Open Abdominal Radical Hysterectomy Research Articles

Ten-year outcomes following laparoscopic and open abdominal radical hysterectomy for “low-risk” early-stage cervical cancer: A propensity-score based analysis

ObjectiveAccumulating evidence suggested the detrimental effects of adopting minimally invasive surgery in the management of early-stage cervical cancer. However, long-term evidence on the role of minimally invasive radical hysterectomy in “low-risk” patients exists. MethodsThis is multi-institutional retrospective study comparing minimally invasive and open radical hysterectomy in low-risk early-stage cervical cancer patients. A propensity-score matching algorithm (1:2) was used to allocate patients into the study groups. Kaplan-Meir model was used to estimate 10-year progression-free and overall survival. ResultsCharts of 224 “low-risk” patients were retrieved. Overall, 50 patients undergoing radical hysterectomy were matched with 100 patients undergoing open radical hysterectomy. Minimally invasive radical hysterectomy was associated with a longer median operative time (224 (range, 100–310) vs. 184 (range, 150–240) minutes; p < 0.001), lower estimated blood loss (10 (10-100) vs. 200 (100−1000) ml, p < 0.001), and shorter length of hospital stay (3.8 (3-6) vs. 5.1 (4-12); p < 0.001). Surgical approach did not influence the risk of having intra-operative (4% vs. 1%; p = 0.257) and 90-day severe (grade 3+) postoperative complication rates (4% vs. 8%; p = 0.497). Ten-year disease-free survival was similar between groups (94% vs. 95%; p = 0.812; HR:1.195; 95%CI:0.275, 5.18). Ten-year overall survival was similar between groups (98% vs. 96%; p = 0.995; HR:0.994; 95%CI:0.182, 5.424). ConclusionsOur study appears to support emerging evidence suggesting that, for low-risk patients, laparoscopic radical hysterectomy does not result in worse 10-year outcomes compared to the open approach. However, further research is needed and open abdominal radical hysterectomy remains the standard treatment for cervical cancer patients.

The sealing effect of magnetic-sealing uterine manipulator in isolated uterus from patients with early-stage cervical cancer: a pre-clinical study.

Traditional uterine manipulator is considered as the main reason for short survival of patients with early-stage cervical cancer during minimally invasive surgery. This study aims to assess the sealing effect of magnetic-sealing uterine manipulators (MUMs) in isolated uteruses. The study was performed on isolated uterus from patients with early-stage cervical cancer who underwent open abdominal radical hysterectomy between November 2019 to April 2021. Right-angle forceps closure tests (groups 1 and 3) were defined as control tests. One experimental MUM closure test (group 2) and 2 control tests were respectively carried out in each of the isolated uterus. DNA ploidy analysis system was used to observe exfoliated cells. Statistical analysis was performed using Wilcoxon signed-rank test to assess the sealing effect of MUM. We identified 36 patients. No regional node metastasis was discovered and only one tumor was larger than 4.0 cm in diameter. The mean of exfoliated tumor cells in groups 1, 2, and 3 were 1, 1, and 2, respectively. There was no significant difference in the quantity of exfoliated cells between groups 1 and 3 (p=0.476), so the results of the 2 groups were merged. Subsequently, a significant difference was observed between combined right-angle forceps closure tests and MUM closure tests (p=0.022). The sealing effect of MUM was better than that of right-angle forceps. MUM can effectively seal cervical cancer cells in the cup cover, avoiding the dissemination of tumor cells. Chinese Clinical Trial Register Identifier: ChiCTR1900026012.

Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer: A Meta-analysis of Randomized Controlled Trials.

Laparoscopic radical hysterectomy (LRH) and open abdominal radical hysterectomy (ARH) have been used for cervical cancer treatment. We aimed to perform a meta-analysis to compare the efficacy and safety of LRH and ARH in the treatment of cervical cancer to provide reliable evidence to the clinical cervical cancer treatment. Two investigators independently searched PubMed and other databases for randomized controlled trials (RCTs) comparing LRH and ARH for cervical cancer treatment up to May 31, 2022. The risk of bias assessment tool recommended by Cochrane library was used for quality assessment. RevMan 5.3 software was used for meta-analysis. Fourteen RCTs with a total of 1700 patients with cervical cancer were finally included. Meta-analyses indicated that compared with ARH, LRH reduced the intraoperative blood loss (mean difference [MD]=-58.08; 95% CI, -70.91, -45.24), the time to first passage of flatus (MD=-14.50; 95% CI, -16.55, -12.44) (all P <0.05), and increase the number of lymph nodes removed (MD=3.47; 95% CI, 0.51, 6.43; P =0.02). There were no significant differences in the duration of surgery (MD=27.62; 95% CI, -6.26, 61.49), intraoperative complications (odd ratio [OR]=1.10; 95% CI, 0.17, 7.32), postoperative complications (OR=0.78; 95% CI, 0.33, 1.86), relapse rate (OR=1.45; 95% CI, 0.56, 3.74), and survival rate (OR=0.75; 95% CI, 0.52, 1.08) between LRH group and ARH group (all P >0.05). LRH has more advantages over ARH in the treatment of cervical cancer. Still, the long-term effects and safety of LRH and ARH need more high-quality, large-sample RCTs to be further verified.

Does Vaginal Cuff Creation and Avoidance of a Uterine Manipulator Improve the Prognosis of Total Laparoscopic Radical Hysterectomy for Early Cervical Cancer? A Retrospective Multicenter Study.

Simple SummaryWe aimed to investigate the relationship between the collapse of the vaginal cuff and the prognosis of TLRH. In this retrospective multicenter analysis, 94 early cervical cancer patients who underwent O-RH or TLRH in six hospitals in Japan between September 2016 and July 2020 were included; 36 patients underwent TLRH. PFS and OS were not significantly different between O-RH and TLRH groups. Tumor spillage was prevented by creating a vaginal cuff to avoid using a uterine manipulator. Therefore, TLRH might be considered efficient.Our goal was to compare the treatment outcomes of open-abdominal radical hysterectomy (O-RH) and total laparoscopic hysterectomy (TLRH) with vaginal cuff creation and without using a uterine manipulator in stage IB1-B2 (tumor size < 4 cm) cervical cancer cases. In this retrospective multicenter analysis, 94 cervical cancer stage IB1-B2 patients who underwent O-RH or TLRH in six hospitals in Japan between September 2016 and July 2020 were included; 36 patients underwent TLRH. Propensity score matching was performed because the tumor diameter was large, and positive cases of lymph node metastases were included in the O-RH group due to selection bias. The primary endpoint was progression-free survival (PFS) and recurrence sites of TLRH and O-RH. PFS and OS (overall survival) were not significant in both the TLRH (n = 27) and O-RH (n = 27) groups; none required conversion to laparotomy. The maximum tumor size was <2 and ≥2 cm in 12 (44.4%) and 15 (55.6%) patients, respectively, in both groups. Reportedly, the TLRH group had lesser bleeding than the O-RH group (p < 0.001). Median follow-up was 33.5 (2–65) and 41.5 (6–75) months in the TLRH and O-RH groups, respectively. PFS and OS were not significantly different between the two groups (TLRH: 92.6%, O-RH: 92.6%; log-rank p = 0.985 and 97.2%, 100%; p = 0.317, respectively). The prognosis of early cervical cancer was not significantly different between TLRH and O-RH. Tumor spillage was prevented by creating a vaginal cuff and avoiding the use of a uterine manipulator. Therefore, TLRH might be considered efficient.

Outcomes of laparoscopic radical hysterectomy in IA1- IB1 cervical cancer patients with low-risk: A multi-center retrospective study with 10 years’ experience (487)

<b>Objectives:</b> More evidence revealed that the oncological outcomes of open abdominal radical hysterectomy (OARH) were superior to those of laparoscopic radical hysterectomy (LRH) in patients with early-stage cervical cancer (CC). However, limited by the number of CC patients with IA and low-risk IB1, some aspects still needed more study to clarify. This retrospective study aimed to estimate the outcomes of LRH for IA1-IB1 cervical cancer patients with low- risk, which was defined as tumor <2cm, less than one-third stromal invasion, no lymphovascular space invasion (LVSI), no lymph node involvement. <b>Methods:</b> By carefully studying the results of the Laparoscopic Approach to Cervical Cancer (LACC) Trial, we were surprised to find that the number of early-stage CC patients with low risk was relatively insufficient. Therefore, we retrospectively reviewed the medical records to identify the low-risk patients with FIGO 2018 stage IA1, IA2, and IB1 cervical cancer and who received laparoscopic or abdominal radical hysterectomy from January 2010 to December 2020 at four hospitals. The Mann-Whitney U test and the Chi-square test were used for the comparison of categorical variables. Progression-free survival and overall survival were compared between matched groups using Kaplan-Meier survival analysis and log-rank tests, along with univariable and multivariable regression analysis. <b>Results:</b> Of 5360 patients selected, 1850 (35%) met the inclusion criteria for this study from January 2010 to December 2020. Of these, 1090 patients underwent open surgery, and 760 patients had laparoscopic surgery. In the entire cohort, the two groups were similar in regard to clinical characteristics, such as age, body mass index (BMI), FIGO stage, histologic type and grade, pelvic lymph nodes, positive margins, stromal invasion, LVSI, and adjuvant therapy. LRH had better outcomes compared with OARH in terms of blood loss, transfusion rates, and the length of hospital stay. And in the subgroup analysis, when it referred to those patients with low-risk factors (tumor <2cm, superficial stromal invasion, negative LVSI, and no lymph node involvement), the LRH group was equivalent to the OARH group with respect to both disease-free survival (DFS) and 5-year overall survival (OS) rates. What's more, when the tumor was >2cm or accompanied by other medium and high-risk factors, the LRH group showed a significantly shorter DFS and OS than OARH, which was consistent with the LACC Trial. <b>Conclusions:</b> Among FIGO 2018 stage IA1-IB1 CC patients with low- risk, tumor <2cm, superficial stromal invasion, negative LVSI, and no lymph node involvement, there was no detrimental effect on survival between LRH and OARH. And it also needed more prospective studies to explore the oncological outcomes of low-risk CC patients with stage IA1-IB1. Besides, LRH was closely associated with worse oncological outcomes than OARH in patients with risk factors.

Thirty-day Postoperative Adverse Events in Minimally Invasive versus Open Abdominal Radical Hysterectomy for Early-stage Cervical Cancer

To identify the incidence, type, and grade of postoperative adverse events in minimally invasive radical hysterectomy vs abdominal radical hysterectomy (ARH) for patients with early-stage cervical cancer and determine risk factors associated with these adverse events. The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) was queried to identify patients with early-stage cervical cancer undergoing radical hysterectomy. Multivariable logistic regression was used to assess risk factors associated with adverse postoperative outcomes among patients undergoing radical hysterectomy. ACS NSQIP participating institutions within the United States. Patients were collected from the ACS NSQIP databases (2014-2017) undergoing radical hysterectomy for early-stage cervical cancer. N/A MEASUREMENTS AND MAIN RESULTS: ARH had a significantly increased incidence of any 30-day postoperative adverse event compared with minimally invasive radical hysterectomy (31.2% vs 19.9%, p <.001). There was a higher incidence of surgical site infection, both deep and superficial, and blood transfusions in ARH. On multivariable logistic regression, the abdominal surgical approach was the only risk factor significantly associated with any postoperative adverse event (odds ratio, 1.4; confidence interval, 1.1-1.9; p=.018; 95% CIs). In this study, the abdominal surgical approach for radical hysterectomy in early-stage cervical cancer was associated with a higher incidence of postoperative adverse events than the minimally invasive approach.

Retrospective Analysis of Cervical Cancer Treatment Outcomes: Ten Years of Experience with the Vaginal Assisted Radical Laparoscopic Hysterectomy VARLH.

Background LACC trial demonstrated inferiority of laparoscopic approach for the treatment of early-stage cervical cancer. There are still limited data from retrospective trials regarding whether survival outcomes after laparoscopic radical hysterectomy are equivalent to those after open abdominal radical hysterectomy. In this study, we present results of combined vaginal radical laparoscopic hysterectomy in the treatment of early-stage cervical cancer. Methods This retrospective study was carried out at the Department of Gynecology in Mathilden Hospital (Herford, Germany). Between January 2008 and April 2018, all the patients with invasive cervical cancer who underwent combined vaginal assisted radical laparoscopic hysterectomy (VARLH) without the use of any uterine manipulator were enrolled to the study. Results A total number of 124 patients with diagnosis of invasive cervical cancer were enrolled in the study. All of the patients underwent minimally invasive surgery and were divided according to FIGO 2019: stage IA (25.9%), IB1 (25.0%), IB2-IIB (28.4%), and III/IV (20.7%). Overall, the mean age of the patients was 51.84 years. After a study collection, a median follow-up was 45.6 (range 23.7-76.5) months. The 3- and 5-year disease-free survival rates for early-stage cervical cancer were both 98%, and the 3- and 5-year overall survival rates were 100% and 97%, respectively. We have not observed any recurrence in our study group of patients with early-stage cervical cancer. Conclusions Combined VARLH can be considered a safe and effective procedure for the treatment of early-stage cervical cancer. Surgical strategy with oncological principles determines the quality and long-term success of the operation in early cervical cancer regardless of laparoscopic approach.

Does obesity influence the preferred treatment approach for early-stage cervical cancer? A cost-effectiveness analysis

<h3>Objectives:</h3> Obesity is a major public health concern and can have a negative impact on surgical outcomes. In 2018, a large, randomized control trial evaluated outcomes of minimally invasive radical hysterectomy (MIH) versus open abdominal radical hysterectomy (TAH) for treatment of early stage cervical cancer finding lower rates of disease free and overall survival in TAH. Regarding cost, previous studies have investigated outcomes and costs between MIH and TAH as well as between primary radiation and TAH, yet limited data exists on the outcomes and cost effectiveness of these treatments when compared among different body mass index (BMI) levels. The objective of this study was to examine how outcomes varied by BMI between treatment options for early stage cervical cancer and to ascertain which option was cost effective. <h3>Methods:</h3> A Markov decision analytic model was designed using TreeAge Pro software to compare the outcomes and costs of primary radiation versus surgery in women with stage IA1-IB1 cervical cancer. We used a theoretical cohort of 6,000 women who were definitively treated with either (1) TAH, (2) MIH, or (3) primary radiation therapy. We compared results for three BMI ranges: <30 kg/m², 30-39.9 kg/m², and ≥40 kg/m². Model inputs were derived from the literature and the model was run over a 5-year time period. Outcomes included complications, recurrence, death, costs, and quality-adjusted life years (QALYs). Sensitivity analyses were performed to determine the robustness of the results. An intervention was deemed cost effective with an incremental cost-effectiveness ratio (ICER) of less than $100,000 per QALY. <h3>Results:</h3> Among our cohort of 6,000 women with stage IA1-IB1 cervical cancer, TAH was associated with fewer cervical cancer recurrences and deaths compared to MIH; however, TAH resulted in more complications at each BMI level. Surgical complications outnumbered radiation-related complications as BMI increased. Recurrence rates were similar between TAH and radiation therapy, while there were more deaths associated with surgery. Comparing TAH to MIH, women with a BMI less than 30 had an ICER of $6,800 per QALY and women with a BMI 30-39.9 had an ICER of $739 per QALY. In women with a BMI ≥ 40, TAH was dominant. Comparing TAH to radiation therapy, women with a BMI less than 30 had an ICER of $191,000/QALY and women with a BMI 30-39.9 had an ICER of $133,000/QALY, which were not cost effective. In women with a BMI ≥ 40, the ICER was $88,000/QALY, making radiation therapy cost effective. <h3>Conclusions:</h3> Increasing BMI affects surgical morbidity as well as cost effectiveness of treatment modality for early stage cervical cancer. We found that at a BMI ≥ 40, TAH is both cost effective and provides cost savings when compared to MIH. When compared to primary radiation, TAH is cost effective at a BMI < 30 and 30-39.9. When the BMI is ≥ 40, primary radiation becomes cost-effective. This suggests that for women with early stage cervical cancer with the greatest BMI, primary radiation may be the optimal management strategy.

Total laparoscopic vs. conventional open abdominal nerve-sparing radical hysterectomy: clinical, surgical, oncological and functional outcomes in 301 patients with cervical cancer.

ObjectiveTotal laparoscopic nerve-sparing radical hysterectomy (TL-NSRH) has been considered a promising approach, however, surgical, clinical, oncological and functional outcomes have not been systematically addressed. We present a large retrospective multi-center experience comparing TL-NSRH vs. open abdominal NSRH (OA-NSRH) for early and locally-advanced cervical cancer, with particular emphasis on post-surgical pelvic function.MethodsAll consecutive patients who underwent class C1-NSRH plus bilateral pelvic + para-aortic lymphadenectomy for stage IA2–IIB cervical cancer at 4 Italian gynecologic oncologic centers (Negrar, Varese, Bologna, Avellino) were enrolled. Patients were divided into TL-NSRH and OA-NSRH groups and were investigated with preoperative questionnaires on urinary, rectal and sexual function. Postoperatively, patients filled a questionnaire assessing quality of life, taking into account sexual function and psychological status. Oncological outcomes were analyzed using Kaplan-Meyer method.Results301 consecutive patients were included in this study: 170 in the TL-NSRH group and 131 in the OA-NSRH group. Patients in the OA-NSRH group were more likely to experience urinary incontinence and (after 12-months follow-up) urinary retention. No patient in the TL-NSRH group vs. 5 (5.5%) in the OA-NSRH group had complete urinary retention (at the >24-month follow-up [p=0.02]). A total of 20 (11.8%) in the TL-NSRH and 11 (8.4%) patients in the OA-NSRH had recurrence of disease (p=0.44) and 14 (8.2%) and 9 (6.9%) died of disease during follow-up, respectively (p=0.83).ConclusionOur study shows that TL-NSRH is feasible, safe and effective and conjugates adequate radicality and improvement in post-operative functional outcomes. Oncological outcomes of laparoscopic procedures deserve further investigation.

Patterns of Recurrence after Laparoscopic and Open Abdominal Radical Hysterectomy for Cervical Cancer: A Propensity-Matched Analysis

Study Objective To identify different patterns of recurrence after laparoscopic and open abdominal radical hysterectomy for cervical cancer. Design This a retrospective multi-institutional study evaluating patients with recurrent cervical cancer after laparoscopic and open abdominal surgery. In order to reduce possible confounding factors, we applied a propensity-matching algorithm. Setting Two oncologic referral centers. Patients or Participants Consecutive cervical cancer patients who developed recurrence after surgical treatments. Interventions Laparoscopic and open abdominal radical hysterectomy. Measurements and Main Results Chart of 1,058 cervical cancer patients were retrieved. The study population included 117 (14.2%) and 35 (14.9%) patients with recurrent cervical cancer who had had open abdominal and laparoscopic surgery, respectively. Applying a propensity matched comparison (1:2) we reduced the study population to 105 patients (35 vs. 70 patients having recurrence after laparoscopic and open abdominal radical hysterectomy). The groups had similar baseline characteristics. Patients having laparoscopic radical hysterectomy experienced shorter progression-free survival than patients having open abdominal procedures (median progression-free survival: 8.0 vs. 15.8 months; HR: 1.98 (95%CI: 1.32 to 2.97); p=0.005). Site specific progression-free survival for vaginal, lymphatic and distant recurrences was similar between groups. However, patients having laparoscopy are at high risk of developing intra-pelvic recurrences and peritoneal carcinomatosis (HR: 17.9 (95%CI: 3.42 to 93.7); p=0.0006 log-rank test). Conclusion Patients having laparoscopy are at high risk of developing intra-pelvic recurrences and peritoneal carcinomatosis, due to unknown reasons (possibly due to a contamination of the pelvic area during colpotomy). Further evidence is needed in order to identify the best surgical treatment modality for cervical cancer patients.

867P Patterns of recurrence after minimally invasive and open abdominal radical hysterectomy for cervical cancer: A propensity-matched analysis

867P Patterns of recurrence after minimally invasive and open abdominal radical hysterectomy for cervical cancer: A propensity-matched analysis

SUCCOR study: an international European cohort observational study comparing minimally invasive surgery versus open abdominal radical hysterectomy in patients with stage IB1 cervical cancer

BackgroundMinimally invasive surgery in cervical cancer has demonstrated in recent publications worse outcomes than open surgery. The primary objective of the SUCCOR study, a European, multicenter, retrospective, observational cohort study...

Comparison of laparoscopic versus open radical hysterectomy in patients with early-stage cervical cancer: a multicenter study in China

IntroductionRecently, the safety of minimally invasive surgery in the treatment of cervical cancer has been questioned. This study was designed to compare the disease-free survival and overall survival of abdominal...

Postoperative comparison of laparoscopic radical resection and open abdominal radical hysterectomy for cervical cancer patient.

There are limited data regarding postoperative complications and autoimmune reactions caused by surgery in early-stage cervical cancer patients who underwent laparoscopic radical resection (LRR). This study aimed to investigate the therapeutic effect of LRR of cervical cancer patients and its effect on cytokines. 168 patients with cervical cancer were enrolled. The patients were divided into open group and laparoscopic group according to the random number table method, with 84 cases in each group. The surgical-related indexes and the incidence of complications of the two groups were observed, and the IFN-γ, TNF, and IL-1/2/4/6/8/10/12 levels in peripheral blood were compared before and after surgery in both groups. The operation time of the patients in the laparoscopic group was significantly shorter than that in the open group (119.56 ± 45.26 vs. 206.36 ± 54.39, P < 0.01). The intraoperative blood loss in the laparoscopic group was significantly less than that in the open group (155.29 ± 57.58 vs. 529.58 ± 162.4, P < 0.01). The postoperative visual analog scale (VAS) score was also significantly lower than that in the open group (3.65 ± 0.88 vs. 6.32 ± 1.12, P < 0.01). There was no significant difference in the incidence of complications between the two groups. The degree of inflammatory cytokines changes caused by LRR was less than that of open radical surgery (P < 0.001). LRR surgery has less stress on patients with early cervical cancer than open surgery within 5days after surgery, which has certain reference value for early cervical cancer treatment.

Patterns of recurrence after laparoscopic versus open abdominal radical hysterectomy in patients with cervical cancer: a propensity-matched analysis

ObjectiveRecent evidence has suggested that laparoscopic radical hysterectomy is associated with an increased risk of recurrence in comparison with open abdominal radical hysterectomy. The aim of our study was to...

Changing treatment landscape for early cervical cancer: outcomes reported with minimally invasive surgery compared with an open approach.

The aim of the article is to review recent studies that compare the oncologic efficacy of minimally invasive radical hysterectomy with that of open radical hysterectomy. The Laparoscopic Approach to Cervical Cancer (LACC) trial, a randomized study design to test the hypothesis that minimally invasive radical hysterectomy is not inferior to open radical hysterectomy, was stopped early by the data and safety monitoring committee after enrolling 631 of a planned 740 patients. The disease-free survival rate at 4.5 years was 86% among women assigned to minimally invasive surgery and 96.5% in those who underwent open surgery (hazard ratio [HR] 3.74; 95% confidence interval [CI] 1.63-8.58). Minimally invasive surgery was also associated with inferior overall survival (HR 6.00; 95% CI 1.44-12.7). Recent well designed, adequately powered observational studies mostly corroborate the findings of the LACC trial. After a decade of widespread acceptance and increasing popularity, the preponderance of evidence now suggests that minimally invasive radical hysterectomy for cervical cancer confers an excess risk of recurrence and death compared with open abdominal radical hysterectomy.

Laparoscopic vs. Open Abdominal Radical Hysterectomy for Cervical Cancer: A Single-Institution, Propensity Score Matching Study in China.

Study Objective: To compare the surgical and oncologic outcomes between open abdomen radical hysterectomy (ARH) and laparoscopic radical hysterectomy (LRH) for cervical cancer.Methods: Retrospective observational study with propensity score matching was used to ensure balanced groups for ARH and LRH. One-hundred-and-ninety-eight women with cervical cancer, 99 treated using ARH and 99 using LRH, between January 2012 and December 2014. Outcomes included disease-free survival (DFS), overall survival (OS), intra-operative factors, post-operator recovery, urinary retention, and adverse events. Moreover, the inverse probability of the treatment weighting (IPTW) method was also used.Main Results: Compared with ARH, LRH was associated with a lower volume of blood loss (P < 0.001) and transfusion rate (P < 0.001), with a broader resection of the parametrium (P < 0.001). Post-operatively, the time to first flatus was shorter for LRH than ARH (P < 0.001) but the rate of urinary retention was higher for LRH (22.2%) than ARH (8.1%; P = 0.009). DFS and OS were similar between groups. By IPTW, laparoscopy was also not associated with poorer survival in terms of DFS (HR 1.52, CI 0.799–2.891, P = 0.202) or OS (HR 0.942, HR 0.425–2.09, P = 0.883).Conclusion: Compared with ARH, LRH provided better intra-operative and post-operative outcomes, with no significant difference in oncologic outcomes and survival. Urinary retention remains a clinical issue to improve with LRH. The technology of LRH has been improved in China to address the inconsistent results of oncologic outcomes in previous studies. Whether these improvements could be effective needs to be investigated in the future.

The two Achilles heels of surgical randomized controlled trials: differences in surgical skills and reporting of average performance

Randomized controlled trials of surgery are fundamentally different from randomized controlled trials of medications because it is difficult to blind or mask a surgical procedure or perform "sham" operations. An additional challenge is the variation in skills and surgical proficiency of participating centers and surgeons. Addressing heterogeneity in surgical proficiency remains of paramount importance, especially when randomized controlled trials involve a new or complex procedure such as minimally invasive radical surgery. In the presence of such heterogeneity, it is very cumbersome to evaluate objectively and monitor surgical skills so that most trials simply report associations that are averaged across surgeons and hospitals/centers. Such reporting is not transparent because the rates of complications and adverse outcomes are reported only as averages, and these averages may not apply to the individual participating surgeons or centers. These factors, coupled with the inherent nongeneralizability of findings from such randomized controlled trials, because of the strict inclusion and exclusion criteria for enrollment, may lead to conclusions that no longer apply to real life for individual surgeons or centers. Case in point is a recently published noninferiority randomized controlled trial that reported that minimally invasive radical hysterectomy was associated with lower rates of disease-free survival (86% vs 96.5% at 4.5 years) and overall survival (93.8% vs 99% at 3 years) than open abdominal radical hysterectomy in patients with cervical cancer. However, randomized controlled trials that involve 2 competing complex or new procedures may be affected by tremendous confounding because of variations in surgical proficiency and also nonstandardization for other confounding factors such as patient selection categories (ie, stage of cancer) and adjuvant postoperative therapies that may affect long-term survival. The purpose of this Viewpoint is not to provide an exhaustive review of the trial's shortcomings but to use it as an illustration to focus on 2 challenging areas that most randomized controlled trials of a new complex surgical procedure suffer from: (1) unadjusting or not correcting for surgical skill variability and (2) nontransparent reporting of averaged results. We provide suggestions to overcome these deficiencies through robust methods and statistical approaches.

Interpretation and Implications of LACC Trial

LACC trial is a multicentre randomized controlled noninferiority trial. It evaluated the oncological outcomes after minimally invasive surgery and open abdominal radical hysterectomy among women with early-stage cervical cancer. The results showed lower disease-free survival (DFS) and overall survival (OS) in the minimally invasive surgery (MIS) arm. The results of the LACC trial were surprising and contrary to the outcomes in various other retrospective studies which compared outcomes in MIS and open arms for carcinoma cervix. We write this review article to rebut the LACC trial and point out few shortcomings of the trial. These may explain the outcomes. The surgeon proficiency criteria for MIS RH in the trial are inadequate. Surgeons were required to submit two unedited operative videos of MIS radical hysterectomy and outcomes of at least ten cases. The routine use of a uterine manipulator causes tumour fragmentation and is against the norms of oncosurgery. Missing histopathological data in almost a third of cases and inadequate follow-up data add to the lacunae. We think the inferior oncological outcomes in MIS arm are not due to MIS per se but due to these factors. Great caution is required in interpreting the results of the LACC trial. The authors of LACC trial mention that the results cannot be generalized to low-risk patients who still can undergo laparoscopic surgery. We recommend further trials to address the issue of safety of minimal access surgery in the treatment of early-stage carcinoma cervix. MIS radical hysterectomy can still be considered an oncologically safe treatment option in trained hands.

Minimally invasive surgery improves short-term outcomes of nerve-sparing radical hysterectomy in patients with cervical cancer: a propensity-matched analysis with open abdominal surgery.

ObjectivesNerve-sparing radical hysterectomy has been implemented in order to reduce pelvic floor dysfunctions in women undergoing radical surgery for cervical cancer. Here, we aimed to investigate if the adoption of laparoscopic surgery impacts on patients' outcomes.MethodsData of consecutive patients affected by cervical cancer who had laparoscopic nerve-sparing radical hysterectomy were matched 1:1 with an historical cohort of patients undergoing open procedure. A propensity-score matched algorithm was applied.ResultsThirty-five patients' pairs (70 patients: 35 undergoing laparoscopic vs. 35 undergoing open abdominal nerve-sparing radical hysterectomy) were included. Demographic and baseline oncologic characteristics were balanced between groups. Patients undergoing laparoscopic surgery had similar operative time than patients undergoing open abdominal procedures (249 [±91.5] vs. 223 [±65.0] minutes; p=0.066). Laparoscopic approach correlated with lower blood loss (30.5 [±11.0] vs. 190 [90.4] mL; p<0.001) and shorter hospital stay (3.2 [±1.2] vs. 5.4 [2.0] days; p=0.023). Patients undergoing laparoscopy experienced a lower 30-day pelvic floor dysfunction rate than patients having open surgery. Moreover, they experienced shorter recovery of bladder function than patients having open procedures (median, 7 vs. 9 days; p=0.004, log-rank test).ConclusionLaparoscopic approach resulted in a faster recovery of bladder function in comparison to open surgery for patients undergoing nerve-sparing radical hysterectomy.