1.Effect of side-to-end anastomosis on postoperative bowel function in rectal cancer surgery: a prospective single-center randomized controlled trial
Chang WANG ; Fan LIU ; Sen HOU ; Zhanlong SHEN ; Mujun YIN ; Xiaodong YANG ; Kewei JIANG ; Qiwei XIE ; Bin LIANG ; Kai SHEN ; Zhidong GAO ; Yingjiang YE
Chinese Journal of Gastrointestinal Surgery 2025;28(6):644-652
Objective:To compare bowel function 12 months after surgery between side-to-end anastomosis (SEA) and end-to-end anastomosis (EEA) groups of patients who had undergone rectal cancer resection.Methods:This single-center, prospective, open-label, phase III randomized controlled trial was approved by the Ethics Committee of Peking University People's Hospital (2018PHB040-01) and registered at ClinicalTrials. org (NCT03669237). Inclusion criteria were as follows: (1) histologically confirmed rectal adenocarcinoma; (2) tumor located 0 to 12 cm from the anal verge; (3) age≥18 years; and (4) planned R0 resection with primary reconstruction. Exclusion criteria included: (1) emergency surgery; (2) cognitive impairment; (3) non-primary anastomosis; (4) history of left-sided colonic or anorectal surgery; and (5) preexisting chronic defecation dysfunction. Eligible rectal cancer patients scheduled for elective sphincter-preserving surgery at Peking University People's Hospital were prospectively enrolled between October 2018 and March 2021 and randomly assigned to either the EEA group or the SEA group via computer-generated numbers prior to entering the operating room. All patients underwent standard radical tumor resection. Bowel function was evaluated by the low anterior resection syndrome (LARS) questionnaire. It consists of five single-choice questions and yields a total score ranging from 0 to 42. Defecation function is categorized into three levels: no LARS (0-20 points), minor LARS (21-29 points), and major LARS (30-42 points). The primary endpoint was the LARS score 12 months after surgery. Secondary endpoints included LARS scores from 1 to 11 months and during long-term follow-up(>12 months). The final follow-up was completed in July 2022. All randomized patients were included in the intention-to-treat set (ITTS). The full analysis set (FAS) was defined as ITTS patients with valid outcome data. All primary statistical analyses were performed in the FAS, and results were further compared in the per-protocol set (PPS) based on the actual treatment received.Results:A total of 323 patients underwent eligibility assessment, of whom 71 did not meet the inclusion criteria and 52 declined to participate. Ultimately, 200 patients were randomized. Median age was 64 years and 85 were women. The SEA and EEA groups comprised 102 and 98 patients, respectively. A total of 181 patients (90.5%) were included in the FAS, and 170 (85.0%) were included in the PPS. Among these, the 12-month LARS score was evaluated in 178 patients (98.3%) in the FAS and in 167 (98.2%) in the PPS. Median LARS score at 1–12 months were significantly lower in the SEA group in both the FAS dataset [12 months:8 (interquartile range [IQR], 0–22) vs. 14 (IQR, 8–29); Z=2.687, P=0.007] and the PPS dataset [12 months: 8 (IQR, 0–22) vs. 14 (IQR, 6–29); Z=2.543, P=0.011]. During long-term follow-up, the median LARS score was also significantly lower in the SEA group in the FAS dataset [2 (IQR, 0–4) vs. 11 (IQR, 2–23); Z=2.968, P=0.003] and the PPS dataset [2 (IQR, 0–14) vs. 11 (2, 27); Z=2.687, P=0.007]. Conclusion:Compared with the EEA group, bowel function was superior in the SEA group 1 year after surgery and during long-term follow-up.
2.Effect of side-to-end anastomosis on postoperative bowel function in rectal cancer surgery: a prospective single-center randomized controlled trial
Chang WANG ; Fan LIU ; Sen HOU ; Zhanlong SHEN ; Mujun YIN ; Xiaodong YANG ; Kewei JIANG ; Qiwei XIE ; Bin LIANG ; Kai SHEN ; Zhidong GAO ; Yingjiang YE
Chinese Journal of Gastrointestinal Surgery 2025;28(6):644-652
Objective:To compare bowel function 12 months after surgery between side-to-end anastomosis (SEA) and end-to-end anastomosis (EEA) groups of patients who had undergone rectal cancer resection.Methods:This single-center, prospective, open-label, phase III randomized controlled trial was approved by the Ethics Committee of Peking University People's Hospital (2018PHB040-01) and registered at ClinicalTrials. org (NCT03669237). Inclusion criteria were as follows: (1) histologically confirmed rectal adenocarcinoma; (2) tumor located 0 to 12 cm from the anal verge; (3) age≥18 years; and (4) planned R0 resection with primary reconstruction. Exclusion criteria included: (1) emergency surgery; (2) cognitive impairment; (3) non-primary anastomosis; (4) history of left-sided colonic or anorectal surgery; and (5) preexisting chronic defecation dysfunction. Eligible rectal cancer patients scheduled for elective sphincter-preserving surgery at Peking University People's Hospital were prospectively enrolled between October 2018 and March 2021 and randomly assigned to either the EEA group or the SEA group via computer-generated numbers prior to entering the operating room. All patients underwent standard radical tumor resection. Bowel function was evaluated by the low anterior resection syndrome (LARS) questionnaire. It consists of five single-choice questions and yields a total score ranging from 0 to 42. Defecation function is categorized into three levels: no LARS (0-20 points), minor LARS (21-29 points), and major LARS (30-42 points). The primary endpoint was the LARS score 12 months after surgery. Secondary endpoints included LARS scores from 1 to 11 months and during long-term follow-up(>12 months). The final follow-up was completed in July 2022. All randomized patients were included in the intention-to-treat set (ITTS). The full analysis set (FAS) was defined as ITTS patients with valid outcome data. All primary statistical analyses were performed in the FAS, and results were further compared in the per-protocol set (PPS) based on the actual treatment received.Results:A total of 323 patients underwent eligibility assessment, of whom 71 did not meet the inclusion criteria and 52 declined to participate. Ultimately, 200 patients were randomized. Median age was 64 years and 85 were women. The SEA and EEA groups comprised 102 and 98 patients, respectively. A total of 181 patients (90.5%) were included in the FAS, and 170 (85.0%) were included in the PPS. Among these, the 12-month LARS score was evaluated in 178 patients (98.3%) in the FAS and in 167 (98.2%) in the PPS. Median LARS score at 1–12 months were significantly lower in the SEA group in both the FAS dataset [12 months:8 (interquartile range [IQR], 0–22) vs. 14 (IQR, 8–29); Z=2.687, P=0.007] and the PPS dataset [12 months: 8 (IQR, 0–22) vs. 14 (IQR, 6–29); Z=2.543, P=0.011]. During long-term follow-up, the median LARS score was also significantly lower in the SEA group in the FAS dataset [2 (IQR, 0–4) vs. 11 (IQR, 2–23); Z=2.968, P=0.003] and the PPS dataset [2 (IQR, 0–14) vs. 11 (2, 27); Z=2.687, P=0.007]. Conclusion:Compared with the EEA group, bowel function was superior in the SEA group 1 year after surgery and during long-term follow-up.
3.Application of Nirmatrelvir/Ritonavir in Patients with Chronic Kidney Disease and SARS-CoV-2 Infection
Baoxian LIANG ; Xiaoyun PANG ; Kewei XIE ; Miaolin CHE ; Qin WANG
Herald of Medicine 2024;43(9):1440-1444
Severe acute respiratory syndrome coronavirus-2(SARS-CoV-2)infection is a new respiratory infectious disease.Patients with chronic kidney disease are at high risk of SARS-CoV-2 infection.Once they develop SARS-CoV-2 infection,the rate of progression to severe illness or even death is much higher than that of the general population.Nirmatrelvir/ritonavir significantly reduce the risk of severe illness and death in patients infected with SARS-CoV-2.In this paper,the dosing regimen and drug interaction of nirmatrelvir/ritonavir in patients with different stages of chronic kidney disease complicated with SARS-CoV-2 infection were reviewed to provide a reference for clinical rational medication for patients with chronic kidney disease.
4.Efficacy and safety of compound amino acid capsules in the treatment of malnutrition and calcium and phosphorus metabolism disorders in maintenance hemodialysis patients
Wangshu WU ; Minzhou WANG ; Ahui SONG ; Bingru ZHAO ; Jiayue LU ; Wenkai HONG ; Leyi GU ; Kewei XIE ; Renhua LU
Journal of Shanghai Jiaotong University(Medical Science) 2024;44(8):1023-1029
Objective·To explore the efficacy and safety of compound amino acid capsules in the treatment of malnutrition and calcium and phosphorus metabolism disorders in maintenance hemodialysis patients.Methods·In this prospective,randomized,controlled,single-center study,forty maintenance hemodialysis patients from Renji Hospital,Shanghai Jiao Tong University School of Medicine were randomly divided into two groups,the treatment group(n=21)and the control group(n=19).The treatment group was given oral compound amino acid capsules on the basis of regular hemodialysis treatment,while the control group received no special nutritional intervention.Serum albumin,prealbumin,hemoglobin,ferritin,calcium,phosphorus,1,25-(OH)2-D3 and intact parathyroid hormone levels were analyzed every 3 months,and the incidence of adverse events including death,cardio-cerebrovascular accidents and vascular access failure was recorded.The total follow-up period was 9 months.Results·Serum albumin and prealbumin in the treatment group at 6-month and 9-month were significantly higher than the baseline parameters(albumin,t=3.574,5.599,both P<0.05;prealbumin,t/Z=-2.485,2.921,both P<0.05).Albumin in the control group increased at 9-month with a lower amplification compared to the treatment group(t=3.877,P=0.001),while the difference of prealbumin showed no statistical significance during follow-up.Hemoglobin and serum ferritin in the treatment group started to increase at 3-month(hemoglobin,t=2.192;ferritin,t=2.994;both P<0.05).Phosphorus in treatment group decreased at 3-month and 9-month(t/Z=-2.743,-2.103,both P<0.05),while phosphorus in the control group remained relatively stable during the first 6 months and increased at 9-month(Z=-2.178,P=0.029).Calcium and 1,25-(OH)2-D3 in the treatment group at 3-month and 6-month were significantly higher than the baseline parameters(calcium,t=4.581,4.922,both P=0.000;1,25-(OH)2-D3 t/Z=4.504,-2.374,both P<0.05),while the increase in blood calcium in the control group was significantly smaller than that in the treatment group during the same period.1,25-(OH)2-D3 in the control group showed no significant improvement.There was no significant difference in intact parathyroid hormone level,incidence of adverse events and other laboratory examination results between the two groups.Conclusion·Compound amino acid capsules can ameliorate the nutrition status and regulate calcium and phosphorus metabolism effectively and safely in maintenance hemodialysis patients.
5.Culture and identification of parietal epithelial cells of Bowman′s capsule
Minzhou WANG ; Chenqi XU ; Lulin MIN ; Jiayue LU ; Xiajing CHE ; Renhua LU ; Kewei XIE ; Leyi GU
Chinese Journal of Nephrology 2022;38(6):536-542
Objective:To explore the isolation and culture methods of mouse parietal epithelial cells (PECs) of Bowman′s capsule, so as to provide a cell tool for further study.Methods:Mouse renal corpuscles were isolated by cell sieving combined with magnetic separation. After primary culture, identified parietal epithelial cells were induced to differentiate into podocytes. Immunofluorescence staining, real-time quantitative PCR and Western blotting were used to detect specific markers of parietal epithelial cells and podocytes.Results:Primary cultured PECs grew like paving stone and expressed Claudin-1 (PECs specific marker), CD133 (stem cell marker) and CD24 (stem cell marker), without the expression of tubular epithelial cell proteins, mesangial cell and podocyte specific proteins. Cultured to 6 generations in vitro, the PECs still expressed Claudin-1, CD133 and CD24. After incubated with differentiation medium, PECs were able to express podocyte markers WT-1 and Synaptopodin. Conclusion:The renal corpuscles are extracted by cell sieving combined with magnetic separation, and the mouse PECs successfully cultured in vitro can be induced to express podocytes′ markers.
6.Early functional and oncological outcomes of lateral prostate capsule sparing robot-assisted radical cystectomy-Orthotopic ileal neobladder
Tianxin LIN ; Jibiao LI ; Wang HE ; Hao LIU ; Kewei XU ; Wen DONG ; Hai HUANG ; Wenlian XIE ; Jian HUANG
Chinese Journal of Urology 2021;42(7):491-496
Objective:To investigate the experience and results of the modified lateral prostate capsule sparing robot-assisted radical cystectomy-orthotopic ileal neobladder (LPCS-RARC-OIN).Methods:From December 2018 to November 2020, 19 patients received LPCS-RARC-OIN by a single surgeon in Sun Yat-sen Memorial Hospital, Sun Yat-sen University. LPCS-RARC-OIN was performed on male patients with high-risk non-muscle-invasive bladder cancer or muscle-invasive bladder cancer cT 2N 0M 0 without tumour in the bladder neck or urethra, and prostate cancer was ruled out by MRI and serum PSA<2.5ng/ml. The average age was 57.6 years, the average IIEF-5 score was 20.4. Separating the prostatic adenoma and the lateral prostate capsule from the base to the apex of the prostate, and retaining the lateral prostate surgical capsule or lateral prostate capsule about 1-2mm thickness. Patients were followed up and urinary function, sexual function and oncological outcomes were recorded. Results:All 19 operations were finished successfully. The average operation time was 279.9 (225-345) min and average estimated blood loss was 88.9 (30-200) ml. The average postoperative hospital stays was 15.8 (9 -23) days. The average lymph node yields was 23.3 (11-42). All surgical margins were negative and no incidental prostate cancer was found. 2 weeks, 1 month, 3 months and 6 months after catheter removal, the daytime and nighttime continence were 42.1% (8/19)and 36.8% (7/19), 63.2% (12/19)and 63.2% (12/19), 78.9% (15/19) and 73.7% (14/19), 94.7% (18/19) and 89.5% (17/19), respectively. 3 months and 6 months after operation, the average IIEF-5 score was 7.2 and 10.1 points respectively. The average follow-up was 10.6 months (5.4-26.1 months)and no recurrence or distant metastasis was found in this study.Conclusions:LPCS-RARC-OIN could improve the urinary and sexual function in selected patients. However, the long-term follow up is needed for functional and oncological outcomes.
7.Clinical characteristics of esophageal reflux after total gastrectomy
Zhiyuan ZHENG ; Yancheng CUI ; Jing ZHANG ; Chao SHEN ; Yushi ZHOU ; Xin LIU ; Yingjiang YE ; Qiwei XIE ; Mujun YIN ; Xiaodong YANG ; Kewei JIANG ; Zhidong GAO ; Zhifeng WANG ; Lili ZHAO ; Shan WANG ; Bin LIANG
Chinese Journal of General Surgery 2021;36(4):267-271
Objective:To observe the clinical characteristics of esophageal reflux after total gastrectomy (ERATG), and to explore the mechanism of occurrence.Methods:Fourteen gastric cancer patients who underwent total gastrectomy were prospectively enrolled in this study. The postoperative symptoms were observed and recorded and 24 h MII-pH with pH monitoring was performed to investigate the characteristics of postoperative reflux.Results:After total gastrectomy patients were with different degrees of ERATG as heartburn, appetite loss, chest tightness and belching. The overall nature of ERATG is mainly weak acid, with a pH between 4 and 7. ERATG involved esophageal-jejunal anastomosis and a length of esophagus 7 cm above the anastomosis. Patients with typical reflux symptoms had a lower pH minimum in the upright position than those without typical symptoms[(4.76±0.71) vs.(5.68±0.37), t=2.866, P<0.05]. Patients with typical reflux symptoms had a higher frequency of reflux of mixed liquid and liquid-air reflux than those without typical symptoms[liquid(31.25±29.76) vs.(4.50±9.14), t=0.011, P<0.05; liquid-air(19.50±12.99) vs.(2.00±2.61), t=0.004, P<0.05]. Conclusion:ERATG is mainly a upward reflux of weakly acidic gas, with typical symptoms of heartburn, appetite loss, chest tightness and belching. Patients with typical symptoms usually have lower pH in the upright position.
8.Diagnostic value of tumor markers in peritoneal lavage fluid for peritoneal metastasis of colorectal cancer
Xin LIU ; Yushi ZHOU ; Qiwei XIE ; Mujun YIN ; Xiaodong YANG ; Kewei JIANG ; Zhiyuan ZHENG ; Bin LIANG ; Yingjiang YE ; Shan WANG
Chinese Journal of General Surgery 2020;35(8):593-597
Objective:To determine the diagnostic value of tumor markers in peritoneal lavage fluid from colorectal cancer patients for tumor peritoneal metastasis.Methods:A total of 227 colorectal cancer patients who undergoing surgical treatment were included. 300 ml of peritoneal lavage fluid was irrigated immediately upon laparotomy for traditional cytology (PLC) testing, 134 patients were tested for tumor marker of peritoneal lavage fluid (pTM). Univariate analysis was performed to determine the risk factors for peritoneal metastasis; pTM ROC curve was used to determine the best cutoff value; paired chi-square test was used to compare the difference between PLC and pTM detection.Results:The positive rate of PLC was 12.3% (28/227). Age>65, stage T3 + , lymph node metastasis, mucinous adenocarcinoma and increased serum CA125, CA19-9 are related to peritoneal metastasis; The best cutoff value of pTM for peritoneal metastasis : pCEA 17.095 ng/dl, sensitivity 58.3%, specificity 93.9%; pCA19-9 4.515 U/ml, sensitivity 83.3%, specificity 80.0%; pCA125 303.2 U/ml, sensitivity 58.3%, specificity 95.7%; pCA-724 3.01 U/ml, sensitivity 66.7%, specificity 95.7%; The best cutoff value of pTM for peritoneal micrometastasis: pCA19-9 3.43 U/ml, sensitivity 100%, specificity 72.2%. The positive rate of pCA19-9 was 29.85%, which was higher than that of PLC (χ 2=2.00, P<0.05). Conclusion:Peritoneal metastasis of colorectal cancer is related to tumor T stage, lymph node metastasis, tumor pathological type, and increased serum CA125 and CA19-9; pTM has diagnostic value for peritoneal metastasis of colorectal cancer.
9.Indocyanine green fluorescence imaging during laparoscopic anterior resection in rectal cancer patients
Jian CAO ; Yudi BAO ; Kewei JIANG ; Xiaodong YANG ; Mujun YIN ; Bin LIANG ; Qiwei XIE ; Shan WANG ; Zhanlong SHEN ; Yingjiang YE
Chinese Journal of General Surgery 2020;35(10):764-767
Objective:To investigate the role of indocyanine green(ICG) fluorescence imaging in laparoscopic anterior resection for rectal cancer.Methods:A retrospective analysis was performed on 7 patients who had undergone laparoscopic anterior resection with the use of ICG fluorescence imaging at Peking University People′s Hospital between Oct 2018 and Mar 2019. The clinicopathological variables, surgical factors, short-term outcome and complications were analyzed.Results:The median operation time was 185 min. The median estimated blood loss was 50 ml. The median time from ICG injection to anastomotic perfusion was 45 s. One patient received extended proximal resection of bowel due to poor perfusion as suggested by ICG imaging. The median time to soft diet was 4 days, and the median hospital stay was 8 days. The median number of lymph nodes harvested was 16. There were no major complications in all these patients. No adverse events related to ICG were recorded.Conclusions:ICG fluorescence imaging was safe and effective in detecting insufficient blood supply around newly established bowel anastomsis, hence potentially reducing the anastomotic leakage rate.
10.Comparative study of functional prognosis of transanal total mesorectal excision and conventional total mesorectal excision based on propensity score matching
Liyu ZHU ; Shidong ZHAO ; Zhanlong SHEN ; Yingjiang YE ; Mujun YIN ; Xiaodong YANG ; Qiwei XIE ; Kewei JIANG ; Bin LIANG ; Shan WANG
Chinese Journal of Surgery 2020;58(8):619-625
Objective:To compare the postoperative functional prognosis of transanal mesorectal excision (taTME) and conventional total mesorectal excision (TME) in rectal cancer.Methods:Totally 49 patients underwent taTME and 478 patients underwent conventional TME at Department of Gastroenterological Surgery, Peking University People′s Hospital from January 2015 to December 2019 were retrospectively collected. Propensity score matching method was used to perform 1 versus 1 matching between the taTME and conventional TME groups, and 36 pairs of patients were successfully matched. After matching, the median age of patients in taTME group and conventional TME group was 60.5 (16.0) years and 60.5 (13.0) years ( M( Q R)), respectively, and the proportion of male patients was 66.7% (24/36) and 55.6% (20/36) , respectively. EORTC QLQ-C30 scale was used to assess quality of life, low anterior resection syndrome (LARS) scale and Wexner constipation score were used to evaluate anal function, international prostate symptom score (IPSS) was used to evaluate urinary function,international index of erectile function (IIEF) -5 and female sexual function index (FSFI) score were used to evaluate male and female sexual function, respectively, and generalized anxiety disorder (GAD-7) and patient health questionnaire (PHQ-9) scale were used to evaluate psych function. The t test, Mann-Whitney U test, χ 2 test, and Fisher exact test were used for comparison between groups, and Wilcoxon rank sum test or McNemar test was used for comparison between paired data. Results:There were no significant differences in surgery time, postoperative hospital stays, conversion rate, morbidity rate, surgery cost, and numbers of lymph node yield between the two groups (all P>0.05). Compared with the conventional TME group, the intraoperative blood loss in the taTME group was significantly higher (100 (100) ml vs. 80 (50) ml, U=424.5, P=0.010), the prophylactic stoma rate was significantly higher (96.9%(31/36) vs. 63.6%(21/36), χ 2=11.218, P<0.01), the total hospitalization cost was significantly lower (74 297.7 (16 746.4) CNY vs. 91 781.3 (26 228.4) CNY, U=413.0, P=0.008). There were no significant differences in anal and urinary function between the two groups (LARS scalescore: Z=-0.513, P=0.608, Wexner constipation score: Z=-0.992, P=0.321, IPSS: Z=-1.807, P=0.071). In terms of psych function, significant difference in GAD-7 scale was seen between the two groups ( Z=-2.311, P=0.021), patients with generalized anxiety disorder accounting for 26.7% (8/30) and 46.9% (15/32), respectively. Conclusions:Compared with conventional TME surgery, taTME has a significantly increased blood loss and prophylactic stoma rate. There are no significant difference in the incidence of postoperative anal, urinary, and sexual dysfunction between taTME and conventinal TME. taTME can alleviate the financial burden and general anxiety disorder to a certain extent.

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