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Comparative effectiveness of laparoscopy vs open colectomy among nonmetastatic colon cancer patients: an analysis using the National Cancer Data Base.

ABSTRACT: Randomized clinical trials showed that laparoscopic colectomy (LC) is superior to open colectomy (OC) in short-term surgical outcomes; however, the generalizability among real-world patients is not clear. The National Cancer Data Base was used to identify stage I-III colon cancer patients age 18 to 84 years in 2010 and 2011. A propensity score analysis with 1:1 matching (PS) was used to avoid the effect of treatment selection bias. Patients were clustered at the hospital level for multilevel regression analyses. The main outcomes measured were 30-day mortality, unplanned readmissions, length of stay (LOS), and initiation of adjuvant chemotherapy among stage III patients. All statistical tests were two-sided. A total of 45 876 patients were analyzed, 18 717 (41%) LC and 27 159 (59%) OC. After PS matching, there were 18 230 patients in both groups and they were well balanced on their covariables. Compared with OC, LC showed consistent benefits in 30-day mortality (1.3% vs 2.3 %, odds ratio [OR] = 0.59, 95% confidence interval [CI] = 0.49 to 0.69, P < .001) and LOS (median 5 vs 6 days, incident rate ratio = 0.83, 95% CI = 0.8 to 0.84, P < .001). LC was also associated with a higher rate of adjuvant chemotherapy use in stage III patients (72.3% vs 67.0%, P < .001). LC was more likely to be performed by high-volume surgeons in high-volume hospitals, but there was no significant effect of the hospital/surgeon volume on short-term outcomes. In routine clinical practice, laparoscopic colectomy is associated with lower 30-day mortality, shorter length of stay, and greater likelihood of adjuvant chemotherapy initiation among stage III colon cancer patients when compared with open colectomy.

SUBMITTER: Zheng Z

PROVIDER: S-EPMC4565531 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature

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Comparative effectiveness of laparoscopy vs open colectomy among nonmetastatic colon cancer patients: an analysis using the National Cancer Data Base.

Zheng Zhiyuan Z Jemal Ahmedin A Lin Chun Chieh CC Hu Chung-Yuan CY Chang George J GJ

Journal of the National Cancer Institute 20150206 3

<h4>Background</h4>Randomized clinical trials showed that laparoscopic colectomy (LC) is superior to open colectomy (OC) in short-term surgical outcomes; however, the generalizability among real-world patients is not clear.<h4>Methods</h4>The National Cancer Data Base was used to identify stage I-III colon cancer patients age 18 to 84 years in 2010 and 2011. A propensity score analysis with 1:1 matching (PS) was used to avoid the effect of treatment selection bias. Patients were clustered at the ...[more]

PMID: 25663688

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Project description:ImportanceTemporal shifts in clinical knowledge and practice need to be adjusted for in treatment outcome assessment in clinical evidence.ObjectiveTo use electronic health record (EHR) data to (1) assess the temporal trends in treatment decisions and patient outcomes and (2) emulate a randomized clinical trial (RCT) using EHR data with proper adjustment for temporal trends.Design, setting, and participantsThe Clinical Outcomes of Surgical Therapy (COST) Study Group Trial assessing overall survival of patients with stages I to III early-stage colon cancer was chosen as the target trial. The RCT was emulated using EHR data of patients from a single health care system cohort who underwent colectomy for early-stage colon cancer from January 1, 2006, to December 31, 2017, and were followed up to January 1, 2020, from Mass General Brigham. Analyses were conducted from December 2, 2019, to January 24, 2022.ExposuresLaparoscopy-assisted colectomy (LAC) vs open colectomy (OC).Main outcomes and measuresThe primary outcome was 5-year overall survival. To address confounding in the emulation, pretreatment variables were selected and adjusted. The temporal trends were adjusted by stratification of the calendar year when the colectomies were performed with cotraining across strata.ResultsA total of 943 patients met key RCT eligibility criteria in the EHR emulation cohort, including 518 undergoing LAC (median age, 63 [range, 20-95] years; 268 [52%] women; 121 [23%] with stage I, 165 [32%] with stage II, and 232 [45%] with stage III cancer; 32 [6%] with colon adhesion; 278 [54%] with right-sided colon cancer; 18 [3%] with left-sided colon cancer; and 222 [43%] with sigmoid colon cancer) and 425 undergoing OC (median age, 65 [range, 28-99] years; 223 [52%] women; 61 [14%] with stage I, 153 [36%] with stage II, and 211 [50%] with stage III cancer; 39 [9%] with colon adhesion; 202 [47%] with right-sided colon cancer; 39 [9%] with left-sided colon cancer; and 201 [47%] with sigmoid colon cancer). Tests for temporal trends in treatment assignment (χ2 = 60.3; P < .001) and overall survival (χ2 = 137.2; P < .001) were significant. The adjusted EHR emulation reached the same conclusion as the RCT: LAC is not inferior to OC in overall survival rate with risk difference at 5 years of -0.007 (95% CI, -0.070 to 0.057). The results were consistent for stratified analysis within each temporal period.Conclusions and relevanceThese findings suggest that confounding bias from temporal trends should be considered when conducting clinical evidence studies with long time spans. Stratification of calendar time and cotraining of models is one solution. With proper adjustment, clinical evidence may supplement RCTs in the assessment of treatment outcome over time.

Project description:IntroductionThe objective of this study is to compare the 5 year overall survival of patients with stage I-III colon cancer treated by laparoscopic colectomy versus open colectomy.MethodsUsing Mecklenburg-Western Pomerania Cancer Registry data from 2008 to 2018, we will emulate a phase III, multicenter, open-label, two-parallel-arm hypothetical target trial in adult patients with stage I-III colon cancer who received laparoscopic or open colectomy as an elective treatment. An inverse-probability weighted Royston‒Parmar parametric survival model (RPpsm) will be used to estimate the hazard ratio of laparoscopic versus open surgery after confounding factors are balanced between the two treatment arms. Further to the hazard ratio, we will also compute differences in the absolute risk (at 1, 3, and 5 years) and restricted mean survival time (up to 1, 3, and 5 years). A weighted Kaplan‒Meier curve will be used to compare five-year overall survival in both treatment arms. Various comparator and sensitivity analyses will be performed to check the robustness of the results that will be estimated by the RPpsm main model. Treatment period- and stage-specific results will also be provided.DiscussionThis study aims to causally model the effect of laparoscopic versus open colectomy on 5 year overall survival using a target trial emulation approach. As the cancer registry data do not cover BMI, comorbidity, and previous abdominal surgery for non-malignant indications, the potential for residual confounding arising from these factors is a limitation of this study. This will be approached in a quantitative bias analysis using the E-method. The results will substantiate existing evidence on the comparative effectiveness of laparoscopic versus open colectomy in patients with stage I-III colon cancer and may guide clinical decisions as to whether a laparoscopic approach is as safe as an open approach in terms of improving 5-year overall survival in these patient groups.

Project description:ImportanceNumerous study findings suggest that the use of laparoscopy is associated with lower health care costs for many operations, including colectomy. The extent to which these differences are due to the laparoscopic approach itself or selection bias from healthier patients undergoing the less invasive procedure is unclear.ObjectiveTo evaluate the differences in Medicare expenditures for laparoscopic and open colectomy.Design, setting, and participantsA population-based study was conducted of Medicare beneficiaries undergoing laparoscopic or open colectomy between January 1, 2010, and December 31, 2012. The dates of the analysis were November 13 to December 10, 2016. Using instrumental variable methods to account for selection bias, actual Medicare payments after each procedure were evaluated. To identify the mechanisms of potential cost savings, the frequency and amount of physician, readmission, and postacute care payments were evaluated. Several sensitivity analyses were performed restricting the study population by patient demographic or surgeon specialty.Main outcomes and measuresActual Medicare expenditures up to 1 year after the index operation.ResultsThe study population included 428 799 patients (mean [SD] age, 74 [10] years; 57.0% female). When using standard methods, patients undergoing laparoscopic colectomy (vs open) had lower total Medicare expenditures (mean, -$5547; 95% CI, -$5408 to -$5684; P < .01). When using instrumental variable methods, which account for potentially unmeasured patient characteristics, patients undergoing laparoscopic colectomy (vs open) still had lower Medicare expenditures (mean, -$3676; 95% CI, -$2444 to -$4907; P < .01), although the magnitude of the association was reduced. When examining the root causes of the difference in costs between patients who underwent laparoscopic and open colectomy, the key drivers were a reduction in costs from readmissions (mean, -$1102; 95% CI, -$1373 to -$831) and postacute care (mean, -$1446; 95% CI, -$1988 to -$935; P < .01).Conclusions and relevanceThis population-based study demonstrates the influence of selection bias on cost estimates in comparative effectiveness research. While the use of laparoscopy reduced total episode payments, the source of savings is in the postacute care period, not the index hospitalization.

Project description:Abstract Background A central lymphadenectomy in right-sided colon cancer involves dissection along the superior mesenteric axis, but the extent is debated due to a lack of consensus and the fear of major complications. This randomized controlled trial compared the rate of postoperative morbidity in patients undergoing laparoscopic versus open right-sided colectomy with central lymphadenectomy. Methods This open, prospective, randomized controlled trial compared patients operated on with open and laparoscopic right-sided colectomy (cStages I–III) with a central lymphadenectomy at two Norwegian institutions between October 2016 and December 2021. Dissections were conducted along the superior mesenteric vein in the laparoscopic group, and along the left anterior border of the superior mesenteric artery in the open group, both according to complete mesocolic excision principles. Surgery was standardized and performed by three experienced surgeons for each study group. The primary outcome of interest was to measure postoperative 30-day complications (Clavien–Dindo ≥ grade II). Results Of 273 eligible patients, 135 were randomized and 128 analysed (63 operated on with open and 65 using laparoscopic procedures). Postoperative complications occurred in 42.8 per cent of the patients treated with open and 38.4 per cent of the patients treated using laparoscopic surgery, P = 0.372. The incidence of Clavien–Dindo grade IIIb complications was 7.9 per cent in the open versus 4.6 per cent in the laparoscopic group, P = 0.341. There were no grade IV or V complications, and no re-operations due to anastomotic leakages. There was no significant difference in the mean(s.e.m.) number of removed lymph nodes (open versus laparoscopic respectively: 31.9(1.8) versus 29.3(1.3); P = 0.235). Conclusion There was no significant difference in complications between the two groups. Standardized oncologic right-sided colectomy with central lymphadenectomy along the mesenterial root was performed safely, both open and laparoscopic, with incidence of major complications ranging between 4.6 and 7.9 per cent and no re-operations for anastomotic leakage. Radicality in terms of lymphadenectomy was comparable between the two groups. Registration number: NCT03776591 (http://www.clinicaltrials.gov). Oncologic right-sided colectomy is demanding and central lymphadenectomy varies. We compared open and laparoscopic approaches, and found no difference in bleeding, postoperative complications, or removed lymph nodes.

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Comparative effectiveness of laparoscopy vs open colectomy among nonmetastatic colon cancer patients: an analysis using the National Cancer Data Base.

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Comparative effectiveness of laparoscopy vs open colectomy among nonmetastatic colon cancer patients: an analysis using the National Cancer Data Base.

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