Dataset Information

Institutional variation in survival and morbidity in laparoscopic surgery for colon cancer: From the data of a randomized controlled trial comparing open and laparoscopic surgery (JCOG0404).

ABSTRACT:

Background

Institutional variation in outcomes is a key factor to ascertain the generalizability of results and reliability of the clinical trial. This study evaluated institutional variation in survival and postoperative complications using data from JCOG0404 comparing laparoscopic colectomy (LAP) with open colectomy (OP).

Methods

Institutions with fewer than 10 registered patients were excluded from this analysis. Institutional variation was evaluated in terms of early postoperative complications, overall survival, and relapse-free survival and estimated using a mixed-effect model with institution as a random effect after adjusting for background factors.

Results

This analysis included 1028 patients in the safety analysis and 1040 patients in the efficacy analysis from 26 institutions. In the safety analysis, there was no variation in grades 3-4 early postoperative complications (in OP, median 6.3% [range 6.3%-6.3%]; in LAP, median 2.6% [range 2.6%-2.6%]), but some variation in grades 1-4 early postoperative complications was observed (in OP, median 20.8% [range 13.2%-31.8%]; in LAP, median 11.9% [range 7.2%-28.7%]), and that in grades 2-4 was observed only in LAP (median 8.8% [range 4.7%-24.0%]; in OP, median 12.7% [range 12.7%-12.7%]). Two specific institutions showed especially high incidences of postoperative complications in LAP. In the efficacy analysis, there was no institutional variation in OP, although a certain variation was observed in LAP.

Conclusions

Some institutional variations in safety and efficacy were observed, although only in LAP. We conclude that a qualification system, including training and education, is needed when new surgical techniques such as laparoscopic surgery are introduced in clinical practice.

SUBMITTER: Katayama H

PROVIDER: S-EPMC8560602 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Publications

Institutional variation in survival and morbidity in laparoscopic surgery for colon cancer: From the data of a randomized controlled trial comparing open and laparoscopic surgery (JCOG0404).

Katayama Hiroshi H Inomata Masafumi M Mizusawa Junki J Nakamura Kenichi K Watanabe Masahiko M Akagi Tomonori T Yamamoto Seiichiro S Ito Masaaki M Kinugasa Yusuke Y Okajima Masazumi M Takemasa Ichiro I Okuda Junji J Shida Dai D Kanemitsu Yukihide Y Kitano Seigo S

Annals of gastroenterological surgery 20210712 6

<h4>Background</h4>Institutional variation in outcomes is a key factor to ascertain the generalizability of results and reliability of the clinical trial. This study evaluated institutional variation in survival and postoperative complications using data from JCOG0404 comparing laparoscopic colectomy (LAP) with open colectomy (OP).<h4>Methods</h4>Institutions with fewer than 10 registered patients were excluded from this analysis. Institutional variation was evaluated in terms of early postopera ...[more]

PMID: 34755014

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Project description:Studies evaluating the outcomes after laparoscopic resections of transverse colon cancers are scant. This manuscript aimed to compare surgical and oncological outcomes after laparoscopic (Lap) and open procedures for transverse colon carcinomas. All consecutive patients who underwent resection for a cancer located in the transverse colon between 2003 and 2019 were reviewed. Patients were categorized according to the surgical approach (Lap versus open) and groups were compared. Outcome measures were the short-term results, complications and functional recovery; moreover, recurrence-free survival (RFS) and overall survival (OS) rates were compared overall and after propensity score matching (PSM) based on age, sex, ASA classification, BMI, carcinoembryonic antigen (CEA) level, use of postoperative chemotherapy, location of tumour, stage and grading, operation time, blood loss and complications. Of 248 transverse resections reviewed, 146 (81 Lap and 65 open) were selected for data analysis. Blood loss, fluid intake and the incidence of wound infection were significantly lower and the hospital stay was significantly shorter in the Lap group (P < 0.001). The operation time and incidence of complications (Clavien-Dindo classification grade 3 or above) did not differ significantly between the two groups. Mean follow-up was of 75.4 months in the Lap group and 78.6 months in the open group. Regression analyses showed that OS was associated with the postoperative carcinoembryonic antigen (CEA) level (hazard ratio 1.18 (95 per cent c.i. 1.10 to 1.27); P < 0.001), BMI (hazard ratio 0.81 (95 per cent c.i. 0.68 to 0.96); P = 0.017), operation time (hazard ratio 0.99 (95 per cent c.i. 0.97 to 1.00; P = 0.010), and postoperative chemotherapy (hazard ratio 0.27 (95 per cent c.i. 0.08 to 0.96); P = 0.042), while RFS was associated with the postoperative CEA level (hazard ratio 1.13 (95 per cent c.i. 1.07 to 1.20); P < 0.001). PSM selected 42 patients for data comparison of long-term results, and showed no significant differences between groups (RFS: P = 0.530; OS: P = 0.561). Lap and open resections for transverse colon cancer provided similar outcomes in terms of severe post-operative complication and long-term results.

Project description:BackgroundLaparoscopic surgery for colon cancer is associated with improved recovery and similar cancer outcomes at 3 and 5 years in comparison with open surgery. However, long-term survival rates have rarely been reported. Here, we present survival and recurrence rates of the Dutch patients included in the COlon cancer Laparoscopic or Open Resection (COLOR) trial at 10-year follow-up.MethodsBetween March 1997 and March 2003, patients with non-metastatic colon cancer were recruited by 29 hospitals in eight countries and randomised to either laparoscopic or open surgery. Main inclusion criterion for the COLOR trial was solitary adenocarcinoma of the left or right colon. The primary outcome was disease-free survival at 3 years, and secondary outcomes included overall survival and recurrence. The 10-year follow-up data of all Dutch patients were collected. Analysis was by intention-to-treat. The trial was registered at ClinicalTrials.gov (NCT00387842).ResultsIn total, 1248 patients were randomised, of which 329 were Dutch. Fifty-eight Dutch patients were excluded and 15 were lost to follow-up, leaving 256 patients for 10-year analysis. Median follow-up was 112 months. Disease-free survival rates were 45.2 % in the laparoscopic group and 43.2 % in the open group (difference 2.0 %; 95 % confidence interval (CI) -10.3 to 14.3; p = 0.96). Overall survival rates were 48.4 and 46.7 %, respectively (difference 1.7 %; 95 % CI -10.6 to 14.0; p = 0.83). Stage-specific analysis revealed similar survival rates for both groups. Sixty-two patients were diagnosed with recurrent disease, accounting for 29.4 % in the laparoscopic group and 28.2 % in the open group (difference 1.2 %; 95 % CI -11.1 to 13.5; p = 0.73). Seven patients had port- or wound-site recurrences (laparoscopic n = 3 vs. open n = 4).ConclusionsLaparoscopic surgery for non-metastatic colon cancer is associated with similar rates of disease-free survival, overall survival and recurrences as open surgery at 10-year follow-up.

Project description:Importance:Colon surgery is associated with a high rate of surgical site infection (SSI), and there is an urgent need for strategies to reduce infection rates. Objective:To assess whether laparoscopic colon surgery is associated with a lower surgical site infection rate than open-approach laparoscopy, especially in patients with medically complex conditions. Design, Setting, and Participants:This cohort study used previously validated diagnosis and procedure codes from Medicare beneficiaries who underwent colon surgery from January 1, 2009, to November 30, 2013. Analyses were performed from August 1 to December 31, 2018. Main Outcomes and Measures:Outcome measures were SSI events, medical comorbidities, and laparoscopic or open approach procedures. Results:A total of 229 726 patients (mean [SD] age, 74.3 [9.4] years; 128 499 [55.9%] female) underwent colon procedures. There were 105 144 laparoscopic procedures and 124 582 open procedures. The overall mean SSI rate was 6.2%, varying by surgical procedure from 5.8% to 7.6%. Among the full study population, adjusted model results showed a significant association of laparoscopy with lower odds of SSI (odds ratio, 0.43; 95% CI, 0.41-0.46; P < .001). When stratified by surgical approach, the mean SSI rates were 4.1% (procedure-specific range, 3.9%-5.1%) for the laparoscopic approach and 7.9% (procedure-specific range, 7.4%-10.2%) for the open approach. When stratified by Elixhauser score groups, the mean SSI rates were 6.2% (procedure-specific range, 3.2%-8.7%) for group 1 (0-1 comorbidity), 5.5% (procedure-specific range, 3.6%-11.1%) for group 2 (2 comorbidities), and 6.6% (procedure-specific range, 4.6%-10.6%) for group 3 (3-13 comorbidities). An interaction was also observed between laparoscopic approach and Elixhauser groups, with increased odds of SSI among patients who had 3 to 13 comorbidities present at the time of the procedure (odds ratio, 1.21; 95% CI, 1.11-1.32) compared with patient groups with fewer comorbidities. The population attributable fraction of SSIs for use of the open approach was 34.2%. A total of 2317 of 3882 hospitals (59.7%) performed few (0%-10%) or most (>50%) procedures laparoscopically. Conclusions and Relevance:Policy changes that promote surgical education and resources for laparoscopy, especially at low-adoption hospitals, may be associated with reduced colon SSI rates. Support of the development of innovative educational policies may help achieve improvement in patient outcomes and decreased health care use in colon surgery.

Project description:BackgroundThe THUNDERBEAT is a multi-functional energy device which delivers both ultrasonic and bipolar energy, but there are no randomized trials which can provide more rigorous evaluation of the clinical performance of THUNDERBEAT compared to other energy-based devices in colorectal surgery. The aim of this study was to compare the clinical performance of THUNDERBEAT energy device to Maryland LigaSure in patients undergoing left laparoscopic colectomy.MethodsProspective randomized trial with two groups: Group 1 THUNDERBEAT and Group 2 LigaSure in a single university hospital. 60 Subjects, male and female, of age 18 years and above undergoing left colectomy for cancer or diverticulitis were included. The primary outcome was dissection time to specimen removal (DTSR) measured in minutes from the start of colon mobilization to specimen removal from the abdominal cavity. Versatility (composite of five variables) was measured by a score system from 1 to 5 (1 being worst and 5 the best), and adjusted/weighted by coefficient of importance with distribution of the importance as follow: hemostasis 0.275, sealing 0.275, cutting 0.2, dissection 0.15, and tissue manipulation 0.1. Other variables were: dryness of surgical field, intraoperative and postoperative complications, and mortality. Follow-up time was 30 days.Results60 Patients completed surgery, 31 in Group 1 and 29 in Group 2. There was no difference in the DTSR between the groups, 91 min vs. 77 min (p = 0.214). THUNDERBEAT showed significantly higher score in dissecting and tissue manipulation in segment 3 (omental dissection), and in overall versatility score (p = 0.007) as well as versatility score in Segment 2 (retroperitoneal dissection p = 0.040) and Segment 3 (p = 0.040). No other differences were noted between the groups.ConclusionsBoth energy devices can be employed effectively and safely in dividing soft tissue and sealing mesenteric blood vessels during laparoscopic left colon surgery, with THUNDERBEAT demonstrating some advantages over LigaSure during omental dissection and tissue manipulation.Clinicaltrialgov # NCT02628093.

Dataset Information

Institutional variation in survival and morbidity in laparoscopic surgery for colon cancer: From the data of a randomized controlled trial comparing open and laparoscopic surgery (JCOG0404).

Background

Methods

Results

Conclusions

Publications

Institutional variation in survival and morbidity in laparoscopic surgery for colon cancer: From the data of a randomized controlled trial comparing open and laparoscopic surgery (JCOG0404).

Similar Datasets

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