scholarly journals Efficacy of different surgical approaches on survival outcomes in patients with early-stage cervical cancer: protocol for a multicentre longitudinal study in China

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e038020
Author(s):  
Xiaopei Chao ◽  
Ming Wu ◽  
Shuiqing Ma ◽  
Xianjie Tan ◽  
Sen Zhong ◽  
...  

IntroductionRecent studies have revealed that the oncological survival outcomes of minimally invasive radical hysterectomy (MIRH) are inferior to those of abdominal radical hysterectomy (ARH) in early-stage cervical cancer, but the potential reasons are unclear.Methods and analysisEach expert from 28 study centres participating in a previously reported randomised controlled trial (NCT03739944) will provide successive eligible records of at least 100 patients who accepted radical hysterectomy for early-stage cervical cancer between 1 January 2009 and 31 December 2015. Inclusion criteria consist of a definite pathological evaluation of stages IA1 (with positive lymphovascular space invasion), IA2 and IB1 according to the International Federation of Gynecology and Obstetrics 2009 staging system and a histological subtype of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma. The primary endpoint is 5-year disease-free survival between the MIRH and ARH groups. The secondary endpoints include the MIRH learning curves of participating surgeons, 5-year overall survival between the MIRH and ARH groups, survival outcomes according to surgical chronology, surgical outcomes and sites of recurrence and potential risk factors that affect survival outcomes. A subgroup analysis in patients with tumour diameter less than 2 cm will follow the similar flow diagram.Ethics and disseminationThis study has been approved by the Institutional Review Board of Peking Union Medical College Hospital (registration no. JS-1711), and is also filed on record by all other 27 centres. The results will be disseminated through community events and peer-reviewed journals.Trial registration numberNCT03738969


2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Seracchioli Renato ◽  
Mabrouk Mohamed ◽  
Solfrini Serena ◽  
Montanari Giulia ◽  
Ferrini Giulia ◽  
...  

Robot-assisted procedures are being increasingly incorporated in gynaecologic oncology. Several studies have confirmed the feasibility and safety of robotic radical hysterectomy for selected patients with early-stage cervical cancer. It has been demonstrated that robotic radical hysterectomy offers an advantage over other surgical approaches with regard to operative time, blood loss, and hospital stay. Also initial evidences concerning oncological outcomes seem to confirm the equivalence to traditional open technique. Despite the fact that costs of robotic system are still high, they could be partially offset by several health-related and social benefits: less pain, faster dismissal, and return to full activity than other surgical approaches. The development of robotic technology may facilitate the spread of minimally invasive surgery in gynaecological oncology, overcoming some drawbacks of laparoscopic technique for challenging intervention such as radical hysterectomy. Further studies are needed to evaluate overall and disease-free survival of this technique and associated morbidity after adjuvant therapies.



2021 ◽  
Author(s):  
Xuqing Li ◽  
Xueting Pei ◽  
Hongyan Li ◽  
Yan Wang ◽  
Youwei Zhou ◽  
...  

Abstract Background: To investigate the safety and efficacy of modified laparoscopic radical hysterectomy (MLRH) in the treatment of early stage cervical cancer by comparing relevant indices of different surgical procedures in patients with early stage cervical cancer.Methods: Patients with 2014 International Federation of Gynecology and Obstetrics (FIGO) clinical stages IB1 and IIA1 cervical cancer who underwent radical hysterectomy in the Gynecological Department of our hospital from October 2015 to June 2018 were enrolled. Patients were divided into two groups based on the surgical procedure: the open radical hysterectomy (ORH) group (n=336) and MLRH group (n=302). We retrospectively analyzed and compared the clinical characteristics, surgical indices, and survival prognosis between the groups.Results: Compared to the ORH group, the MLRH group exhibited a longer operative time, normal bladder function recovery time, less intraoperative blood loss volume, and more harvested pelvic lymph nodes (P<0.05). No significant differences were observed in postoperative complications, the 2.5-year overall survival (OS) rate, 2.5-year disease-free survival (DFS) rate, and recurrence rate between the groups (P>0.05), but the recurrence pattern was significantly different between the groups (P<0.05). Stratified analysis revealed that OS time was shorter in the ORH group than in the MLRH group in patients with stage IB1 and middle invasion (P<0.05). Pathological type was an independent factor for DFS and OS in early stage cervical cancer.Conclusion: MLRH incorporates a series of measures to prevent tumor spillage. It is a feasible and effective surgical procedure for the treatment of early stage cervical cancer.Trial registration: Present research is a retrospective study. The study had retrospectively registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn/) and the registered number is ChiCTR1900026306.



BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e029055 ◽  
Author(s):  
Xiaopei Chao ◽  
Lei Li ◽  
Ming Wu ◽  
Shuiqing Ma ◽  
Xianjie Tan ◽  
...  

IntroductionIn the last three decades, minimally invasive surgery (MIS) for radical hysterectomy (RH) has become a popular treatment option for early-stage cervical cancer. However, a recently published randomised controlled trial (LACC trial) and an epidemiological study in the USA revealed strong evidence against the survival advantage of MIS for RH. However, the influencing factors of research centres and the learning curves of surgeons in these studies lacked sufficient evaluation. The efficacy of different surgical approaches for early-stage cervical cancer in the clinical and survival outcomes remains to be validated.Methods and analysisPatients diagnosed with FIGO (2009) stage IA1 (with lymphovascular space invasion), IA2 or IB1 cervical cancer with histological subtype of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma will be recruited in this multicentre randomised controlled study. Patients will be randomly assigned to undergo MIS (robot-assisted or laparoscopic RH) or abdominal RH. Within 2 years, 1448 patients in 28 centres in China will be recruited to meet the criteria of a non-inferiority threshold of HR of 1.6 with bilateral nominal α <0.05 and power of 0.8. All surgeries will be performed by the indicated experienced surgeons. At least 100 RH cases in the individual past one decade of practice will be analysed as proof of learning curves. The primary objective of this study is 5-year disease-free survival. The secondary objectives include the overall survival rate, progression-free survival rate, disease-free survival rate, cost-effectiveness and quality of life.Ethics and disseminationThis study has been approved by the Institutional Review Board of Peking Union Medical College Hospital and is filed on record by all other centres. Written informed consent will be obtained from all eligible participants before enrolment. The results will be disseminated through community events, academic conferences, student theses and peer-reviewed journals.Trial registration numberNCT03739944.



2021 ◽  
pp. ijgc-2020-002086
Author(s):  
Juliana Rodriguez ◽  
Jose Alejandro Rauh-Hain ◽  
James Saenz ◽  
David Ortiz Isla ◽  
Gabriel Jaime Rendon Pereira ◽  
...  

IntroductionRecent evidence has shown adverse oncological outcomes when minimally invasive surgery is used in early-stage cervical cancer. The objective of this study was to compare disease-free survival in patients that had undergone radical hysterectomy and pelvic lymphadenectomy, either by laparoscopy or laparotomy.MethodsWe performed a multicenter, retrospective cohort study of patients with cervical cancer stage IA1 with lymph-vascular invasion, IA2, and IB1 (FIGO 2009 classification), between January 1, 2006 to December 31, 2017, at seven cancer centers from six countries. We included squamous, adenocarcinoma, and adenosquamous histologies. We used an inverse probability of treatment weighting based on propensity score to construct a weighted cohort of women, including predictor variables selected a priori with the possibility of confounding the relationship between the surgical approach and survival. We estimated the HR for all-cause mortality after radical hysterectomy with weighted Cox proportional hazard models.ResultsA total of 1379 patients were included in the final analysis, with 681 (49.4%) operated by laparoscopy and 698 (50.6%) by laparotomy. There were no differences regarding the surgical approach in the rates of positive vaginal margins, deep stromal invasion, and lymphovascular space invasion. Median follow-up was 52.1 months (range, 0.8–201.2) in the laparoscopic group and 52.6 months (range, 0.4–166.6) in the laparotomy group. Women who underwent laparoscopic radical hysterectomy had a lower rate of disease-free survival compared with the laparotomy group (4-year rate, 88.7% vs 93.0%; HR for recurrence or death from cervical cancer 1.64; 95% CI 1.09–2.46; P=0.02). In sensitivity analyzes, after adjustment for adjuvant treatment, radical hysterectomy by laparoscopy compared with laparotomy was associated with increased hazards of recurrence or death from cervical cancer (HR 1.7; 95% CI 1.13 to 2.57; P=0.01) and death for any cause (HR 2.14; 95% CI 1.05–4.37; P=0.03).ConclusionIn this retrospective multicenter study, laparoscopy was associated with worse disease-free survival, compared to laparotomy.



2019 ◽  
Vol 79 (02) ◽  
pp. 145-147 ◽  
Author(s):  
Peter Hillemanns ◽  
Sara Brucker ◽  
Bernd Holthaus ◽  
Rainer Kimmig ◽  
Björn Lampe ◽  
...  

AbstractIn this opinion on the randomized study comparing minimally invasive with abdominal radical hysterectomy for early-stage cervical cancer (LACC), the Uterus Commission of the Gynecological Oncology Working Group (AGO) and the Gynecological Endoscopy Working Group (AGE) of the Germany Society of Gynecology and Obstetrics (DGGG) state that, based on their examination of the published data, patients with FIGO stage IA1 (with LVSI), IA2 or IB1 cervical cancer must be informed about the results of this LACC study prior to making a decision on the route for radical hysterectomy.



2022 ◽  
Vol 2022 ◽  
pp. 1-10
Author(s):  
R. Wojdat ◽  
E. Malanowska

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.



2021 ◽  
Vol 11 ◽  
Author(s):  
Ying Yang ◽  
Yue Huang ◽  
Zhengyu Li

PurposeTo compare the clinical outcomes of patients with early-stage cervical cancer who underwent minimally invasive surgery (MIS) by surgeons in different phases and evaluate whether the proficiency of surgeons affects the survival outcomes.Materials and MethodsA total of 851 patients with early-stage cervical cancer who underwent radical hysterectomy between January 2008 and June 2018 (every year from January to June) at a tertiary hospital were retrospectively analyzed. We categorized patients into four phases according to their sequence (phase one, 1-10 cases; phase two: 11-20 cases; phase three: 21-30 cases; phase four: &gt; 30 cases). Demographics and clinical and pathological data were collected and analyzed.ResultsThere were no statistical differences between the open surgery and MIS groups regarding three- and five-year overall survival (OS) and disease-free survival (DFS). The OS and DFS of patients in the MIS group in phase one were significantly lower than those in later phases and those in the open surgery group after adjustment (OS, P = 0.009; HR, 2.896; 95%CI, 1.303-6.435; DFS, P = 0.009; HR, 2.712; 95%CI, 1.289-5.706). Survival outcomes were not statistically significant when comparing different surgeons.ConclusionThe phase one cases of MIS had lower OS and DFS than those in later phases and those in the open surgery group. Thus, we suggest that the proficiency of surgeons is associated with survival outcomes of MIS. Favorable outcomes can be obtained after a certain number of MIS cases.



2020 ◽  
Vol 30 (8) ◽  
pp. 1143-1150
Author(s):  
Ting wen yi Hu ◽  
Yue Huang ◽  
Na Li ◽  
Dan Nie ◽  
Zhengyu Li

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 radical hysterectomy and laparoscopic radical hysterectomy in patients with early-stage cervical cancer.MethodsA total of 1065 patients with early-stage cervical cancer who had undergone abdominal/laparoscopic radical hysterectomy between January 2013 and December 2016 in seven hospitals were retrospectively analyzed. The 1:1 propensity score matching was performed in all patients. Patients with tumor size ≥2 cm and <2 cm were stratified and analyzed separately. Disease-free survival and overall survival were compared between matched groups. After confirming the normality by the Shapiro-Wilks test, the Mann-Whitney U test and the χ2 test were used for the comparison of continuous and categorical variables, respectively. The survival curves were generated by the Kaplan-Meier method and compared by log-rank test.ResultsAfter matching, a total of 812 patients were included in the disease-free survival and overall survival analyses. In the entire cohort, the laparoscopic radical hysterectomy group had a significantly shorter disease-free survival (HR 1.65, 95% CI 1.00 to 2.73; p=0.048) but not overall survival (HR 1.60, 95% CI 0.89 to 2.88; p=0.12) when compared with the abdominal radical hysterectomy group. In patients with tumor size ≥2 cm, the laparoscopic radical hysterectomy group had a significantly shorter disease-free survival (HR 1.93, 95% CI 1.05 to 3.55; p=0.032) than the abdominal radical hysterectomy group, whereas no significant difference in overall survival (HR 1.90, 95% CI 0.95 to 3.83; p=0.10) was found. Additionally, in patients with tumor size <2 cm, the laparoscopic radical hysterectomy and abdominal radical hysterectomy groups had similar disease-free survival (HR 0.71, 95% CI 0.24 to 2.16; p=0.59) and overall survival (HR 0.59, 95% CI 0.11 to 3.13; p=0.53).ConclusionLaparoscopic radical hysterectomy was associated with inferior disease-free survival compared with abdominal radical hysterectomy in the entire cohort, as well as in patients with tumor size ≥2 cm. For the surgical treatment of patients with early-stage cervical cancer, priority should be given to open abdominal radical hysterectomy.



2020 ◽  
Vol 156 (3) ◽  
pp. 591-597 ◽  
Author(s):  
Benny Brandt ◽  
Vasileios Sioulas ◽  
Derman Basaran ◽  
Theresa Kuhn ◽  
Katherine LaVigne ◽  
...  


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