A phase III randomized clinical trial comparing laparoscopic radical hysterectomy based on open state with abdominal radical hysterectomy in patients with early-stage cervical cancer
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SUBMITTER: Zhao X
PROVIDER: S-EPMC11238402 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundThis study compared the survival outcomes of abdominal radical hysterectomy (ARH) (N = 32), laparoscopic radical hysterectomy (LRH) (N = 61), robot-assisted radical hysterectomy (RRH) (N = 100) and vaginal radical hysterectomy (VRH) (N = 45) approaches for early-stage cervical cancer to identify the surgical approach that provides the best survival.MethodsDisease-free survival (DFS) and overall survival (OS) were calculated using the Kaplan-Meier method, and survival curves were compared using the log-rank test.ResultsThe volume of intraoperative blood loss was greater in the ARH group than in the LRH group, the RRH group or the VRH group [(712.50 ± 407.59) vs. (224.43 ± 191.89), (109.80 ± 92.98) and (216.67 ± 176.78) ml, respectively; P < 0.001]. Total 5-year OS was significantly different among the four groups (ARH, 96.88%; LRH, 82.45%; RRH, 94.18%; VRH, 91.49%; P = 0.015). However, no significant difference in 5-year DFS was observed among the four groups (ARH, 96.88%; LRH, 81.99%; RRH, 91.38%; VRH, 87.27%; P = 0.061).ConclusionThis retrospective study demonstrated that ARH and RRH achieved higher 5-year OS rates than LRH for early-stage cervical cancer.
| S-EPMC10318649 | biostudies-literature
Project description:BackgroundSince the release of the LACC trial results in 2018, the safety of laparoscopic radical hysterectomy (LRH) for cervical cancer has received huge attention and heated discussion. We developed modified laparoscopic radical hysterectomy (MLRH) incorporating a series of measures to prevent tumor spillage, which has been performed in our center since 2015.ObjectivePresent study retrospectively analyzed relevant indicators of MLRH and evaluated disease-free survival (DFS) primarily in the treatment of early cervical cancer compared with open surgery.MethodsPatients with 2014 International Federation of Gynecology and Obstetrics clinical stages 1B1 and 2A1 cervical cancer who underwent radical hysterectomy in the gynecological department of our hospital from October 2015 to June 2018 were enrolled retrospectively in this study. Patients were divided into two groups based on the surgical procedure: open radical hysterectomy (ORH) group (n = 336) and MLRH group (n = 302). Clinical characteristics, surgical indices, and survival prognosis were analyzed, including 2.5-year overall survival (OS) rate, 2.5-year DFS rate, recurrence rate, and recurrence pattern.ResultsCompared to the ORH group, the MLRH group exhibited a longer operative time, longer 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 OS, 2.5-year DFS, and recurrence rate between the two groups (P > 0.05); however, the recurrence pattern was significantly different (P < 0.05). The MLRH group mainly exhibited local single metastasis (7/11), whereas the ORH group mainly exhibited distant multiple metastases (14/16). Stratified analysis revealed that overall survival rate was higher in the MLRH group than in the ORH group in patients with stage 1B1 and middle invasion (P < 0.05).ConclusionMLRH does not show a survival disadvantage in the treatment of early-stage cervical cancer when compared with open surgery. In addition, MLRH shows a survival advantage in patients with stage 1B1 and middle 1/3 invasion. Considering this is a retrospective study, further prospective study is necessary for more sufficient data support.Trial registrationPresent 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.
| S-EPMC9743762 | biostudies-literature
Project description:Recent evidence has shown an increase in recurrence and a decrease in overall survival in patients treated with laparoscopic radical hysterectomy (LRH) and robotic assisted radical hysterectomy (RRH) open techniques (ORH). In addition, several high quality trials were recently published regarding the laparoscopic treatment of early stage cervical cancer. We sought out to reassess the recurrence rates, overall survival, complications and outcomes associated with laparoscopic radical hysterectomy (LRH) techniques against open techniques (ORH) when robotic assisted techniques were excluded. We searched PubMed, Medline, Cochrane CENTRAL, SCOPUS, ClinicalTrials.Gov and Web of Science for relevant clinical trials and observational studies. We included all studies that compared with early stage cervical cancer receiving LRH compared with ORH. We included randomized clinical trials, prospective cohort, and retrospective cohort trials. We included studies that included LRH and RRH as long as data was available to separate the two arms. We excluded studies that combined LRH and RRH without supplying data to differentiate. Of 1244 total studies, we used a manual three step screening process. Sixty studies ultimately met our criteria. We performed this review in accordance with PRISMA guidelines. We analyzed continuous data using mean difference (MD) and a 95% confidence interval (CI), while dichotomous data were analyzed using odds ratio (OR) and a 95% CI. Review Manager and Endnote software were utilized in the synthesis. We found that when excluding RRH, the was no significant difference regarding 5-year overall Survival (OR = 1.24 [0.94, 1.64], (P = 0.12), disease free survival (OR = 1.00 [0.80, 1.26], (P = 0.98), recurrence (OR = 1.01 [0.81, 1.25], (P = 0.95), or intraoperative complications (OR = 1.38 [0.94, 2.04], (P = 0.10). LRH was statistically better than ORH in terms of estimated blood loss (MD = - 325.55 [- 386.16, - 264.94] (P < 0.001), blood transfusion rate (OR = 0.28 [0.14, 0.55], (P = 0.002), postoperative complication rate (OR = 0.70 [0.55, 0.90], (P = 0.005), and length of hospital stay (MD = - 3.64[- 4.27, - 3.01], (P < 0.001). ORH was superior in terms of operating time (MD = 20.48 [8.62, 32.35], (P = 0.007) and number of resected lymph nodes (MD = - 2.80 [- 4.35, - 1.24], (P = 0.004). The previously seen increase recurrence and decrease in survival is not seen in LRH when robotic assisted techniques are included and all new high quality is considered. LRH is also associated with a significantly shorter hospital stay, less blood loss and lower complication rate.Prospero Prospective Registration Number: CRD42022267138.
| S-EPMC9822966 | biostudies-literature
Project description:This study is to compare the survival outcomes of laparoscopic radical hysterectomy (LRH) to those of abdominal radical hysterectomy (ARH) for patients with locally advanced cervical cancer (LACC). Patients with the International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IB2 to IIB LACC who underwent radical hysterectomy between 2001 and 2015 were identified. The disease-free survival (DFS) and overall survival (OS) were compared according to the surgical approach and were adjusted based on clinicopathologic characteristics. A total of 396 patients were included in the study, with 179 (45.2%) and 217 (54.8%) patients in the ARH and LRH groups, respectively. The LRH group showed a significantly lower amount of estimated blood loss, lower blood transfusion rate and shorter length of hospital stay. Overall, there were no significant differences in the 5-year DFS and 5-year OS between the LRH and ARH groups with the Kaplan-Meier method. However, multivariate analyses identified LRH as an independent prognostic factor for a poor DFS (hazard ratio [HR] 2.5; 95% confidence interval [95% CI] 0.19 to 0.87; p = 0.02). The analysis of stage IB2 disease and the squamous subtype (61.9% and 87.9% of all participants, respectively) reached the same conclusion. When stratifying by FIGO stage, the patients with IB2 (n = 348) in the ARH group had a significantly better DFS (HR 0.14, 95% CI 0.05-0.42, p < 0.01) and OS (HR 0.17, 95% CI 0.04-0.67, p = 0.11) than those in the LRH group in the Cox regression model. However, no differences were found in patient with stage IIA1, IIA2, or IIB in Cox regression model. When stratifying by histological types, for the patients with squamous carcinomas (n = 375), in Cox model, ARH had a significantly superior DFS compared with those who underwent LRH (HR 0.45, 95% CI 0.25-0.82, p = 0.01), but the OS was not statistically significant (HR 0.57, 95% CI 0.27-1.20, p = 0.14). However, no differences were found in patient with adenocarcinoma and adenosquamous carcinomas in the Cox model. Therefore, ARH was associated with a higher DFS than LRH in patients with LACC, especially in patients with stage IB2 disease or the squamous subtype.
| S-EPMC6890871 | biostudies-literature
Project description:ObjectiveCervical cancer (CC) continues to be a global burden for women, with higher incidence and mortality rates reported annually. Many countries have witnessed a dramatic reduction in the prevalence of CC due to widely accessed robotic radical hysterectomy (RRH). This network meta-analysis aims to compare intraoperative and postoperative outcomes in way of RRH, laparoscopic radical hysterectomy (LTH) and open radical hysterectomy (ORH) in the treatment of early-stage CC.MethodsA comprehensive search of PubMed, Cochrane Library and EMBASE databases was performed from inception to June 2016. Clinical controlled trials (CCTs) of above three hysterectomies in the treatment of early-stage CC were included in this study. Direct and indirect evidence were incorporated for calculating values of weighted mean difference (WMD) or odds ratio (OR), and drawing the surface under the cumulative ranking curve (SUCRA).ResultsSeventeen 17 CCTs were ultimately enrolled in this network meta-analysis. The network meta-analysis showed that patients treated by RRH and LRH had lower estimated blood loss compared to patients treated by ORH (WMD = -399.52, 95% CI = -600.64~-204.78; WMD = -277.86, 95%CI = -430.84 ~ -126.07, respectively). Patients treated by RRH and LRH had less hospital stay (days) than those by ORH (WMD = -3.49, 95% CI = -5.79~-1.24; WMD = -3.26, 95% CI = -5.04~-1.44, respectively). Compared with ORH, patients treated with RRH had lower postoperative complications (OR = 0.21, 95%CI = 0.08~0.65). Furthermore, the SUCRA value of three radical hysterectomies showed that patients receiving RRH illustrated better conditions on intraoperative blood loss, operation time, the number of resected lymph nodes, length of hospital stay and intraoperative and postoperative complications, while patients receiving ORH demonstrated relatively poorer conditions.ConclusionThe results of this meta-analysis confirmed that early-stage CC patients treated by RRH were superior to patients treated by LRH and ORH in intraoperative blood loss, length of hospital stay and intraoperative and postoperative complications, and RRH might be regarded as a safe and effective therapeutic procedure for the management of CC.
| S-EPMC5858845 | biostudies-literature
Project description: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.
| S-EPMC6833183 | biostudies-literature
Project description:BackgroundPrevious studies have reported the safety of laparoscopic radical hysterectomy for treatment of early cervical cancer, as option to laparotomy. This study aims to compare overall survival between laparoscopic versus abdominal radical hysterectomy for early cervical cancer.MethodsA single-center randomized controlled trial enrolled 30 patients with clinically staged IA2 cervical cancer and lymphovascular invasion, IB and IIA, who underwent laparoscopic radical hysterectomy (16) or abdominal radical hysterectomy (14).ResultThe mean overall survival time was 74.74 months (CI 95%: 54.15-95.33) for LRH 91.67 months (CI 95%: 74.97-108.37) for ARH (log-rank test = 0.30). The mean disease-free survival time was 81.07 months (CI 95%: 60.95-101.19) for LRH and 95.82 months (CI 95%: 80.18-111.47) for ARH (log-rank test = 0.371). The overall survival hazard ratio was 2.05 (CI 95%: 0.51-8.24), and the disease-free hazard ratio was 2.13 (CI 95%: 0.39-11.7).ConclusionOur study suggests a non-significant trend of worse outcomes for LRH. In light of recent controversy and need for prospective studies, further studies in different populations are required for definite conclusions and until then, patients should be aware of risks and benefits, survival data and quality of life outcomes related to both surgical techniques.
| S-EPMC8184196 | biostudies-literature
Project description:PurposeDespite the benefits of minimally invasive surgery for cervical cancer, there are a lack of randomized trials comparing laparoscopic radical hysterectomy and abdominal radical hysterectomy. We compared morbidity, cost of care, and survival between abdominal radical hysterectomy and laparoscopic radical hysterectomy for cervical cancer.Materials and methodsWe used the Korean nationwide database to identify women with cervical cancer who underwent radical hysterectomy from January 1, 2011 to December 31, 2014. Patients who underwent abdominal radical hysterectomy were compared to those who underwent laparoscopic radical hysterectomy. Perioperative morbidity, the use of adjuvant therapy, and survival were evaluated after propensity score balancing.ResultsWe identified 6,335 patients, including 3,235 who underwent abdominal radical hysterectomy and 3,100 who underwent laparoscopic radical hysterectomy. The use of laparoscopic radical hysterectomy increased from 46.1% in 2011 to 51.8% in 2014. Patients who were younger, had a more recent year of diagnosis, and were treated in the metropolitan area were more likely to undergo a laparoscopic procedure (p < 0.001). Compared to abdominal radical hysterectomy, laparoscopic radical hysterectomy was associated with lower rates of complication, fewertransfusions, a shorter hospital stay, less adjuvant therapy, and reduced total medical costs (p < 0.001). Laparoscopic surgery was associated with a better overall survival than abdominal operation (hazard ratio, 0.74; 95% confidence interval, 0.64 to 0.85).ConclusionIn the postdissemination era, laparoscopic radical hysterectomy was associated with more favorable morbidity profiles, a lower cost of care, and comparable survival than abdominal radical hysterectomy.
| S-EPMC6473278 | biostudies-literature
Project description:BackgroundLaparoscopic 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.MethodsTwo 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.ResultsFourteen 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).ConclusionsLRH 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.
| S-EPMC9624383 | biostudies-literature
Project description:Non-randomised studies have suggested that the postoperative complications of (Campos LS, Limberger LF, Stein AT, Kalil AN) laparoscopic radical hysterectomy are similar to those in abdominal radical hysterectomy. However, no study evaluating postoperative pain comparing both techniques has been published thus far. Our objective was to compare pain intensity and other perioperative outcomes between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in early cervical cancer.This single centre, randomised, controlled trial enrolled 30 cervical cancer patients who were clinically staged IA2 with lymph vascular invasion and IB according to the FIGO (International Federation of Gynaecology and Obstetrics) classification, and underwent LRH or ARH between late 1999 and early 2004. Postoperative pain, as measured by a 10-point numerical rate scale, was considered the primary endpoint. Postoperative pain was assessed every six hours during a patient's usual postoperative care. Perioperative outcomes were also registered. Both surgical techniques were executed by the same surgical team. Secondary outcomes included intraoperative and other postoperative surgicopathological factors and 5-year survival rates.IA2 patients with lymphatic vascular space invasion and IB cervical cancer patients were randomised to either the LRH group (16 patients) or the ARH group (14 patients). Four patients (25%) in the LRH group and 5 patients (36%) in the ARH group presented with transoperative or serious postoperative complications. All of the transoperative complications occurred in the LRH group. The relative risk of presenting with complications was 0.70; CI 95% (0.23-2.11); P?=?0.694. LRH group mean pain score was significantly lower than ARH after 36 h of observation (P?=?0.044; mean difference score: 1.42; 95% CI: 0.04-2.80). The survival results will be published elsewhere.LRH provided lower pain scores after 36 h of observation in this series. The perioperative and serious postoperative complications ratios were comparable between the groups.NCT01258413.
| S-EPMC3856515 | biostudies-literature