically changed the field, since minimally invasive surgery was associated with a four-fold higher rate of recurrence and a six-fold higher rate of all-cause death compared to an open approach. We aimed to evaluate surgical outcomes of abdominal radical hysterectomy (ARH) and total laparoscopic radical hysterectomy (TLRH) for cervical cancer, including data collected before the LACC trial. In our retrospective analysis, operative time was significantly longer in TLRH compared to ARH (p < 0.0001), although this disadvantage could be considered balanced by lower intra-operative estimated blood loss in TLRH compared with ARH (p < 0.0001). In addition, we did not find significant differences for intra-operative (p = 0.0874) and post-operative complication rates (p = 0.0727) between ARH and TLRH. This was not likely to be influenced by age and Body Mass Index, since they were comparable in the two groups (p = 0.0798 and p = 0.4825, respectively). Finally, mean number of pelvic lymph nodes retrieved (p = 0.153) and nodal metastases (p = 0.774), as well as death rate (p = 0.5514) and recurrence rate (p = 0.1582) were comparable between the two groups. Future studies should be aimed at assessing whether different histology/grades of cervical cancer, as well as particular subpopulations, may have significantly different outcomes using minimally invasive surgery or laparotomy, with or without neoadjuvant chemotherapy.

Survival Outcomes of Patients With Stage IB3 Cervical Cancer Who Undergo Abdominal Radical Hysterectomy Versus Radiochemotherapy.

Objective: This study aimed to compare the survival outcomes among stage IB3 cervical cancer patients who undergo abdominal radical hysterectomy (ARH)+pelvic lymphadenectomy ± para-aortic lymph node dissection versus radiochemotherapy (R-CT). Methods: Based on the large number of diagnoses and treatments for cervical cancer in the Chinese database, propensity score matching (PSM) was used to compare the 5-year overall survival (OS) and disease-free survival (DFS) rates of the ARH group and R-CT group. Results: There were 590 patients with stage IB3 cervical cancer according to the FIGO 2018 staging system, with 470 patients in the ARH group and 120 patients in the R-CT group. The ARH and R-CT groups showed different 5-year OS and DFS rates in the total study population, and the 5-year OS and DFS rates in the R-CT group (n = 120) were lower than those in the ARH group (n = 470) (OS: 78.1% vs. 92.1%, p < 0.001; DFS: 71.6% vs. 90.3%, p < 0.001). R-CT was associated with a worse 5-year OS rate (hazard ratio [HR] = 3.401; 95% confidence interval [CI] = 1.875-6.167; p < 0.001) and DFS rate (HR = 3.440; 95% CI = 2.075-5.703; p < 0.001) by Cox multivariate analysis. After 1:3 PSM, the 5-year OS and DFS rates in the R-CT group (n = 108) were lower than those in the RH group (n = 280) (OS: 76.4% vs. 94.0%, p < 0.001; DFS: 69.3% vs. 92.6%, p < 0.001, respectively). R-CT was associated with a worse 5-year OS rate (HR = 4.071; 95% CI = 2.042-8.117; p < 0.001) and DFS rate (HR = 4.450; 95% CI = 2.441-8.113; p < 0.001) by Cox multivariate analysis. Conclusion: Our study found that for FIGO 2018 stage IB3 cervical cancer patients, ARH resulted in better OS and DFS than R-CT.

A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IA1 with LVSI, IA2): study protocol of the LAUNCH 1 trial.

BACKGROUND: A retrospective study and a randomized controlled trial published in a high quality journal in late 2018 have shown that laparoscopic radical hysterectomy (RH) was associated with worse survival than abdominal RH among patients with early stage cervical cancer. Radical hysterectomy in cervical cancer has been a classic landmark surgery in gynecology, therefore this conclusion is pivotal. The current trial is designed to reconfirm whether there is a difference between laparoscopic RH and abdominal RH in cervical cancer (stage IA1 with LVSI, IA2) patient survival under stringent operation standards and consistent tumor-free technique. This paper reports the rationale, design, and implementation of the trial. METHODS: This is an investigator-initiated, prospective, randomized, open, blinded endpoint (PROBE) controlled trial. A total of 690 patients with stage IA1 (with intravascular), and IA2 cervical cancer will be enrolled over a period of three years. Patients are randomized (1:1) to either the laparoscopic RH or the abdominal RH group. Patients will then be followed-up for at least five years. The primary endpoint will be 5-year progression-free survival. Secondary endpoints will include 5-year overall survival rates, recurrence rates, operation time, intraoperative blood loss, surgery-related complications, and quality of life. DISCUSSION: The results of the trial will provide valuable evidence for guiding clinical decision of choosing appropriate treatment strategies for stage IA1 (LVSI) and stage IA2 cervical cancer patients. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT04934982 , Registered on 22 June 2021).

A multicenter non-inferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stages IB1, IB2, and IIA1): study protocol of the LAUNCH 2 trial.

BACKGROUND: A retrospective study and a randomized controlled trial published in late 2018 have shown that laparoscopic radical hysterectomy (RH) was associated with worse survival than abdominal RH among patients with early-stage cervical cancer. Radical hysterectomy in cervical cancer has been a classic landmark surgery in gynecology; therefore, this conclusion is pivotal. The current trial is designed to reconfirm whether there is a difference between laparoscopic RH and abdominal RH in cervical cancer (stages IB1, IB2, and IIA1) patient survival under stringent operation standards and consistent surgical oncologic principles. METHODS/DESIGN: This is an investigator-initiated, Prospective, Randomized, Open, Blinded End-point (PROBE)-controlled non-inferiority trial. A total of 780 patients with stage IB1, IB2, and IIA1 cervical cancer will be enrolled over a period of 3 years. Patients are randomized (1:1) to either the laparoscopic RH or the abdominal RH group. Patients will then be followed up for at least 5 years. The primary endpoint will be 5-year progression-free survival, and secondary endpoints include 5-year overall survival, recurrence, and quality of life measurements. DISCUSSION: The debate on laparoscopic versus abdominal RH is still ongoing, and high-quality evidences are needed to guide clinical practice. The study results will provide more convincing evidence-based information for early-stage cervical cancer patients and their gynecologic cancer surgeons in their choice of surgical method. TRIAL REGISTRATION: ClinicalTrials.gov NCT04929769 . Registered on 18 June 2021.

The Impaction of Laparoscopic versus Laparotomy for Lymphovascular Space Invasion of Early Cervical Cancer: A Multicenter Retrospective Study.

Objectives: The aim of this study was to compare the lymphovascular space invasion between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH). Materials and Methods: One retrospective study was conducted with 391 patients treated with 242 patients underwent ARH and 149 patients underwent LRH between May 2010 and August 2019. We collected clinicopathological and perioperative outcome from medical records. We adopt Student's t-test and Chi-square test was used to compare continuous and categorical variables between LRH and ARH. Results: Our research found that there was no difference in tumor size, histology, pathology grades, positive lymph nodes, and postoperative complications between LRH and ARH (P > 0.05). The estimated blooding loss (EBL) and length of postoperative hospital stay were less for LRH than ARH (248.12 ml vs. 412.56 ml, P < 0.05, and 10.48 days vs. 15.16 days, P < 0.05). The mean operative time was longer for LRH than ARH (227.51 min vs. 215.62 min, P < 0.05). Significant difference was found in intraoperative complications (P < 0.05). However, LVSI was higher for LRH than ARH (36.8% vs. 19.8%, P < 0.05). We discovered that the LVSI was related with International Federation of Obstetrics and Gynecology stage and tumor size. Conclusion: Compared to ARH, the LRH would be advantageous for early cervical cancer in terms of EBL, length of postoperative hospital stay, and intraoperative complications. The ARH was superior to LRH in operative time. In addition to, LRH was more likely to lead to LVSI. Furthermore, when tumor size or stage was increasing, LRH was easily to generate LVSI. But, we cannot confirm recurrence rate is related to LVSI.

Evaluation of the efficacy of laparoscopic-assisted radical vaginal hysterectomy and abdominal radical hysterectomy for treating cervical cancer: a meta-analysis.

INTRODUCTION: Laparoscopic-assisted radical vaginal hysterectomy (LARVH) and abdominal radical hysterectomy (ARH) are commonly used for cervical cancer treatment. However, the clinical application of LARVH versus ARH in treating cervical cancer remains controversial. AIM: To investigate the efficacy of LARVH versus ARH in treating cervical cancer via comparing several inductors by pooling related studies. MATERIAL AND METHODS: Eligible articles from PubMed, Embase, and the Cochrane library were screened using established search terms. Consecutive variables were pooled using weighted mean difference (WMD) and 95% confidence interval (CI). Categorical variables were pooled using odds ratio (OR) and 95% CI. RESULTS: A total of 13 articles were included in this meta-analysis, comprising 579 patients who underwent LARVH and 810 who underwent ARH. LARVH required a longer operation time (WMD = 50.97, 95% CI: 38.34, 63.59, p < 0.001) than ARH. However, compared to patients who underwent ARH, those who underwent LARVH had less bleeding volume (WMD = -311.21, 95% CI: -482.77, -139.64, p < 0.001), required a shorter hospital stay (WMD = -3.38, 95% CI: -5.00, -1.76, p < 0.001), and had a lower risk of urinary tract infection (OR = 0.34, 95% CI: 0.13, 0.89, p = 0.028). Additionally, patients who underwent LARVH showed a slightly lower recurrence rate (OR = 0.549, 95% CI: 0.302, 0.998, p = 0.049) than patients who underwent ARH. However, subgroup analysis results were not in agreement with the pooled results and indicated an unstable outcome. CONCLUSIONS: Owing to these reasons, LARVH has more application prospects than ARH in treating cervical cancer.

Efficacy evaluation of vaginal-assisted laparoscopic radical hysterectomy and laparoscopic radical hysterectomy for cervical cancer: a single-center retrospective case series study.

Background: To investigate the survival outcomes of abdominal radical hysterectomy (ARH), laparoscopic radical hysterectomy (LRH), and vaginal-assisted laparoscopic radical hysterectomy (VALRH) in the treatment of cervical cancer patients. Methods: This was a retrospective study. We collected the clinical data of 654 patients with cervical cancer (406 ARH, 172 LRH, and 76 VALRH), then compared the effects of different surgical methods on recurrence and survival. Results: Total overall survival (OS) were no significant differences in three groups (P>0.05). Total disease-free survival (DFS) was significantly higher in ARH group than in LRH group [hazard ratio (HR) =2.8, 95% confidence interval (CI): 1.199-3.607, P=0.004]; however, there were no significant differences between the VALRH (94.7%) and ARH (93.3%) groups. Subgroup stratification analysis showed that the overall recurrence rate in LRH group was significantly higher than that of the ARH groups for patients with a tumor size from ≥2 to <4 cm, negative postoperative lymph nodes, and no postoperative adjuvant therapy (all P<0.05). However, in the subgroup with tumor sizes of ≥2, <4, and ≥4 cm, no matter whether the lymph nodes were positive or not, and those with no postoperative supplementary adjuvant therapy, LRH was associated with a significantly higher local pelvic recurrence rate than ARH (all P<0.05). No significant differences between VALRH and ARH in any of the subgroup analyses (all P>0.05). A Cox analysis indicated that LRH increased the risk of overall and local pelvic recurrence after surgery compared with ARH (HR =2.338, 95% CI: 1.186-4.661, P=0.014; HR =10.313, 95% CI: 2.839-37.460, P<0.001); however, no significant difference between VALRH and ARH (all P>0.05). Sensitivity analysis of surgeons did not change the conclusions. Conclusions: Our analyses showed that the local pelvic recurrence rates and overall recurrence rates of LRH were significantly higher than ARH. VALRH could avoid tumor intraperitoneal exposure and achieve the same tumor prognosis as open surgery. By improving the standardization of minimally invasive surgery for early cervical cancer and paying close attention to the tumor-free concept, minimally invasive radical hysterectomy may achieve the same tumor outcome as open surgery.

A meta-analysis of survival after minimally invasive radical hysterectomy versus abdominal radical hysterectomy in cervical cancer: center-associated factors matter.

PURPOSE: To explore the possible factors that contributed to the poor performance of minimally invasive surgery (MIS) versus abdominal surgery regarding progression-free survival (PFS) and overall survival (OS) in cervical cancer. METHODS: MEDLINE, EMBASE, Cochrane Library and Web of Science were searched (January 2000 to April 2021). Study selection was performed by two researchers to include studies reported oncological safety. Summary hazard ratios (HRs) and 95% confidence intervals (CIs) were combined using random-effect model. Subgroup analyses were stratified by characteristics of disease, publication, study design and treatment center. RESULTS: Sixty-one studies with 63,369 patients (MIS 26956 and ARH 36,049) were included. The overall-analysis revealed a higher risk of recurrence (HR 1.209; 95% CI 1.102-1.327) and death (HR 1.124; 95% CI 1.013-1.248) after MIS versus ARH expect in FIGO IB1 (FIGO 2009 staging) patients with tumor size less than 2 cm. However, subgroup analyses showed comparable PFS/DFS and OS in studies published before the Laparoscopic Approach to Cervical Cancer (LACC) trial, published in European journals, conducted in a single center, performed in centers in Europe and in centers with high sample volume or high MIS sample volume. CONCLUSION: Our findings highlight possible factors that associated with inferior survival after MIS in cervical cancer including publication characteristics, center-geography and sample volume. Center associated factors were needed to be taken into consideration when evaluating complex surgical procedures like radical hysterectomy.

Neoadjuvant Chemotherapy Followed by Surgery Versus Abdominal Radical Hysterectomy Alone for Oncological Outcomes of Stage IB3 Cervical Cancer-A Propensity Score Matching Analysis.

OBJECTIVE: To compare the 5-year overall survival (OS) and disease-free survival (DFS) of patients with cervical cancer who received neoadjuvant chemotherapy followed by surgery (NACT) with those who received abdominal radical hysterectomy alone (ARH). METHODS: We retrospectively compared the oncological outcomes of 1410 patients with stage IB3 cervical cancer who received NACT (n=583) or ARH (n=827). The patients in the NACT group were divided into an NACT-sensitive group and an NACT-insensitive group according to their response to chemotherapy. RESULTS: The 5-year oncological outcomes were significantly better in the NACT group than in the ARH group (OS: 96.2% vs. 91.2%, respectively, p=0.002; DFS: 92.2% vs. 87.5%, respectively, p=0.016). Cox multivariate analysis suggested that NACT was independently associated with a better 5-year OS (HR=0.496; 95% CI, 0.281-0.875; p=0.015), but it was not an independent factor for 5-year DFS (HR=0.760; 95% CI, 0.505-1.145; p=0.189). After matching, the 5-year oncological outcomes of the NACT group were better than those of the ARH group. Cox multivariate analysis suggested that NACT was still an independent protective factor for 5-year OS (HR=0.503; 95% CI, 0.275-0.918; p=0.025). The proportion of patients in the NACT group who received postoperative radiotherapy was significantly lower than that in the ARH group (p<0.001). Compared to the ARH group, the NACT-sensitive group had similar results as the NACT group. The NACT-insensitive group and the ARH group had similar 5-year oncological outcomes and proportions of patients receiving postoperative radiotherapy. CONCLUSION: Among patients with stage IB3 cervical cancer, NACT improved 5-year OS and was associated with a reduction in the proportion of patients receiving postoperative radiotherapy. These findings suggest that patients with stage IB3 cervical cancer, especially those who are sensitive to chemotherapy, might consider NACT followed by surgery.

Long-term oncological outcomes and recurrence patterns in early-stage cervical cancer treated with minimally invasive versus abdominal radical hysterectomy: The Norwegian Radium Hospital experience.

OBJECTIVE: To compare long-term oncological outcomes in early-stage cervical cancer (CC) patients treated with minimally invasive radical hysterectomy (MIRH) versus abdominal radical hysterectomy (ARH), with a focus on recurrence patterns, tumor sizes, and conization. METHODS: This single-institution, retrospective study consisted of stage IA1-IB1 (FIGO 2009) squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma of the cervix, who underwent radical hysterectomy between 2000 and 2017. RESULTS: Of the 582 patients included, 353 (60.7%) underwent ARH, and 229 (39.3%) MIRH. The median follow-up was 14.4 years in the ARH group and 6.1 years in the MIRH group (p < 0.0001). Among the 96 stage IA patients, only 3 (3.1%) experienced recurrence. Among stage IB1 patients, the risk of recurrence, after adjusting for standard prognostic variables, was twofold higher in the MIRH group versus the ARH group (HR 2.73, 95% CI: 1.56-4.80), and the relative difference was similar in terms of risk of cancer-specific survival (CSS) (HR 3.04, 95% CI: 1.28-7.20) and overall survival (OS) (HR 2.35, 95% CI: 1.21-4.59). In stage IB1 ≤ 2 cm patients without conization MIRH was associated with reduced time to recurrence (TTR) (HR 4.00, 95% CI: 1.67-9.57), CSS (HR 3.71, 95% CI: 1.19-11.58) and OS (HR 3.02, 95% CI: 1.24-7.34). Intraperitoneal combined recurrences accounted for 12 of 30 (40.0%) recurrences in the MIRH group but were not identified after ARH (p = 0.0001). CONCLUSIONS: MIRH was associated with reduced TTR, CSS and OS versus ARH in stage IB1 CC patients. The risk of peritoneal recurrence was high, even for tumors ≤2 cm without conization.

Comparison of oncological outcomes and major complications between laparoscopic radical hysterectomy and abdominal radical hysterectomy for stage IB1 cervical cancer with a tumour size less than 2 cm.

OBJECTIVE: To compare the oncological outcomes and major complications of laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) for stage IB1 cervical cancer (FIGO 2009) with a tumour size less than 2 cm. METHODS: We retrospectively compared the oncological outcomes and major complications of 1207 stage IB1 cervical cancer patients with a tumour size less than 2 cm who received LRH (n = 546) or ARH (n = 661) in 37 hospitals. RESULTS: (1) There was no significant difference in 3-year overall survival (OS; 97.3% vs. 98.5%, P = 0.288) or 3-year disease-free survival (DFS; 95.1% vs. 95.4%, P = 0.792) between LRH (n = 546) and ARH (n = 661).(2) The rate of any 1 complication refers to the incidence of one or more complications in a patient, which was higher with LRH than ARH (OR = 4.047, 95% CI = 2.035-8.048, P < 0.001). Additionally, intraoperative complications occurred with LRH (OR = 12.313, 95% confidence intervals [CI] = 1.571-96.493, P = 0.017), and postoperative complications (OR = 3.652, 95% CI = 1.763-7.562, P < 0.001) were higher with LRH than ARH. The ureteral injury rate was higher with LRH than with ARH (1.50% vs. 0.20%, OR = 9.814, 95% CI = 1.224-78.712, P = 0.032). The ureterovaginal fistula rate was higher with LRH than ARH. The rates of obturator nerve injury, bladder injury, vesicovaginal fistula, rectovaginal fistula, venous thromboembolism, bowel obstruction, chylous leakage, pelvic haematoma, and haemorrhage were similar between the groups. CONCLUSIONS: The oncological outcomes of LRH and ARH for stage IB1 cervical cancer patients with a tumour size less than 2 cm do not differ significantly. However, incidences of any 1 complication, intraoperative complications, and postoperative complications were higher with LRH than ARH, with complications manifesting mainly as ureteral injury and uterovaginal fistula.

Comparison of survival outcomes between laparoscopic surgery and abdominal surgery for radical hysterectomy as primary treatment in patients with stage IB2/IIA2 cervical cancer.

OBJECTIVE: To investigate the long-term oncological outcomes of laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) for the treatment of stage IB2/IIA2 cervical cancer without preoperative adjuvant therapy. METHODS: We conducted a multicenter, retrospective, case-matching study. The differences in overall survival (OS) and disease-free survival (DFS) between the LRH and ARH were compared under the conditions of real-world study and case-control matching (1:1 matching). RESULTS: There was no significant difference in the outcomes of LRH (n = 580) and ARH (n = 1653) in 5-year OS and DFS (OS: 80.6% vs. 86.1%, p = 0.421; DFS: 78.6% vs. 80.7%, p = 0.376). After 1:1 matching, there was no difference in 5-year OS and DFS between LRH (n = 554) and ARH (n = 554) (OS: 80.4% vs. 84.5%, p = 0.993; DFS: 79.0% vs. 78.8%, p = 0.695). Before and after matching, the surgical approach was not an independent risk factor for 5-year OS and DFS, and postoperative adjuvant therapy affected patient prognosis. Further subgroup analysis suggested that there was no difference in LRH (n = 313) and ARH (n = 1092) in 5-year OS or DFS in patients who underwent standard postoperative adjuvant therapy (OS: 83.0% vs. 87.7%, p = 0.992; DFS: 79.0% vs. 82.5%, p = 0.323). After 1:1 pairing, the 5-year OS and DFS in LRH (n = 295) and ARH (n = 295) showed no difference. Before and after matching, the surgical approach was not an independent risk factor affecting the 5-year OS and DFS. CONCLUSIONS: There was no difference in the oncological outcomes between laparoscopic and abdominal surgery in patients with stage IB2/IIA2 cervical cancer without preoperative adjuvant therapy. CLINICAL TRIALS: The ethical approval number is NFEC-2017-135, and the clinical research registration number is CHiCTR1800017778 (International Clinical Trials Registry Platform Search Port, http://apps.who.int/trialsearch/).

Comparison of Minimally Invasive Versus Abdominal Radical Hysterectomy for Early-Stage Cervical Cancer: An Updated Meta-Analysis.

BACKGROUND: Although minimally invasive surgery (MIS) was commonly used to treat patients with early-stage cervical cancer, its efficacy remained controversial. METHODS: We systematically searched PubMed, Web of Science, and Cochrane Library databases until March 2021 to compare the prognosis of early-stage cervical cancer patients who underwent MIS (laparoscopic or robot-assisted radical hysterectomy) or ARH. The primary outcomes included rates of 3- and 5-year disease-free survival (DFS) and overall survival (OS). The study protocol was registered in PROSPERO: CRD42021258116. RESULTS: This meta-analysis included 48 studies involving 23346 patients (11220, MIS group; 12126, ARH group). The MIS group had a poorer medium-term (3-year) DFS (HR=1.08, 95% CI: 1.01-1.16, p=0.031) than the ARH group, without significant difference in medium-term OS as well as long-term (5-year) DFS and OS. Subgroup analysis of 3-year prognosis revealed that although patients in Western countries who underwent MIS had shorter DFS than those who underwent ARH (HR=1.10, p=0.024), no difference was observed in DFS among those in Asian countries. Moreover, MIS was linked to poorer 3-year DFS in patients with stage I cervical cancer (HR=1.07, p=0.020). Notably, subgroup analysis of 5-year prognosis revealed that patients with tumor size ≥2 cm undergoing MIS exhibited a shorter DFS than those who underwent ARH (HR=1.65, p=0.041). CONCLUSION: Patients with early-stage cervical cancer undergoing MIS may have a poorer prognosis than those undergoing ARH. Therefore, applying MIS in early-stage cervical cancer patients should be conducted with caution. SYSTEMATIC REVIEW REGISTRATION: The study protocol was registered in PROSPERO: CRD42021258116.

Comparison of long-term survival of total abdominal radical hysterectomy and laparoscopy-assisted radical vaginal hysterectomy in patients with early cervical cancer: Korean multicenter, retrospective analysis.

PURPOSE: The aim of this study was to compare survival outcomes of total abdominal radical hysterectomy (TARH) versus laparoscopy-assisted radical vaginal hysterectomy (LARVH) in stage IA2-IB2 cervical cancer. METHODS: 812 patients who underwent RH between 2008 and 2017 were evaluated in 3 institutions. Progression-free survival (PFS) and overall survival (OS) were analyzed with Kaplan-Meier method and compared by log-rank test. The clinical noninferiority of the LARVH to TARH was assessed with a margin of -7.2%. Noninferiority was demonstrated if the low limit of 95% confidence interval (CI) exceeded its predefined margin. RESULTS: 258 patients were treated with TARH and 252 patients with LARVH. TARH and LARVH group had similar 5-year PFS (84.4% vs 86.6%, p = 0.467) and OS rates (85.8% vs 88.0%, p = 0.919). Noninferiority of LARVH to TARH were confirmed with 5-year PFS and OS difference rates of 2.2% (95% CI -2.9-7.3, p = 0.001) and 2.2% (95% CI -2.7-7.1, p = 0.001), respectively. In subgroup of patients with tumors size >2 cm, 5-year PFS (77.6% vs 79.0%, p = 0.682) and OS rates (79.2% vs 81.5%, p = 0.784) did not differ statistically between the two groups. Noninferiority of LARVH to TARH were also confirmed with 5-year PFS and OS difference rates of 1.4% (95% CI -7.0-9.8, p = 0.046) and 2.3% (95% CI -5.8-10.4, p = 0.027), respectively. CONCLUSION: LARVH showed significant noninferiority for PFS and OS versus TARH in early cervical cancer, suggesting the potential oncologic safety of LARVH.

Comparison of urologic complications between laparoscopic radical hysterectomy and abdominal radical hysterectomy: A nationwide study from the National Health Insurance.

OBJECTIVE: This study aimed to assess the risks of intraoperative and postoperative urologic complications between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH). METHODS: Using the database of the National Health Insurance Service (NHIS) and Health Insurance Review & Assessment (HIRA), we identified all Korean women who underwent radical hysterectomy between 2006 and 2018. Intraoperative and postoperative urologic complications were compared between the ARH and LRH groups. RESULTS: A total of 11,399 patients were identified to ARH and 8435 patients to LRH. Urologic complications occurred in 292 of 19,774 patients (1.48%) who underwent radical hysterectomy. LRH was associated with higher complication rates than ARH, although with a borderline significance (OR: 1.23; 90% CI: 1.02-1.51, p = 0.066). There was no difference in intraoperative urologic complications between the ARH and the LRH groups (OR: 1.1 95% CI: 0.86-1.43, p < 0.435). The incidence of postoperative urologic complications was significantly higher in the LRH group (OR: 2.01; 95% CI: 1.18-3.47, p = 0.009). In terms of postoperative urologic complications, the risk of ureterovaginal fistula was not significant between the two groups (OR: 1.53; 95% CI: 0.54-4.24, p = 0.403), whereas the risk of vesicovaginal fistula was significantly higher in the LRH group (OR: 2.24; 95% CI: 1.09-4.58, p = 0.028). There were no significant differences in the overall and urinary tract-specific complications between ARH and LRH in groups under 40 years of age and during the second half (2013-2018), with 2012 as the boundary. CONCLUSION: Among specific urologic complications, the incidence of vesicovaginal fistula was significantly higher in the LRH group than in the ARH group.