Dataset Information

Incidence of adverse events in minimally invasive vs open radical hysterectomy in early cervical cancer: results of a randomized controlled trial.

ABSTRACT:

Background

Standard treatment of early cervical cancer involves a radical hysterectomy and retroperitoneal lymph node dissection. The existing evidence on the incidence of adverse events after minimally invasive vs open radical hysterectomy for early cervical cancer is either nonrandomized or retrospective.

Objective

The purpose of this study was to compare the incidence of adverse events after minimally invasive vs open radical hysterectomy for early cervical cancer.

Study design

The Laparoscopic Approach to Carcinoma of the Cervix trial was a multinational, randomized noninferiority trial that was conducted between 2008 and 2017, in which surgeons from 33 tertiary gynecologic cancer centers in 24 countries randomly assigned 631 women with International Federation of Gynecology and Obstetrics 2009 stage IA1 with lymph-vascular invasion to IB1 cervical cancer to undergo minimally invasive (n = 319) or open radical hysterectomy (n = 312). The Laparoscopic Approach to Carcinoma of the Cervix trial was suspended for enrolment in September 2017 because of an increased risk of recurrence and death in the minimally invasive surgery group. Here we report on a secondary outcome measure: the incidence of intra- and postoperative adverse events within 6 months after surgery.

Results

Of 631 randomly assigned patients, 536 (85%; mean age, 46.0 years) met inclusion criteria for this analysis; 279 (52%) underwent minimally invasive radical hysterectomy, and 257 (48%) underwent open radical hysterectomy. Of those, 300 (56%), 91 (16.9%), and 69 (12.8%) experienced at least 1 grade ?2 or ?3 or a serious adverse event, respectively. The incidence of intraoperative grade ?2 adverse events was 12% (34/279 patients) in the minimally invasive group vs 10% (26/257) in the open group (difference, 2.1%; 95% confidence interval, -3.3 to 7.4%; P=.45). The overall incidence of postoperative grade ?2 adverse events was 54% (152/279 patients) in the minimally invasive group vs 48% (124/257) in the open group (difference, 6.2%; 95% confidence interval, -2.2 to 14.7%; P=.14).

Conclusion

For early cervical cancer, the use of minimally invasive compared with open radical hysterectomy resulted in a similar overall incidence of intraoperative or postoperative adverse events.

SUBMITTER: Obermair A

PROVIDER: S-EPMC7181470 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Incidence of adverse events in minimally invasive vs open radical hysterectomy in early cervical cancer: results of a randomized controlled trial.

Obermair Andreas A Asher Rebecca R Pareja Rene R Frumovitz Michael M Lopez Aldo A Moretti-Marques Renato R Rendon Gabriel G Ribeiro Reitan R Tsunoda Audrey A Behan Vanessa V Buda Alessandro A Bernadini Marcus Q MQ Zhao Hongqin H Vieira Marcelo M Walker Joan J Spirtos Nick M NM Yao Shuzhong S Chetty Naven N Zhu Tao T Isla David D Tamura Mariano M Nicklin James J Robledo Kristy P KP Gebski Val V Coleman Robert L RL Salvo Gloria G Ramirez Pedro T PT

American journal of obstetrics and gynecology 20191003 3

<h4>Background</h4>Standard treatment of early cervical cancer involves a radical hysterectomy and retroperitoneal lymph node dissection. The existing evidence on the incidence of adverse events after minimally invasive vs open radical hysterectomy for early cervical cancer is either nonrandomized or retrospective.<h4>Objective</h4>The purpose of this study was to compare the incidence of adverse events after minimally invasive vs open radical hysterectomy for early cervical cancer.<h4>Study des ...[more]

PMID: 31586602

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Project description:Background: The comparison of survival outcomes between minimally invasive surgery and open surgery for cervical cancer patients remains controversial. We evaluated the survival outcomes of cervical cancer patients who underwent different surgical approaches. Methods: A literature search was performed in PubMed, Embase, and Cochrane databases up to February 2020, using the MESH terms "minimally invasive surgical procedures" and "Uterine Cervical Neoplasms." Included were all original comparative studies and trials both published and unpublished in English that were related to minimally invasive surgery and open surgery for cervical cancer patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage < IIB. Begg's and Egger's regressions were used to evaluate publication bias. Results: This meta-analysis included 28 studies enrolling 18,961 patients with cervical cancer. The overall analyses indicated that cervical cancer patients with FIGO 2009 stage < IIB who underwent minimally invasive surgery had a lower rate of OS (HR = 1.43, 95% CI = 1.06-1.92, P = 0.019) and DFS (HR = 1.50, 95% CI = 1.21-1.85, P < 0.001) than those who underwent open surgery. Moreover, minimally invasive surgery could lower OS (HR = 2.30, 95% CI = 1.50-3.52, P < 0.001) and DFS (HR = 1.94, 95% CI = 1.36-2.76, P < 0.001) of cervical cancer patients with FIGO 2009 stage ≤ IB1 compared to open surgery. However, there were no significant differences in OS (HR = 1.07, 95% CI = 0.65-1.76, P = 0.801) and DFS (HR = 1.20, 95% CI = 0.65-2.19, P = 0.559) in patients with tumors < 2 cm between the two groups. Conclusions: Minimally invasive radical hysterectomy was associated with poor survival outcomes compared to open surgery. Patients with FIGO 2009 stage ≤ IB1 cervical cancer who underwent minimally invasive surgery have lower OS and DFS rates than those who underwent open surgery. Therefore, open surgery should be performed for cervical cancer patients. However, patients with tumors < 2 cm might take the most advantage of minimally invasive surgery without increasing poor prognosis. There are some limitations in the meta-analysis, which needs further high-quality multicenter studies to confirm and update our findings.

Project description:ImportanceMinimally invasive techniques are increasingly common in cancer surgery. A recent randomized clinical trial has brought into question the safety of minimally invasive radical hysterectomy for cervical cancer.ObjectiveTo quantify the risk of recurrence and death associated with minimally invasive vs open radical hysterectomy for early-stage cervical cancer reported in observational studies optimized to control for confounding.Data sourcesOvid MEDLINE, Ovid Embase, PubMed, Scopus, and Web of Science (inception to March 26, 2020) performed in an academic medical setting.Study selectionIn this systematic review and meta-analysis, observational studies were abstracted that used survival analyses to compare outcomes after minimally invasive (laparoscopic or robot-assisted) and open radical hysterectomy in patients with early-stage (International Federation of Gynecology and Obstetrics 2009 stage IA1-IIA) cervical cancer. Study quality was assessed with the Newcastle-Ottawa Scale and included studies with scores of at least 7 points that controlled for confounding by tumor size or stage.Data extraction and synthesisThe Meta-analysis of Observational Studies in Epidemiology (MOOSE) checklist was used to abstract data independently by multiple observers. Random-effects models were used to pool associations and to analyze the association between surgical approach and oncologic outcomes.Main outcomes and measuresRisk of recurrence or death and risk of all-cause mortality.ResultsForty-nine studies were identified, of which 15 were included in the meta-analysis. Of 9499 patients who underwent radical hysterectomy, 49% (n = 4684) received minimally invasive surgery; of these, 57% (n = 2675) received robot-assisted laparoscopy. There were 530 recurrences and 451 deaths reported. The pooled hazard of recurrence or death was 71% higher among patients who underwent minimally invasive radical hysterectomy compared with those who underwent open surgery (hazard ratio [HR], 1.71; 95% CI, 1.36-2.15; P < .001), and the hazard of death was 56% higher (HR, 1.56; 95% CI, 1.16-2.11; P = .004). Heterogeneity of associations was low to moderate. No association was found between the prevalence of robot-assisted surgery and the magnitude of association between minimally invasive radical hysterectomy and hazard of recurrence or death (2.0% increase in the HR for each 10-percentage point increase in prevalence of robot-assisted surgery [95% CI, -3.4% to 7.7%]) or all-cause mortality (3.7% increase in the HR for each 10-percentage point increase in prevalence of robot-assisted surgery [95% CI, -4.5% to 12.6%]).Conclusions and relevanceThis systematic review and meta-analysis of observational studies found that among patients undergoing radical hysterectomy for early-stage cervical cancer, minimally invasive radical hysterectomy was associated with an elevated risk of recurrence and death compared with open surgery.

Project description:BackgroundMinimally invasive radical trachelectomy has emerged as an alternative to open radical hysterectomy for patients with early-stage cervical cancer desiring future fertility. Recent data suggest worse oncologic outcomes after minimally invasive radical hysterectomy than after open radical hysterectomy in stage I cervical cancer.ObjectiveWe aimed to compare 4.5-year disease-free survival after open vs minimally invasive radical trachelectomy.Study designThis was a collaborative, international retrospective study (International Radical Trachelectomy Assessment Study) of patients treated during 2005-2017 at 18 centers in 12 countries. Eligible patients had squamous carcinoma, adenocarcinoma, or adenosquamous carcinoma; had a preoperative tumor size of ≤2 cm; and underwent open or minimally invasive (robotic or laparoscopic) radical trachelectomy with nodal assessment (pelvic lymphadenectomy and/or sentinel lymph node biopsy). The exclusion criteria included neoadjuvant chemotherapy or preoperative pelvic radiotherapy, previous lymphadenectomy or pelvic retroperitoneal surgery, pregnancy, stage IA1 disease with lymphovascular space invasion, aborted trachelectomy (conversion to radical hysterectomy), or vaginal approach. Surgical approach, indication, and adjuvant therapy regimen were at the discretion of the treating institution. A total of 715 patients were entered into the study database. However, 69 patients were excluded, leaving 646 in the analysis. Endpoints were the 4.5-year disease-free survival rate (primary), 4.5-year overall survival rate (secondary), and recurrence rate (secondary). Kaplan-Meier methods were used to estimate disease-free survival and overall survival. A post hoc weighted analysis was performed, comparing the recurrence rates between surgical approaches, with open surgery being considered as standard and minimally invasive surgery as experimental.ResultsOf 646 patients, 358 underwent open surgery, and 288 underwent minimally invasive surgery. The median (range) patient age was 32 (20-42) years for open surgery vs 31 (18-45) years for minimally invasive surgery (P=.11). Median (range) pathologic tumor size was 15 (0-31) mm for open surgery and 12 (0.8-40) mm for minimally invasive surgery (P=.33). The rates of pelvic nodal involvement were 5.3% (19 of 358 patients) for open surgery and 4.9% (14 of 288 patients) for minimally invasive surgery (P=.81). Median (range) follow-up time was 5.5 (0.20-16.70) years for open surgery and 3.1 years (0.02-11.10) years for minimally invasive surgery (P<.001). At 4.5 years, 17 of 358 patients (4.7%) with open surgery and 18 of 288 patients (6.2%) with minimally invasive surgery had recurrence (P=.40). The 4.5-year disease-free survival rates were 94.3% (95% confidence interval, 91.6-97.0) for open surgery and 91.5% (95% confidence interval, 87.6-95.6) for minimally invasive surgery (log-rank P=.37). Post hoc propensity score analysis of recurrence risk showed no difference between surgical approaches (P=.42). At 4.5 years, there were 6 disease-related deaths (open surgery, 3; minimally invasive surgery, 3) (log-rank P=.49). The 4.5-year overall survival rates were 99.2% (95% confidence interval, 97.6-99.7) for open surgery and 99.0% (95% confidence interval, 79.0-99.8) for minimally invasive surgery.ConclusionThe 4.5-year disease-free survival rates did not differ between open radical trachelectomy and minimally invasive radical trachelectomy. However, recurrence rates in each group were low. Ongoing prospective studies of conservative management of early-stage cervical cancer may help guide future management.

Project description:BACKGROUND:Minimally invasive surgery was adopted as an alternative to laparotomy (open surgery) for radical hysterectomy in patients with early-stage cervical cancer before high-quality evidence regarding its effect on survival was available. We sought to determine the effect of minimally invasive surgery on all-cause mortality among women undergoing radical hysterectomy for cervical cancer. METHODS:We performed a cohort study involving women who underwent radical hysterectomy for stage IA2 or IB1 cervical cancer during the 2010-2013 period at Commission on Cancer-accredited hospitals in the United States. The study used inverse probability of treatment propensity-score weighting. We also conducted an interrupted time-series analysis involving women who underwent radical hysterectomy for cervical cancer during the 2000-2010 period, using the Surveillance, Epidemiology, and End Results program database. RESULTS:In the primary analysis, 1225 of 2461 women (49.8%) underwent minimally invasive surgery. Women treated with minimally invasive surgery were more often white, privately insured, and from ZIP Codes with higher socioeconomic status, had smaller, lower-grade tumors, and were more likely to have received a diagnosis later in the study period than women who underwent open surgery. Over a median follow-up of 45 months, the 4-year mortality was 9.1% among women who underwent minimally invasive surgery and 5.3% among those who underwent open surgery (hazard ratio, 1.65; 95% confidence interval [CI], 1.22 to 2.22; P=0.002 by the log-rank test). Before the adoption of minimally invasive radical hysterectomy (i.e., in the 2000-2006 period), the 4-year relative survival rate among women who underwent radical hysterectomy for cervical cancer remained stable (annual percentage change, 0.3%; 95% CI, -0.1 to 0.6). The adoption of minimally invasive surgery coincided with a decline in the 4-year relative survival rate of 0.8% (95% CI, 0.3 to 1.4) per year after 2006 (P=0.01 for change of trend). CONCLUSIONS:In an epidemiologic study, minimally invasive radical hysterectomy was associated with shorter overall survival than open surgery among women with stage IA2 or IB1 cervical carcinoma. (Funded by the National Cancer Institute and others.).

Project description:Cervical 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.A 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).Seventeen 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.The 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.

Project description:ObjectiveMinimally invasive radical hysterectomy (MIS-RH) for early-stage cervical cancer is a relatively new surgical procedure with increased utilization in the mid-/late-2000s. This study examined the association between hospital surgical volume for MIS-RH and perioperative outcomes for early-stage cervical cancer in the period of early adoption.MethodsThis population-based retrospective study queried the National Inpatient Sample from 2007 to 2011. Cervical cancer cases treated with MIS-RH were examined (n = 2202 from 163 hospitals). Annualized hospital surgical volume was defined as the average number of procedures performed per year in which at least one case was performed. Characteristics and outcomes related to MIS-RH use were assessed. The comparator cohort included RH by laparotomy (Open-RH; n = 11,187 from 405 hospitals).ResultsAmong MIS-RH-offering centers, 42.3% had average 1 case/year and surgical volume of >4 cases/year represented the top decile. When stratified by MIS-RH types, on average 31.3 centers performed robotic-assisted approach per year versus 11.5 centers for the traditional approach. Small bed capacity centers were most likely to perform robotic-assisted RH (adjusted-odds ratio 4.07, P < 0.001). In the traditional MIS-RH group, higher hospital surgical volume was associated with lower surgical morbidity (P = 0.025) whereas in the robotic-assisted approach higher hospital surgical volume was associated with higher surgical morbidity (P < 0.001). In the Open-RH cohort, higher hospital surgical volume was significantly associated with decreased surgical morbidity and mortality (both, P < 0.001).ConclusionIn the mid-/late-2000s, MIS-RH surgical volume was modest in the United States. Small bed capacity centers adopted robotic-assisted MIS-RH more frequently, and there was a statistically significant association of increased perioperative complications among higher volume centers. In contrast, higher surgical volume was associated with improved perioperative outcomes with the traditional MIS-RH and open-RH approaches.

Dataset Information

Incidence of adverse events in minimally invasive vs open radical hysterectomy in early cervical cancer: results of a randomized controlled trial.

Background

Objective

Study design

Results

Conclusion

Publications

Incidence of adverse events in minimally invasive vs open radical hysterectomy in early cervical cancer: results of a randomized controlled trial.

Similar Datasets

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