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Objective:To analyze the quality of surgical specimens of rectal cancer in the Chinese transanal total mesorectal excision (taTME) registry collaborative (CTRC) database.Methods:The retrospective and descriptive study was conducted. Based on the concept of real-world research, the clinicopathological data of 1 761 patients with rectal cancer in the CTRC database who underwent taTME in 40 medical centers, including the Beijing Friendship Hospital of Capital Medical University et al, from November 15, 2017 to December 31, 2022 were collected. There were 1 212 males and 549 females, aged 62(range, 53-68)years. Observation indicators: (1) preoperative examinations; (2) neoadjuvant therapy; (3) postoperative examinations. Measurement data with skewed distri-bution were represented as M(range). Count data were described as absolute numbers. Results:(1) Preoperative examinations. Of the 1 761 patients, 1 324 patients underwent preoperative pelvic magnetic resonance imaging examination, and the results showed that 4 cases as clinical T0 stage, 30 cases as clinical T1 stage, 250 cases as clinical T2 stage, 828 cases as clinical T3 stage, 141 cases as clinical T4 stage, 11 cases as clinical Tx stage, 60 cases missing clinical T staging data, 490 cases as clinical N0 stage, 373 cases as clinical N1 stage, 311 cases as clinical N2 stage, 86 cases as clinical Nx stage, 64 cases missing clinical N staging data, 156 cases with mesorectal fascia invasion, 223 cases with extraintestinal blood vessels invasion. The distance from lower margin of tumor to anal margin of 1 324 patients was 50(range, 40-60)mm. (2) Neoadjuvant therapy. Of the 1 761 patients, 873 patients underwent neoadjuvant therapy, including 17 cases receiving radiotherapy alone, 155 cases receiving chemotherapy alone, 43 cases receiving short-course simultaneous chemoradiotherapy, 26 cases receiving short-course simultaneous chemoradiotherapy and delayed surgery, 1 case receiving contact radiotherapy, 277 cases receiving long-course simultaneous chemoradiotherapy, 9 cases receiving other treatments, and 345 cases missing neoadjuvant therapy data. (3) Postoperative examinations. Of the 1 761 patients, 1 584 cases achieved R 0 resection, 23 cases achieved R 1 resection, 1 case achieved R 2 resection, and there were 153 cases missing surgical margin data. The tumor diameter, number of lymph nodes harvest and positive rate of intravascular tumor thrombus were 30(range, 20-45)cm, 13(range, 10-17) and 20.794%(330/1 587) in 1 761 patients. There were 1 647 patients with circumferential margin records, which showed positive in 51 cases, and the minimum distance from deep part of tumor to circumferential margin was 5(rang, 3-13)mm in 1 647 patients. There were 547 cases with distal margin records, which showed positive in 4 cases, and the distance from lower margin of tumor to distal margin was 20(10-25)mm in 547 cases. There were 1 698 patients with specimen integrity records, which showed intact specimen in 1 436 cases, fair specimen in 233 cases, poor specimen in 8 cases, unevaluated specimen in 21 cases, and there were 20 cases with rectal tube perforation. Of the 1 761 patients, cases as pathological T0 stage, Tis stage, T1 stage, T2 stage, T3 stage, T4 stage was 103, 23, 145, 515, 712, 179, respectively, and there were 4 cases of pathology that could not be evaluated and 80 cases missing pathological T staging data. Of the 1 761 patients, cases as pathological N0 stage, N1a stage, N1b stage, N1c stage, N2a stage, N2b stage was 1 117, 189, 133, 66, 109, 68, respectively, and there were 79 cases missing pathological N staging data. Of the 1 761 patients, there were 79 cases with distant metastasis, 1 591 cases without distant metastasis, and 91 cases without data of tumor metastasis. Of the 873 patients undergoing neoadjuvant therapy, there were 405 patients with tumor regression grade records including 105 cases as grade 1, 142 cases as grade 2, 91 cases as grade 3, 43 cases as grade 4, 24 cases as grade 5. Conclusions:In China, the quality of surgical specimens of taTME for rectal cancer is good with low positive rate of resection margin. It is recommended that using a formatted postoperative pathological report for good quality control of pathological report of surgical specimen.
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High-quality clinical research is an important method to improve clinical diagnosis and treatment, promote discipline construction, and expand the frontier of medicine. In recent years, multi-center clinical studies in colorectal surgery in China have increased, and the level of clinical research has gradually improved, accumulating a wealth of clinical research experience. Innovative research topics and scientific design are the foundations of high-quality clinical research. Standardization of surgical techniques and quality control at all steps of the study are key to high-quality research. At the same time, researchers should establish a data management system, select appropriate data collection systems, and conduct regular data checks and feedback to ensure the quality of research data. Fully utilizing the advantages of case resources and further enhancing clinical research capabilities will provide assistance in promoting high-quality clinical research in the field of colorectal surgery in China. The authors summarize the experience of high-quality clinical research in colorectal surgery at home and abroad, in order to further promote the development of high-quality clinical research in China.
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Venous thromboembolism (VTE) is a common perioperative complication in patients with malignant tumors. Factors such as colorectal cancer itself and surgical treatment can increase the risk of perioperative VTE. In recent years, with the development of the concept of enhanced recovery after surgery, the understanding of cancer-associated venous thrombosis has deepened, and significant progress has been made in the risk assessment, prevention and treatment strategies of cancer-associated VTE. This article will review the pathogenesis, risk factors, risk assessment, prevention and treatment strategies of colorectal cancer-associated VTE, in order to provide evidence-based medical basis and research ideas for the standardized management and future research of colorectal cancer-associated VTE.
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The number of colorectal cancer patients in China ranks the top in the world, but there are few international guidelines for the diagnosis and treatment of colorectal cancer formulated by Chinese, nor high-level evidence-based medicine research of colorectal cancer from China. Transanal total mesorectal excision (taTME) is a new technology in the field of colorectal surgery in recent years. At present, clinical practice related to taTME has been carried out simul-taneously with clinical researches in the world. Based on the experience of participating in the top clinical trials in the field of international colorectal surgery, like the COLOR series prospective research, the authors introduce the organization and implementation of COLOR Ⅲ research in China. It is hoped that the COLOR series trials will become an example in the field of high-quality surgical clinical research, so as to improve the clinical research level of colorectal surgery in China.
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The idea, development, exploration, assessment, and long-term follow-up (IDEAL) framework and recommendations provide a guiding path for high-quality research and practice for surgical technology innovation. Transanal total mesorectal excision, as a new technology in the field of colorectal surgery, has evolved step by step following the IDEAL framework. At the technical design and development stage, the technique feasibility is verified. At the exploratory stage, small-scale clinical practice is conducted, standardized diagnosis and treatment and surgical technique are developed, and structured training is carried out. During the assessment stage, large-scale rando-mized controlled studies are conducted to confirm the safety and efficacy. Subsequently, long-term monitoring and follow-up of the technique is carried out in clinical practice. All the processes become good example in the field of surgical clinical research. The authors summarize the pioneering works of the research team in quality control, in order to provide references for peers.
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Objective:To investigate the incidence and influencing factors of parastomal hernia in patients with permanent colostomy.Methods:The retrospective cohort study was conduc-ted. The clinicopathological data of 72 patients with permanent colostomy in the Beijing Friendship Hospital of Capital Medical University from January 2016 to June 2020 were collected. There were 50 males and 22 females, aged (66±12)years. Observations indicators: (1) follow-up; (2) analysis of factors affecting the incidence of parastomal hernia; (3) comparison of the incidence of parastomal hernia in patients with different age. Follow-up was conducted using outpatient examination. Patients were followed up once every 12 months after surgery to detect the incidence of parastomal hernia up to September 2021. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the t test. Measurement data with skewed distribution were represented as M(range). Count data were expressed as absolute numbers and percentages, and comparison between groups was conducted using the chi-square test. Univariate analysis was conducted using the corresponding statistical methods based on data type. Multivariate analysis was conducted using the Logistic regression model. Kaplan-Meier method was used to draw the parastomal hernia occurrence curve and calculate the incidence rate of parastomal hernia and Log-rank test was used to analyze the incidence of parastomal hernia. Results:(1) Follow-up. All 72 patients were followed up for 23(range, 12?76)months. During the follow-up, there were 31 patients developed parastomal hernia, with the incidence as 20.8%(15/72), 36.1%(26/72) and 43.1%(31/72) at postoperative 1 year, postoperative 2 year and postoperative 5 year, respectively. Of the 31 patients with parastomal hernia, there were 21 cases of type Ⅰ, 3 cases of type Ⅱ and 7 cases of type Ⅲ. Patients with parastomal hernia recovered with conservative treatment. (2) Analysis of factors affecting the incidence of parastomal hernia. Results of univariate analysis showed that age, subcutaneous fat thickness and rectus abdominis thickness were related factors affecting the incidence of parastomal hernia ( χ2=7.98, t=?2.95, 2.02, P<0.05). Results of multivariate analysis showed that age, subcutaneous fat thickness and rectus abdominis thickness were independent factors affecting the incidence of parastomal hernia ( odds ratio=4.07, 3.19, 0.07, 95% confidence interval as 1.46?11.32, 1.43?7.09, 0.01?0.84, P<0.05). (3) Comparison of the incidence of parastomal hernia in patients with different age. Of the 72 patients, there were 37 cases with age <65 years and 35 cases with age >65 years. Of the 31 patients with parastomal hernia, there were 10 cases with age<65 years and all of them with type Ⅰ parastomal hernia, and the incidence of parastomal hernia in postoperative 1 year and postoperative 2 year was 13.5%(5/37) and 27.0%(10/37), respectively. There were 21 cases with age ≥65 years and cases with type Ⅰ, type Ⅱ and type Ⅲ parastomal hernia were 11, 3 and 7, respectively. The postoperative 1 year and postoperative 2 year incidence of parastomal hernia in the 21 cases was 28.6%(10/35) and 45.7%(16/35), respectively. There was a significant difference in the incidence of parastomal hernia between patients<65 years and ≥65 years ( χ2=9.28, P<0.05). Conclusion:Age, subcutaneous fat thickness and rectus abdominis thickness are independent factors affecting the incidence of parastomal hernia.
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Objective:To investigate the clinical value of magnetic resonance imaging (MRI) in predicting pathological complete response (pCR) after immunotherapy combined with neo-adjuvant therapy for local advanced rectal cancer.Methods:The retrospective and descriptive study was conducted. The clinicopathological data of 48 patients with local advanced rectal cancer who were admitted to Beijing Friendship Hospital of Capital Medical University from January 2020 to March 2022 were collected. There were 35 males and 13 females, aged 62(32?77)years. Of 48 patients, 30 patients received neoadjuvant therapy, 18 patients received immunotherapy combined with neoadjuvant therapy. All patients underwent total mesorectal excision. Observation indicators: (1) T staging on MRI and postoperative pathological examination after neoadjuvant therapy and immunotherapy combined with neoadjuvant therapy; (2) changes of apparent diffusion coefficients (ADC) in pCR and non-pCR patients after neoadjuvant therapy and immunotherapy combined with neoadjuvant therapy; (3) evaluation of predictive performance of MRI for pCR after immunotherapy combined with neoadjuvant therapy. Measurement data with normal distribution were represented as Mean± SD, and t test was used for comparison between groups. Measurement data with skewed distribution were represented as M(range). Count data were expressed as absolute numbers or percentages. Sensitivity, specificity and accuracy were used to evaluate the predictive performance. Results:(1) T staging on MRI and postoperative pathological examination after neoadjuvant therapy and immunotherapy combined with neoadjuvant therapy. Of the 30 patients receiving neoadjuvant therapy, 1 patient in stage T2 showed stage T2 on both MRI and postoperative pathological examination after neoadjuvant therapy, 16 patients in stage T3 showed stage T0, T1, T2, T3, T4 of 0, 1, 6, 9, 0 cases and 3, 0, 8, 4, 1 cases on MRI and postoperative pathological examination respectively after neoadjuvant therapy, 13 patients in stage T4 showed stage T0, T1, T2, T3, T4 of 0, 0, 1, 2, 10 cases and 1, 0, 4, 7, 1 cases on MRI and postoperative pathological examination respectively after neoadjuvant therapy. The pCR rate was 13.3%(4/30) and the accuracy rate of MRI was 43.33% for patients with neoadjuvant therapy. Of the 18 patients receiving immunotherapy combined with neoadjuvant therapy, 12 patients in stage T3 showed stage T0, T1, T2, T3, T4 in 4, 2, 2, 4,0 cases and 5, 1, 1, 5, 0 cases on MRI and postoperative pathological examination respectively after immunotherapy combined with neoadjuvant therapy, 6 patients in stage T4 showed stage T0, T1, T2, T3, T4 in 0, 0, 1, 3, 2 cases and 4, 0, 0, 2, 0 cases on MRI and postoperative pathological examination respectively after immunotherapy combined with neoadjuvant therapy. The pCR rate was 50.0%(9/18) and the accuracy rate of MRI was 38.89% for patients with neoadjuvant therapy. (2) Changes of ADC in pCR and non-pCR patients after neoadjuvant therapy and immunotherapy combined with neoadjuvant chemoradiotherapy. Of the 30 patients receiving neoadjuvant therapy, the ADC differences were 0.30±0.04 and 0.21±0.17 for 4 pCR and 26 non-pCR patients, respectively, showing a significant difference ( t=2.36, P<0.05). Of the 18 patients receiving immunotherapy combined with neoadjuvant therapy, the ADC change rates and ADC differences were 40%±14% and 0.39±0.14 for 9 pCR patients, versus 22%±13% and 0.21±0.12 of 9 non-pCR patients, showing significant differences in the above indicators ( t=2.86, 2.79, P<0.05). Receiver operation charac-teristic curve analysis of ADC change rate and ADC difference associated with pCR for 18 patients receiving immunotherapy combined with neoadjuvant therapy suggested that the areas under the curve were 0.81 (95% confidence interval as 0.60?1.00, P<0.05) and 0.86 (95% confidence interval as 0.70?1.00, P<0.05), with cutoff values as 0.23 and 0.36, respectively. (3) Evaluation of predictive performance of MRI for pCR after immunotherapy combined with neoadjuvant therapy. For the 18 patients receiving immunotherapy combined with neoadjuvant therapy, the sensitivity, specificity, accuracy were 33.33%, 88.89%, 61.11% of stage T0 on MRI for predicting pCR, 88.89%, 55.56%, 72.22% of down-staging of T staging on MRI for predicting pCR, and all 77.78% of ADC difference greater than the cutoff value for predicting pCR. Conclusions:Patients with local advanced rectal cancer who received immunotherapy combined with neoadjuvant therapy achieve a higher pCR rate. ADC difference and down-staging of T staging on MRI can predict pCR effectively.
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Objective:To explore whether there are gender differences in clinical and pathological characteristics and prognosis of young patients with rectal cancer (under 50 years old), and to analyze the risk factors affecting the prognosis of young patients with rectal cancer.Methods:The medical records of 85 young rectal cancer patients admitted to Beijing Friendship Hospital Affiliated to Capital Medical University from January 2015 to December 2020 were retrospectively collected. According to gender, they were divided into male group ( n=50) and female group ( n=35). The age was (43.67±5.50) years old, ranging from 26 to 50 years old. Primary outcome measures were sex, disease-free survival, and overall survival. Secondary outcomes were family history, body mass index (BMI), clinical stage, anemia, whether the female patient was menopausal, whether the female patient took oral estrogen, the location of the primary lesion, whether neoadjuvant therapy was performed, pathological stage, whether accompanied with vascular nerve invasion, and whether postoperative adjuvant therapy was performed. R4.0.2 software was used for statistical analysis. The measurement data with normal distribution in the collected data were expressed as mean±standard deviation ( ± s), and the comparison between groups was analyzed by t test. Count data were expressed as constituent ratio, and analyzed using the chi-square test or Fisher′s exact test. The survival curve was drawn by Kaplan-Meier method, and the difference in survival rate was tested by Log-rank test. Factors with statistical significance in univariate analysis were included in COX proportional regression model for multivariate analysis to screen independent risk factors affecting overall survival. Results:Compared with male patients, a higher proportion of young female patients with rectal cancer were diagnosed with anemia before surgery (42.9% vs 22.0%, P=0.040). The 1-year, 3-year and 5-year overall survival rates were 94.3%, 80.0% and 68.6% in young female patients, and 98.0%, 90.0% and 90.0% in young male patients, respectively. The median disease-free surival was 31.6 months for women and 34.4 months for men. Multivariate analysis showed that female( HR=3.799, 95% CI: 1.312-11.002, P=0.014)and BMI( HR=0.846, 95% CI: 0.724-0.989, P=0.036)were independent risk factors affecting the prognosis of young patients with rectal cancer. Conclusions:Young female patients have a worse prognosis than male patients. Female and BMI are independent risk factors for the prognosis of young rectal cancer patients, and gender should be the key research object of observation in young rectal cancer patients.
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Objective:To explore the prognostic value of circulating tumor cell (CTC) for colorectal cancer.Method:We analyze the correlation between CTC and clinicopathological data, survival curve and overall survival.Results:The positive rates of preoperative and postoperative CTC in 181 colorectal cancer patients were 66.3% and 65.7% respectively ( χ2=0.012, P=0.912). The postoperative CTC positive rates for recurrence and non-recurrence of stage Ⅱ colorectal cancer were 29.2% and 8.0%, respectively ( χ2=4.303, P=0.038). The progress free survuval of CTC-positive and CTC-negative in postoperative stage Ⅱ colorectal cancer patients were 28.7 months and 34.0 months, respectively ( χ2=4.096, P=0.043). Conclusion:Postoperative CTC detection has predictive prognostic value for patients with stage Ⅱ colorectal cancer.
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The medical data processed and analyzed in clinical research often contain a large number of personal information. Therefore, researchers should pay attention to the safety management of medical data during clinical research. The Data Security Law of People's Republic of China and the Personal Information Protection Law of People's Republic of China implemented on 1 st September and 1 st November 2021 respectively establish legal basis for data security and personal information protection and point out the direction for medical data security, which indicate that data governance has entered the 'strong regulatory era'. In the process of medical data collection and application of clinical research, respecting and protecting the privacy and safety of patients, ensuring the quality of medical data, safely managing medical data and carrying out high-quality clinical research will be an important test for the collection and application of clinical scientific research data under the new legal background.
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Objective:To investigate the effect of obstruction on the prognosis and possible mechanisms in colorectal cancer patients.Methods:Among 1574 cases of colorectal cancer who were treated in Beijing Friendship Hospital, Capital Medical University from January 2003 to December. 2014, 194 cases had preoperative intestinal obstruction. Firstly, described the clinical characteristics of 194 patients with obstruction, then COX multivariate regression analysis was performed on the 1574 colorectal cancer cohort to confirm whether the preoperative obstruction was independent predictor for the overall survival. Finally, propensity score matching method was used to match obstruction and non-obstruction cases, then compared overall survival difference.Results:In 194 cases of obstructive colorectal cancer, 60.3% and 37.1% of the tumors were located in the left and right respectively. The 55.7% of the patients had tumors larger than 5 cm in diameter, the median survival time was 39.7 months (95% CI: 28.3-60.4). Multivariate COX analysis, after adjusted for related confounding factors, found that preoperative obstruction is still an independent risk factor for poor prognosis ( HR=1.41, 95% CI: 1.01-1.97). After propensity score matching, 140 and 560 patients were included in the obstructive group and the non-obstructive group. The two groups were more balanced in most baseline characteristics. The median survival time of the two groups was 42.4 and 116.3 months ( P<0.001), the overall survival of obstructive patients was significantly worse than that of non-obstructive patients. Conclusions:Preoperative obstruction is an independent risk factor for poor prognosis of colorectal cancer. This may be due to the difficulty of surgery and low radical cure rate for obstructive colorectal cancer.
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Objective:To investigate the relationship between systematic immune-inflamma-tion index(SII) and clinicopathological characteristics for colorectal cancer.Methods:The retrospec-tive cohort study was conducted. The clinicopathological data of 513 patients with colorectal cancer who were admitted to the Beijing Friendship Hospital of Capital Medical University from February 2019 to May 2021 were collected. There were 311 males and 202 females, aged (64±12)years. Observation indicators: (1) SII of colorectal cancer and relationship between SII and clinicopatholo-gical characteristics; (2) influencing factors for SII in colorectal cancer patients. According to the median of SII as the cutoff value, the patients were divided into high SII and low SII patients. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was analyzed using the t test. Count data were represented as absolute numbers or percen-tages, and comparison between groups was conducted using the chi-square test. Measurement data with skewed distribution were represented as M( P25, P75), and comparison between groups was analyzed using the non-parameter rank sum test. Comparison of ordinal data was analyzed using the Mann-Whitney U non-parameter test. Variables with statistically significant differences between groups were included for further analysis. Pearson correlation coefficient analysis was used for continuous data, and Wilcoxon or Kruskal-Willas analysis was used for categorical data and Bonferroni correction was performed. Univariate and multivariate linear regression analyses were conducted. Results:(1) SII of colorectal cancer and relationship between SII and clinicopathological charac-teristics: the SII of 513 patients was 355(253,507). Taking the median SII 355 as the cutoff value, 257 of 513 patients with SII>355 had high SII and 256 cases with SII≤355 had low SII. Of high SII patients, the Karnofsky performance status(KPS) score, preoperative albumin(Alb), CA125, cases with tumor located at left or right hemicolon, tumor diameter, cases with laparoscopic assisted surgery or laparotomy (surgical approach), cases in stage T0, T1, T2, T3, T4 (pathological T staging), cases in stage Ⅰ, Ⅱ, Ⅲ, Ⅳ (pathological TNM staging) were 87±17, (37±5)g/L, 8.80 U/mL(5.90 U/mL, 14.15 U/mL), 174, 83, (5.2±2.8)cm, 208, 44, 5, 19, 25, 131, 63, 34, 98, 94, 14. The above indicators of low SII patients were 91±13, (38±4)g/L, 7.20 U/mL(5.40 U/mL, 10.03 U/mL), 200, 56, (4.0±1.9)cm, 221, 24, 8, 39, 35, 118, 45, 61, 84, 79, 12. There were significant differences in above indicators between the two groups ( t=-2.770, -3.211, Z=-3.799, χ2=7.050, t=5.324, χ2=6.179, Z=-3.390, -2.227, P<0.05). Results of Pearson correlation coefficient analysis showed that SII was positively correlated with the tumor diameter ( r=0.390, P<0.05), and negatively correlated with preoperative Alb ( r=-0.200, P<0.05). Results of Wilcoxon analysis showed that SII was 447(311,720), 352(251,493) in patients with tumor located at right hemicolon and left hemicolon, 439(284,640), 345(243,481) in patients undergoing laparotomy and laparoscopic assisted surgery, respectively. There were signi-ficant differences in SII between patients with tumor located at right and left hemicolon,between patients undergoing laparotomy and laparoscopic assisted surgery ( P<0.05). Results of Kruskal-Willas analy-sis showed that SII was 289(201,463), 296(210,398), 329(252,446), 369(265,505), 434(274,631) in patients with pathological T staging as stage T0, stage T1, stage T2, stage T3, stage T4, respectively, and 307(226,400), 380(260,503), 381(272,563), 376(273,634) in patients with patho-logical TNM staging as stage Ⅰ, stage Ⅱ, stage Ⅲ, stage Ⅳ, respectively. There were significant differences in SII between patients with different pathological T staging and between patients with different pathological TNM staging ( P<0.05). (2) Influencing factors for SII in colorectal cancer patients: results of univariate analysis showed that KPS score, preoperative Alb, CA125, tumor location, tumor diameter, patholo-gical N staging, pathological TNM staging were related factors for SII in colorectal cancer patients ( Beta=-3.5, -15.8, 3.7, 106.3, 51.8, 115.1, 104.7, 141.2,95% confidence interval as -5.7 to -1.3, -22.6 to -9.1, 1.8 to 5.5,34.6 to 177.9, 38.5 to 65.2, 40.5 to 189.7, 11.2 to 198.2, 46.9 to 235.9, P<0.05). Multivariate analysis showed that tumor location and tumor diameter were independent influencing factors for SII in colorectal cancer patients ( Beta=79.5, 42.5, 95% confidence interval as 8.4 to 150.7, 26.6 to 58.4, P<0.05). Conclusions:The SII is correlated with tumor location, tumor diameter, preoperative Alb, pathological T staging, pathological TNM staging. Preoperative hypoproteinemia indicates a high SII score. The longer of tumor diameter, right hemicolon tumor and high TNM staging indicate the more serious immune-inflammatory imbalance. Tumor location and tumor diameter are independent influencing factors for SII in colorectal cancer patients.
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Objective:To analyze the prognostic factors of Krukenberg tumors derived from the gastric cancer and colorectal cancer, so as to guide comprehensive treatment; looking for objective and sensitive indicators of ovarian metastasis during the follow-up after the surgery for gastric and colorectal cancer, which provides a basis for early diagnosis.Methods:Retrospectively analyzed the clinical data of 75 patients diagnosed with Krukenberg tumor admitted to Beijing Friendship Hospital, Capital Medical University from June 2007 to February 2020. Log-rank method and COX regression analysis were used to find independent prognostic factors. Wilcoxon rank sum test was used to compare the dynamic changes of ovarian imaging and tumor markers and to find the more sensitive indicators in the follow-up of patients with metachronous metastasis.Results:In the 75 cases, the univariate analysis suggested that CA19-9≥123.5 U/mL ( P=0.001), CA12-5≥37.9 U/mL ( P=0.018), Krukenberg tumor of stomach origin ( P=0.037), extra-ovary metastasis ( P=0.014), and without cytoreductive surgery (CRS) ( P<0.001)were poor prognostic factors. Among them, cytoreductive surgery could significantly improve the prognosis, even if with visible residual lesions, the overall survival was still significantly longer than those who have not undergone cytoreductive surgery ( P=0.004). Multivariate analysis results showed that CA19-9 and cytoreductive surgery ( P=0.001) were independent prognostic factors for patients with Krukenberg tumor; during the postoperative follow-up, ultrasound and CT imaging changes were more sensitive to ovarian metastasis ( P=0.006). Conclusions:CRS can prolong significantly the overall survival (OS) of patients with krukenberg tumor. Patients with simultaneous metastases should not give up the opportunity for surgery, and patients with metachronous metastases should also receive ovary resection procedure, even if with visible residual lesions, the patients can still benefit from the procedure. In the follow-up for gastric and colorectal cancer, attention should be paid to the ovarian ultrasound and CT imaging changes to facilitate early detection of ovarian metastases.
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Objective:To analyze the negative effect of prolonged postoperative ileus on postoperative recovery in patients underwent open alimentary tract surgery.Methods:This study was a retrospective cohort study. The subjects of the study were patients who underwent open gastrointestinal surgery at the General Surgery Department of Beijing Friendship Hospital, Capital Medical University from October 2016 to November 2018. According to the PPOI diagnostic criteria proposed by the University of Auckland, the included patients were classified as PPOI Group ( n=14) and non-PPOI group ( n=112). The postoperative complications, postoperative hospital stay and medical expenses during hospitalization were selected as the study endpoint indicators. T-test or Fisher′s exact test were performed to compare the differences between the two groups, and linear regression analysis was used to explore the independent effects of PPOI on hospital stay and medical expenses. Results:The incidence of PPOI in this study cohort was 11.1%. The total postoperative complications occurred more frequent in PPOI group (64.29% vs 38.39%, P=0.08). The average postoperative hospital stay of patients in the PPOI group was longer than that in non-PPOI group [(21.21±14.83) d vs (13.98±14.21) d, P=0.070]. Adjusting for various possible confounding factors, the PPOI regression coefficient beta (95% CI) that affects the length of hospital stay was [-0.43 (-7.16, 6.3), P=0.90]. The average medical cost of patients in the PPOI group was more than that in non-PPOI group [(104 389.64±52 427.66)元比(79 111.41±50 832.29)元, P=0.070]. Adjusting for various possible confounding factors, the PPOI regression coefficient beta (95% CI) that affects medical expenditure was [-134.12 (-21656.85, 21388.62), P=0.99]. Conclusions:Prolonged postoperative ileus leads to delayed postoperative recovery, which is related to increased postoperative complications, hospital stay duration and medical cost. But it needs further confirmation from large sample data.
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Objective:To investigate the short term efficacy of laparoscopic assisted transanal total mesorectal excision (taTME) for low rectal cancer.Methods:The prospective study was conducted. The clinicopathological data of 80 patients who underwent laparoscopic assisted taTME for low rectal cancer in 8 medical centers，including 27 cases in the First Affiliated Hospital of Jilin University，16 cases in the Daping Hospital of Army Medical University，15 cases in the Beijing Friendship Hospital of Capital Medical University，10 cases in the Peking University Cancer Hospital，7 cases in the Peking Union Medical College Hospital of Chinese Academy of Medical Sciences，2 cases in the Peking University People′s Hospital，2 cases in the Liaoning Cancer Hospital Institute，1 case in the Ruijin Hospital of Shanghai Jiaotong University School of Medicine，from August 2017 to September 2018 were collected. Observation indicators：(1) clinical data of enrolled patients；(2) surgical situations；(3) postoperative histopathological examination；(4)postoperative complications and hospitalization. Measurement data with skewed distribution were represented as M(range). Count data were described as absolute numbers and (or) percentages. Results:(1) Clinical data of enrolled patients：a total of 80 patients were selected for eligibility. There were 59 males and 21 females，aged from 53 to 79 years，with a median age of 61 years. (2）Surgical situations：all 80 patients underwent surgery successfully，including 73 cases undergoing low anterior resection，4 cases undergoing Hartmann operation，1 case undergoing intersphincteric and abdominoperineal resection，1 case undergoing other operations and 1 case missing operation information. Nineteen of the 80 patients underwent transabdominal and transanal operations simultaneously. The operation time of 80 patients was 255 minutes (range，211?305 minutes). Of 80 patients，77 cases had the volume of intraoperative blood loss ≤500 mL，3 cases had the volume of intraoperative blood loss >500 mL，44 cases underwent instrumental anastomosis，24 cases underwent manual anastomosis，12 cases were missing anastomosis information，66 cases had specimens been taken out through anus，2 cases had specimens been taken out through Pfannens-tiel incision，10 cases had specimens been taken out through other ways，2 cases were missing the information of specimens removal ways，57 cases underwent preventive stoma，32 cases under-went anal canal indwelling，30 cases underwent free of splenic flexure and 2 cases were converted to open surgery. (3) Postoperative histopathological examination：of 80 patients，68 cases had the integrity of mesorectal specimens with complete，5 cases had the integrity of mesorectal specimens with near complete，1 case had the integrity of mesorectal specimens with not complete，6 cases were missing the information of integrity of mesorectal specimens，1 case had rectal perforation，1 case had positive circumferential margin and 1 case had positive distal margin. The number of lymph node dissected and diameter of tumor were 12(range，9?16) and 3.0 cm(range，1.9?4.0 cm) of 80 patients. Four of 80 patients achieved pathological complete remission. Cases with tumor stage as T0 stage，Tis stage，T1 stage，T2 stage，T3 stage or T4 stage of the pT staging，cases with tumor stage as N0 stage，N1 stage or N2 stage of the pN staging，cases with tumor stage as M0 stage or M1 stage of the pM staging were 4，2，11，24，35，4，55，21，4，75，5 of 80 patients. (4) Postopera-tive complications and hospitalization：8 of 80 patients underwent anastomotic leakage，including 2 cases with grade A anastomotic leakage，4 cases with grade B anastomotic leakage and 2 cases with grade C anastomotic leakage.Seven of 80 patients underwent intestinal obstruction. The 2 cases with grade A anastomotic leakage were improved after symptomatic drug treatment，the 4 cases with grade B anastomotic leakage were improved after treatment with antibiotics or catheter drainage and the 2 cases with grade C anastomotic leakage were improved after operation. The duration of hospital stay of 80 patients was 14 days(range，11?21 days). No patient died during hospitalization.Conclusion:Laparoscopic assisted taTME for low rectal cancer is safe and feasible，which has a good short term efficacy.
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Objective:To investigate the learning curve of laparoscopic transanal total mesorectal excision (taTME) for rectal cancer operated by one or two surgery teams.Methods:The retrospective cross-sectional study was conducted. Based on the concept of real-world research, the clinical data of 1 458 patients undergoing laparoscopic rectal cancer taTME from 44 medical centers who were registered in the Chinese taTME registry collaborative (CTRC) database from May 2010 to May 2020 were collected. The 1 458 patients were divided into cohorts with one surgery team or two surgery teams according to the operation method. Patients with one surgery team underwent taTME by transabdominal operation and then by transanal operation. Patients with two surgery teams underwent taTME by transabdominal and transanal operation simultaneously with duration of the simutaneous operation time ≥30 minutes. The entire surgical process of patients with two surgery teams is not required to be performed by two surgery teams simutaneously. The clinical data were collected from the medical centers with similar operation amount according to the operation time sequence to analyze the difference between different operation stages and explore the learning curve. The operation time was taken as the parameter to carry out cumulative sum analysis and draw the learning curve of laparoscopic rectal cancer taTME in each medical center. The clinicopathological characteristics of patients from two medical centers with the largest difference in learning curves were analyzed. Observation indicators: (1) screening results of clinical data; (2) clinical data collection of patients with one surgery team; (3) surgical situations of laparoscopic rectal cancer taTME from the one surgery team in different operation stages; (4) learning curve of the one surgery team; (5) clinical data collection of patients with two surgery teams; (6) surgical situations of laparoscopic rectal cancer taTME from the two surgery teams; (7) learning curve of the two surgery teams. The cumulative sum was calculated by the CUSUM=∑i=1nXi-U, where Xi represented the operation time of each taTME, U represented the average operation time of all cases, and n represented the operation number. Fitting process was conducted on scatter plot of learning curves. Taking the apex of learning curve as the boundary, the learning curve was divided into two stages. The abscissa corresponding to the apex of learning curve was the number of operations that needed to be performed to cross the learning curve. Measurement data with normal distribution were represented as Mean±SD. Comparison between two groups was conducted using the t test and comparison between multiple groups was conducted using the ANOVA. Measurement data with skewed distribution were represented as M( P25,P75), and comparison between groups was conducted using the Mann-Whitney U test. Comparison of ordinal data was analyzed using the rank sum test. Count data were analyzed using the chi-square test or Fisher exact probability. Results:(1) Screening results of clinical data:the clinical data of 661 patients from 7 medical centers with one surgery team and two surgery teams were collected. (2) Clinical data collection of patients with one surgery team: the clinical data of 312 patients undergoing laparoscopic rectal cancer taTME from 5 medical centers were collected including 42 cases in the number 2 medical center, 97 cases in the number 20 medical center, 82 cases in the number 33 medical center, 35 cases in the number 37 medical center and 56 cases in the number 39 medical center, respectively. (3) Surgical situations of laparoscopic rectal cancer taTME from the one surgery team in different operation stages: three medical centers including the number 2, number 37 and number 39 medical center with close operation volume provided the clinical data of cases distributed in five operation stages. Among the five operation stages, the proportion of high-quality operation of total mesorectal excision (TME) was ≥17/18, the incidence of postoperative complications was ≤13.3%(4/30) and the incidence of anastomotic leakage was ≤10.0%(3/30). There was no significant difference in the TME quality, postoperative complications or anastomotic leakage among the five operation stages ( P>0.05). There was no significant difference in the operation time among the five operation stages ( χ2=6.950, P>0.05). (4) Learning curve of the one surgery team: the number of operations corresponding to the turning point of learning curve in number 2 and number 20 medical center was 22 and 39, respectively. The number of operations corresponding to the turning points of learning curve in number 33 and number 37 medical center was 15, 66 and 10, 28, respectively. The number of operations corresponding to the turning point of learning curve in number 39 medical center was 20. The overall curve of number 20 medical center was in line with the trend of learning curve and 39 cases of operations was the minimum number needed to cross the learning curve. The biggest difference in learning curve was shown between the number 20 and number 33 medical center. Cases with the gender of male or female, age, body mass index, cases classified as stage 1, stage 2, stage 3 or stage 4 of the American Society of Anesthesiologists (ASA) Classification, cases with neoadjuvant therapy, duration of postoperative hospital stay of the number 20 medical center were 77, 20, (60±10)years, 24 kg/m 2(22 kg/m 2, 26 kg/m 2), 1, 88, 8, 0, 8, 8, 11 days (9 days, 13 days), respectively, versus 51, 31, (64±11)years, 23 kg/m 2(21 kg/m 2, 26 kg/m 2), 0, 35, 43, 1, 31, 16 days (13 day, 21 day) of number 33 medical center, showing significant differences in the above indicators between the two medical centers ( χ2 =6.442, t=-2.265, Z=-2.032, -6.870, χ2 =22.120, Z=-8.408, P<0.05). (5) Clinical data collection of the two surgery teams: the clinical data of 259 patients undergoing laparoscopic rectal cancer taTME from 5 medical centers were collected, including 46 cases in the number 2 medical center, 47 cases in the number 8 medical center, 78 cases in the number 18 medical center, 43 cases in the number 33 medical center and 45 cases in the number 44 medical center, respectively. (6) Surgical situations of laparoscopic rectal cancer taTME from the two surgery teams: four medical centers including the number 2, number 8, number 33 and number 44 medical center with close operation volume provided the clinical data of cases distributed in four operation stages. Among the four operation stages, the proportion of high-quality operation of TME was ≥50.0%(13/26), the incidence of postoperative complications was ≤35.0%(14/40) and the incidence of anastomotic leakage was ≤22.5%(9/40). There was no significant difference in the TME quality, postoperative complications or operation time among the four operation stages ( χ2 =3.252, 4.733, 8.848, P>0.05). There was a significant difference in the incidence of anastomotic leakage among the four operation stages ( P<0.05). (7) Learning curve of the two surgery teams: the number of operations corresponding to the turning point of learning curve in number 2 and number 8 medical center was 28 and 16, respectively. The number of operations corresponding to the turning points of learning curve in number 18, number 33 and number 44 medical center was 12 and 58, 10 and 36, 14 and 36, respectively. The overall curve of number 2 medical center was in line with the trend of learning curve and 28 cases of operations was the minimum number needed to cross the learning curve. The biggest difference in learning curve was shown between the number 2 and number 33 medical center. The age and cases with tumor in stage T0 and (or) Tis, stage T1, stage T2, stage T3 or stage T4 of the T staging of the number 2 and number 33 medical center were (60±12)years, 3, 1, 9, 11, 20 and (65±10)years, 2, 3, 22, 15, 0, respectively, showing significant differences in the above indicators between the two medical centers ( t=-2.280, Z=-4.033, P<0.05). Conclusion:Thirty-nine cases of operations was the minimum number for the one surgery team to cross the learning curve of laparoscopic rectal cancer taTME and 28 cases of operations was the minimum number for the two surgery teams to cross the learning curve of laparoscopic rectal cancer taTME.
ABSTRACT
Transanal total mesorectal excision (taTME) is a hot topic surgical approach in the field of colorectal surgery. However, the therapeutic effect of this surgical approach is controversial. Based on the accumulated experience and evidence, the domestic and international consensus and guidelines on taTME have been updated and improved. The importance of taTME registry study is emphasized again in the 'International expert consensus guidance on indications, implementation and quality measures for transanal total mesorectal excision' published in 2020. The implementation of prospective case registration is the fundamental premise to ensure the quality of data and the advancing data collection methods and online platform construction can further improve the quality of data. Based on the latest taTME international consensus, the authors discuss the importance of case registry study to improve the data quality of taTME registry study and provide reliable and timeliness evidence based medicine in the field of colorectal surgery.
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Intracorporeal anastomosis in laparoscopic right hemicolectomy of colon cancer is becoming a hot spot in colorectal surgery. A number of retrospective studies have suggested that intracorporeal anastomosis has potential advantages in promoting postoperative recovery and reducing postoperative complications compared with conventional extracorporeal anastomosis. Several randomized controlled trials published recently have also confirmed that intracorporeal anastomosis can promote postoperative gastrointestinal function recovery and reduce postoperative pain, but there is still insufficient evidence to draw a conclusion about the incidence of complications, especially the anastomotic leakage rate. Heterogeneity of surgical techniques and unclear definition of anastomotic leakage are the main difficulties in current studies. Several high-quality prospective randomized controlled trials are currently under way, and high level of evidence is needed to objectively evaluate the laparoscopic right hemicolectomy of colon cancer. The authors review the relevant literatures at home and abroad, systematically elaborate the research status and prospects of digestive tract reconstruction after laparoscopic right hemicolectomy of colon cancer, in order to explore a new direction for the clinical research of colorectal surgery in China.
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Objective:To investigate the incidence and influencing factors of anastomotic leakage after anterior resection (AR) for rectal cancer.Methods:The retrospective case-control study was conducted. The clinicopathological data of 1 243 patients with rectal cancer who were admitted to 3 medical centers between August 2008 and July 2017 were collected, including 512 in the Beijing Friendship Hospital of Capital Medical University, 480 in the Cancer Hospital of Chinese Academy of Medical Sciences, 251 in the Peking University People′s Hospital. There were 734 males and 509 females, aged from 25 to 89 years, with an average age of 65 years. All patients underwent AR for rectal cancer. Observation indicators: (1) surgical situations and incidence of postoperative anastomotic leakage; (2) influencing factors for postoperative anastomotic leakage. Measurement data with skewed distribution were represented as M (range). Count data were represented as absolute numbers or percentages, and comparison between groups was analyzed using the chi-square test or Fisher exact probability. Univariate analysis was conducted using the chi-square test. Multivariate analysis was conducted using the Logistic regression model based on factors with P<0.10 in the univariate analysis. Results:(1) Surgical situations and incidence of postoperative anastomotic leakage: all the 1 243 patients with rectal cancer underwent successfully AR including 219 undergoing defunctioning stoma and 1 024 undergoing non-defunctioning stoma, of which 70 patients had postoperative anastomotic leakage, with a total incidence rate of 5.632%(70/1 243). The incidence rates of grade A anastomotic leakage, grade B anastomotic leakage, and grade C anastomotic leakage were 27.1%(19/70), 21.4%(15/70), 51.4%(36/70), respectively. (2) Influencing factors for postoperative anastomotic leakage: results of univariate analysis showed that gender, surgical procedure, volume of intra-operative blood loss, and pathological metastasis staging were related factors for anastomotic leakage after AR ( χ2=8.518, 6.548, 10.834, 4.501, P<0.05). Results of multivariate analysis based on factors with P<0.10 in the univariate analysis showed that male and volume of intraoperative blood loss≥100 mL were independent risk factors for anastomotic leakage after AR [ odds ratio ( OR)=2.250, 1.949, 95% confidence interval ( CI): 1.281-3.952, 1.142-3.324, P<0.05)]; defunctioning stoma was an independent protective factor for anastomotic leakage after AR ( OR=0.449, 95% CI: 0.201-1.001, P<0.05). Subgroup analysis on effects of defunctioning stoma versus non-defunctioning stoma on grade of anastomotic leakage showed that percentage of grade C anastomotic leakage for defunctioning stoma group was 14.3%(1/7), versus 55.6%(35/63) for non-defunctioning stoma group, with a significant difference between the two groups ( χ2=9.570, P<0.05). Conclusions:Male and volume of intraoperative blood loss≥100 mL are independent risk factors for anastomotic leakage after AR. Defunctioning stoma is an independent protective factor for anastomotic leakage after AR. For male patients and patients with large volume of intraoperative blood loss, defunctioning stoma is recommended to reduce the incidence of postoperative anastomotic leakage.
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China has the largest group of patients with colorectal cancer in the world,however,there are few international guidelines for the diagnosis and treatment of colorectal cancer from China,or research of high-level evidence in China.In recent years,colorectal surgery has developed rapidly in China,and great progress has been made both in clinical practice and in clinical research.But there are still many imbalances and under-regulations.In 2018,Chinese Society of Colorectal Surgery led the establishment of Chinese Colorectal Cancer Surgery Database (CCCD).The retrospective and prospective data collection coming from CCCD showed that the standardization of colorectal cancer surgery and data management needed to be improved,and the awareness of clinical research needed to be further improved.Therefore,how to carry out good clinical research and obtain high-level evidence based upon CCCD will be the great challenge for colorectal surgery in China.