Short-term Outcomes of Laparoscopy-Assisted vs Open Surgery for Patients With Low Rectal Cancer: The LASRE Randomized Clinical Trial.

Importance: The efficacy of laparoscopic vs open surgery for patients with low rectal cancer has not been established. Objective: To compare the short-term efficacy of laparoscopic surgery vs open surgery for treatment of low rectal cancer. Design, Setting, and Participants: This multicenter, noninferiority randomized clinical trial was conducted in 22 tertiary hospitals across China. Patients scheduled for curative-intent resection of low rectal cancer were randomized at a 2:1 ratio to undergo laparoscopic or open surgery. Between November 2013 and June 2018, 1070 patients were randomized to laparoscopic (n = 712) or open (n = 358) surgery. The planned follow-up was 5 years. Data analysis was performed from April 2021 to March 2022. Interventions: Eligible patients were randomized to receive either laparoscopic or open surgery. Main Outcomes and Measures: The short-term outcomes included pathologic outcomes, surgical outcomes, postoperative recovery, and 30-day postoperative complications and mortality. Results: A total of 1039 patients (685 in laparoscopic and 354 in open surgery) were included in the modified intention-to-treat analysis (median [range] age, 57 [20-75] years; 620 men [59.7%]; clinical TNM stage II/III disease in 659 patients). The rate of complete mesorectal excision was 85.3% (521 of 685) in the laparoscopic group vs 85.8% (266 of 354) in the open group (difference, -0.5%; 95% CI, -5.1% to 4.5%; P = .78). The rate of negative circumferential and distal resection margins was 98.2% (673 of 685) vs 99.7% (353 of 354) (difference, -1.5%; 95% CI, -2.8% to 0.0%; P = .09) and 99.4% (681 of 685) vs 100% (354 of 354) (difference, -0.6%; 95% CI, -1.5% to 0.5%; P = .36), respectively. The median number of retrieved lymph nodes was 13.0 vs 12.0 (difference, 1.0; 95% CI, 0.1-1.9; P = .39). The laparoscopic group had a higher rate of sphincter preservation (491 of 685 [71.7%] vs 230 of 354 [65.0%]; difference, 6.7%; 95% CI, 0.8%-12.8%; P = .03) and shorter duration of hospitalization (8.0 vs 9.0 days; difference, -1.0; 95% CI, -1.7 to -0.3; P = .008). There was no significant difference in postoperative complications rate between the 2 groups (89 of 685 [13.0%] vs 61 of 354 [17.2%]; difference, -4.2%; 95% CI, -9.1% to -0.3%; P = .07). No patient died within 30 days. Conclusions and Relevance: In this randomized clinical trial of patients with low rectal cancer, laparoscopic surgery performed by experienced surgeons was shown to provide pathologic outcomes comparable to open surgery, with a higher sphincter preservation rate and favorable postoperative recovery. Trial Registration: ClinicalTrials.gov Identifier: NCT01899547.

Anorectal dysfunction in patients with mid-low rectal cancer after surgery: A pilot study with three-dimensional high-resolution manometry.

BACKGROUND: The quality of life in patients who develop low anterior resection syndrome (LARS) after surgery for mid-low rectal cancer is seriously impaired. The underlying pathophysiological mechanism of LARS has not been fully investigated. AIM: To assess anorectal function of mid-low rectal cancer patients developing LARS perioperatively. METHODS: Patients diagnosed with mid-low rectal cancer were included. The LARS score was used to evaluate defecation symptoms 3 and 6 mo after anterior resection or a stoma reversal procedure. Anorectal functions were assessed by three-dimensional high resolution anorectal manometry preoperatively and 3-6 mo after surgery. RESULTS: The study population consisted of 24 patients. The total LARS score was decreased at 6 mo compared with 3 mo after surgery (P < 0.05), but 58.3% (14/24) lasted as major LARS at 6 mo after surgery. The length of the high-pressure zone of the anal sphincter was significantly shorter, the mean resting pressure and maximal squeeze pressure of the anus were significantly lower than those before surgery in all patients (P < 0.05), especially in the neoadjuvant therapy group after surgery (n = 18). The focal pressure defects of the anal canal were detected in 70.8% of patients, and those patients had higher LARS scores at 3 mo postoperatively than those without focal pressure defects (P < 0.05). Spastic peristaltic contractions from the new rectum to anus were detected in 45.8% of patients, which were associated with a higher LARS score at 3 mo postoperatively (P < 0.05). CONCLUSION: The LARS score decreases over time after surgery in the majority of patients with mid-low rectal cancer. Anorectal dysfunctions, especially focal pressure defects of the anal canal and spastic peristaltic contractions from the new rectum to anus postoperatively, might be the major pathophysiological mechanisms of LARS.

Risk factors for perioperative complications in laparoscopic surgeries of retrorectal cystic lesions.

BACKGROUND: The incidence of retrorectal lesions is low, and no consensus has been reached regarding the most optimal surgical approach. Laparoscopic approach has the advantage of minimally invasive. The risk factors influencing perioperative complications of laparoscopic surgery are rarely discussed. AIM: To investigate the risk factors for perioperative complications in laparoscopic surgeries of retrorectal cystic lesions. METHODS: We retrospectively reviewed the medical records of patients who underwent laparoscopic excision of retrorectal cystic lesions between August 2012 and May 2020 at our hospital. All surgeries were performed in the general surgery department. Patients were divided into groups based on the lesion location and diameter. We analysed the risk factors like type 2 diabetes mellitus, hypertension, the history of abdominal surgery, previous treatment, clinical manifestation, operation duration, blood loss, perioperative complications, and readmission rate within 90 d retrospectively. RESULTS: Severe perioperative complications occurred in seven patients. Prophylactic transverse colostomy was performed in four patients with suspected rectal injury. Two patients underwent puncture drainage due to postoperative pelvic infection. One patient underwent debridement in the operating room due to incision infection. The massive-lesion group had a significantly longer surgery duration, higher blood loss, higher incidence of perioperative complications, and higher readmission rate within 90 d (P < 0.05). Univariate analysis, multivariate analysis, and logistic regression showed that lesion diameter was an independent risk factor for the development of perioperative complications in patients who underwent laparoscopic excision of retrorectal cystic lesions. CONCLUSION: The diameter of the lesion is an independent risk factor for perioperative complications in patients who undergo laparoscopic excision of retrorectal cystic lesions. The location of the lesion was not a determining factor of the surgical approach. Laparoscopic surgery is minimally invasive, high-resolution, and flexible, and its use in retrorectal cystic lesions is safe and feasible, also for lesions below the S3 level.

Neoadjuvant chemoradiotherapy might provide survival benefit in patients with stage IIIb/IIIc locally advanced rectal cancer: A retrospective single-institution study with propensity score-matched comparative analysis.

BACKGROUND: Neoadjuvant chemoradiotherapy (NACRT) and total mesorectal excision (TME) are standard treatments of stage II/III locally advanced rectal cancer (LARC), currently. Here, we evaluated the oncological outcomes in LARC patients treated with NACRT compared to TME alone, and determined whether tumor regression grade (TRG) and pathologic response after NACRT was related to prognosis. METHODS: This is a retrospective comparison of 358 LARC patients treated with either TME alone (non-NACRT group, n = 173) or NACRT plus TME (NACRT group, n = 185) during 2003-2013. Perioperative and oncologic outcomes, like overall survival (OS), disease-free survival (DFS) and recurrence were compared using 1:1 propensity score matching analysis. RESULTS: A total of 133 patients were matched for the analysis. After a median follow-up of 45 months (8-97 months), the 5-year OS (NACRT vs non-NACRT: 75.42% vs 72.76%; P = 0.594) and 5-year DFS (NACRT vs non-NACRT: 74.25% vs 70.13%; P = 0.224) were comparable between NACRT and non-NACRT, whereas the 5-year DFS rate was higher in the NACRT group when only stage IIIb/IIIc patients were considered (NACRT vs. non-NACRT: 74.79% vs. 62.29%; P = 0.056). In the NACRT group of 185 patients, those with pCR/stage I (vs stage II/stage III disease) or TRG3/TRG4 disease (vs TRG0/TRG1/TRG2) had significantly better prognosis. CONCLUSION: NACRT might provide survival benefit in patients with stage IIIb/IIIc locally advanced rectal cancer.

A single-center, prospective, randomized clinical trial to investigate the optimal removal time of the urinary catheter after laparoscopic anterior resection of the rectum: study protocol for a randomized controlled trial.

BACKGROUND: Urinary catheter placement is essential before laparoscopic anterior resection for rectal cancer. Whether early removal of the catheter increases the incidence of urinary retention and urinary tract infection (UTI) is not clear. This study aims to determine the optimal time for removal of the urinary catheter after laparoscopic anterior resection of the rectum. METHODS/DESIGN: A total of 220 participants meeting the inclusion criteria will be randomly assigned to an experimental group or a control group. The experimental group will have their urethral catheters removed on postoperative day 2 and the control group will have their urethral catheters removed on postoperative day 7. In both groups, catheter removal will be performed when the bladder is full. The incidence of urinary retention and UTI in the two groups will be compared to determine the optimal catheter removal time. DISCUSSION: This is a prospective, single-center, randomized controlled trial to determine whether early removal of the urinary catheter after laparoscopic anterior resection of the rectum will help to decrease the incidence of postoperative acute urinary retention and UTI. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03065855 . Registered on 23 February 2017.

Can Endorectal Ultrasound, MRI, and Mucosa Integrity Accurately Predict the Complete Response for Mid-Low Rectal Cancer After Preoperative Chemoradiation? A Prospective Observational Study from a Single Medical Center.

BACKGROUND: Patients with locally advanced rectal cancer could be managed by a watch-and-wait approach if they achieve clinical complete response after preoperative chemoradiotherapy. Mucosal integrity, endorectal ultrasound, and rectal MRI are used to evaluate clinical complete response; however, the accuracy remains questionable. Clinical practice based on those assessment methods needs more data and discussion. OBJECTIVE: The aim of this prospective study was to evaluate the accuracy of mucosal integrity, endorectal ultrasound, and rectal MRI to predict clinical complete response after chemoradiotherapy. DESIGN: Endorectal ultrasound and rectal MRI were undertaken 6 to 7 weeks after preoperative chemoradiation therapy. Patients then received radical surgery based on the principles of total mesorectal excision. Preoperative tumor staging achieved by endorectal ultrasound and rectal MRI was compared with postoperative staging by pathologic examination. Sensitivity, specificity, and accuracy of each evaluation method were calculated. SETTINGS: The study was conducted at a single tertiary care center. PATIENTS: Patients diagnosed with mid-low rectal cancer by biopsy between May 2014 and December 2016 were enrolled in this study. RESULTS: A total of 124 patients were enrolled in this study, and postoperative pathology revealed that 20 patients (16.13%) achieved complete response (ypT0N0). The sensitivity of mucosal integrity, endorectal ultrasound, and MRI to predict clinical complete response was 25%. The specificity of mucosal integrity, endorectal ultrasound, and MRI was 94.23%, 93.90%, and 93.27%. The combination of each 2 or all 3 methods did not improve accuracy. Regression analysis showed that none of these methods could predict postoperative ypT0. LIMITATIONS: The sample size is small, and we did not focus on the follow-up data and cannot compare prognosis data with previous research studies. CONCLUSIONS: Both single-method and combined mucosal integrity, endorectal ultrasound, and rectal MRI have poor correlation with postoperative pathologic examination. A watch-and-wait approach based on these methods might not be a proper strategy compared with radical surgery after neoadjuvant therapy. See Video Abstract at http://links.lww.com/DCR/A693.

Laparoscopic-Assisted Resection for Advanced Colorectal Cancer in Solid Organ Transplant Recipients.

AIM: To evaluate the feasibility, short- and long-term outcomes, and safety of laparoscopic resection for advanced colorectal cancer (CRC) in solid organ transplant recipients. METHODS: Between September 2001 and April 2016, five patients who underwent laparoscopic-assisted resection for CRC after solid organ transplantation were included in this study. Their clinical data were retrospectively analyzed with regard to patient demographics, immunosuppressive therapy, tumor characteristics, surgical outcomes, and follow-up data. RESULTS: Four kidney and one heart transplant recipients were included. Laparoscopic-assisted low anterior resection was performed in four patients with rectal or rectosigmoid junction cancer, and sigmoidectomy was done in one with sigmoid colon cancer. One kidney transplant patient received a protective loop transverse colostomy. All resections achieved complete tumor removal with tumor-free margins and total mesorectal excision, with an average number of 14 lymph nodes harvested. Most tumors were in stage III (n = 3), one was in stage II, and one in stage IV. The mean duration of surgery, intraoperative blood loss, and postoperative hospital stay were 144 min, 105 mL, and 8.8 days, respectively. No major complications occurred and graft function stayed well. During a mean follow-up period of 62 months, two patients developed metastasis and died eventually. CONCLUSION: Laparoscopic resection for advanced CRC in organ transplant recipients is technically feasible and therapeutically safe, and seems to have the advantages of few postoperative complications, short recovery time, and acceptable oncological outcomes.

A novel heterozygous germline deletion in MSH2 gene in a five generation Chinese family with Lynch syndrome.

Lynch syndrome (LS) is one of the most common familial forms of colorectal cancer predisposing syndrome with an autosomal dominant mode of inheritance. LS is caused by the germline mutations in DNA mismatch repair (MMR) genes including MSH2, MLH1, MSH6 and PMS2. Clinically, LS is characterized by high incidence of early-onset colorectal cancer as well as endometrial, small intestinal and urinary tract cancers, usually occur in the third to fourth decade of the life. Here we describe a five generation Chinese family with LS clinically diagnosed according to the Amsterdam II criteria. Immuno-histochemical staining of MSH2 and MSH6 shows only foci nuclear positive on the surface of the tumor with strong expression of MLH1 and PMS2 with diffuse immunoreactivity. In order to dig into the molecular basis of this LS pedigree, we collected the proband's blood sample, extracted the genomic DNA and applied the genetic screening. As a result, we identified a novel heterozygous deletion in MSH2 gene by targeted next generation sequencing, which is also proved to be co-segregated among other affected family members by following validation. To our knowledge, this novel heterozygous deletion (c.1676_1679 delTAAA) in MSH2 gene causes frameshift mutation (p.Asn560Lysfs*29) and leads to the formation of a truncated MSH2 protein which is confirmed to be a deleterious mutation according to the variant interpretation guidelines of American College of Medical Genetics and Genomics (ACMG). Identification of novel DNA mismatch repair (MMR) gene mutations can definitely benefit to the clinical diagnosis and management.

High expression of PTBP1 promote invasion of colorectal cancer by alternative splicing of cortactin.

Polypyrimidine tract-binding protein 1 (PTBP1) involving in almost all steps of mRNA regulation including alternative splicing metabolism during tumorigenesis due to its RNA-binding activity. Initially, we found that high expressed PTBP1 and poor prognosis was interrelated in colorectal cancer (CRC) patients with stages II and III CRC, which widely different in prognosis and treatment, by immunohistochemistry. PTBP1 was also upregulated in colon cancer cell lines. In our study, knockdown of PTBP1 by siRNA transfection decreased cell proliferation and invasion in vitro. Denovirus shRNA knockdown of PTBP1 inhibited colorectal cancer growth in vivo. Furthermore, PTBP1 regulates alternative splicing of many target genes involving in tumorgenesis in colon cancer cells. We confirmed that the splicing of cortactin exon 11 which was only contained in cortactin isoform-a, as a PTBP1 target. Knockdown of PTBP1 decreased the expression of cortactin isoform-a by exclusion of exon 11. Also the mRNA levels of PTBP1 and cortactin isoform-a were cooperatively expressed in colorectal cancer tissues. Knocking down cortactin isoform-a significantly decreased cell migration and invasion in colorectal cancer cells. Overexpression of cortactin isoform-a could rescue PTBP1-knockdown effect of cell motility. In summary the study revealed that PTBP1 facilitates colorectal cancer migration and invasion activities by inclusion of cortactin exon 11.

The Radical Extent of lymphadenectomy - D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) trial: study protocol for a randomized controlled trial.

BACKGROUND: The extent of lymphadenectomy during laparoscopic right colectomy can affect the oncological outcome and the safety of surgery. The principle of complete mesocolic excision (CME) has been gradually accepted and increasingly applied by colorectal surgeons. The aim of this study is to investigate whether extended lymphadenectomy (CME) in laparoscopic colectomy could improve the oncological outcomes of patients with right-sided colon cancers, compared with D2 lymphadenectomy. METHODS/DESIGN: The Radical Extent of lympadenectomy: D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) study is a prospective, multicenter, randomized controlled trial in which 1072 eligible patients with right-sided colon cancers will be randomly assigned to the CME group or the D2 dissection group during laparoscopic right colectomy. Inclusion criteria are locally advanced colon cancers situated from the cecum to the right third of the transverse colon and clinically staged as T2-4aN0M0 or TanyN + M0. The primary endpoint of this trial is 3-year disease-free survival. Secondary endpoints include 3-year overall survival, postoperative complication rates, perioperative mortality rates, and rates of positive central lymph nodes (the station 3 nodes). DISCUSSION: The RELARC trial is a prospective, multicenter, randomized controlled trial that will provide evidence on the optimal extent of lymphadenectomy during laparoscopic right colectomy in terms of better oncological outcome and operation safety. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02619942 . Registered on 29 November 2015.

Prognostic Superiority of Log Odds of Positive Lymph Nodes in Stage 3 Colorectal Cancer.

Objective To evaluate the prognostic value of the log odds of positive lymph nodes (LODDS) in stage 3 colorectal cancer (CRC) patients who have undergone curative resection. Methods We performed a retrospective review of 175 stage 3 CRC patients who underwent curative resection in Peking Union Medical College Hospital from 2005 to 2012. Patients were categorized respectively according to the AJCC/UICC N grade,the metastatic lymph node ratio (LNR),and the ratio of their LODDS. The relationship between the N grade,LNR,LODDS,and overall survival (OS) rates were assessed.Results The five-year disease-free survival (DFS) was significantly different among stage 3 CRC patients in different N grade (Χ(2)=33.1,P=0.000),LNR (Χ(2)=14.3,P=0.001),and LODDS (Χ(2)=14.9,P=0.001). Univariate analysis showed that TNM stage (Χ(2)=27.0,P=0.000),cancerous node(Χ(2)=3.6,P=0.040),N grade (Χ(2)=33.1,P=0.000),LNR (Χ(2)=14.3,P=0.001),and LODDS (Χ(2)=30.4,P=0.000) were related to OS. Multivariate analysis indicated that TNM stage (HR:1.84,95%CI:1.59～6.29,P=0.001) and LODDS classification (HR:1.34,95%CI:1.01～1.80,P=0.047) were independent prognostic factors for OS in stage 3 CRC patients. Conclusion LODDS is a good prognostic indicator in stage 3 CRC patients who have undergone curative resection.

Comparison of Transanal Endoscopic Microsurgery and Total Mesorectal Excision in the Treatment of T1 Rectal Cancer: A Meta-Analysis.

BACKGROUND: Transanal endoscopic microsurgery (TEM) for the treatment of early-stage rectal cancer has attracted attention due to its advantages of reduced surgical trauma, fewer complications, low operative mortality, rapid postoperative recovery and short hospital stay. However, there are still significant controversies regarding TEM for the treatment of rectal cancer, mainly related to the prognosis associated with this method. OBJECTIVE: This study sought to compare the efficacy of transanal endoscopic microsurgery (TEM) and total mesorectal excision (TME) for the treatment of T1 rectal cancer. METHODS: We searched the Cochrane Library, PubMed, Embase and CNKI databases. Based on the Cochrane Handbook for Systematic Reviews, we screened the trials, evaluated the quality and extracted the data. RESULTS: One randomized controlled trial (RCT) and six non-randomized controlled clinical trials (CCTs) were included in the meta-analysis (a total of 860 rectal cancer patients were included; 303 patients were treated with TEM, and 557 patients were treated with TME). Analysis revealed that all seven studies reported local recurrence rates, and there was a significant difference between the TEM and TME groups [odds ratio (OR) = 4.62, 95% confidence interval (CI) (2.03, 10.53), P = 0.0003]. A total of five studies reported distant metastasis rates, and there was no significant difference between the TEM and TME groups [OR = 0.74, 95%CI (0.32, 1.72), P = 0.49]. A total of six studies reported postoperative overall survival of the patients, and there was no significant difference between the TEM and TME groups [OR = 0.87, 95%CI(0.55, 1.38), P = 0.55]. In addition, two studies reported the postoperative disease-free survival rates of patients, and there was no significant difference between the TEM and TME groups [OR = 1.12, 95%CI (0.31, 4.12), P = 0.86]. CONCLUSIONS: For patients with T1 rectal cancer, the distant metastasis, overall survival and disease-free survival rates did not differ between the TEM and TME groups, although the local recurrence rate after TEM was higher than that after TME.

Full-thickness excision using transanal endoscopic microsurgery for treatment of rectal neuroendocrine tumors.

AIM: To assess the efficacy of full-thickness excision using transanal endoscopic microsurgery (TEM) in the treatment of rectal neuroendocrine tumors. METHODS: We analyzed the data of all rectal neuroendocrine tumor patients who underwent local full-thickness excision using TEM between December 2006 and December 2014 at our department. Data collected included patient demographics, tumor characteristics, operative details, postoperative outcomes, pathologic findings, and follow-ups. RESULTS: Full-thickness excision using TEM was performed as a primary excision (n = 38) or as complete surgery after incomplete resection by endoscopic polypectomy (n = 21). The mean size of a primary tumor was 0.96 ± 0.21 cm, and the mean distance of the tumor from the anal verge was 8.4 ± 1.4 cm. The mean duration of the operation was 57.6 ± 13.7 min, and the mean blood loss was 13.5 ± 6.6 mL. No minor morbidities, transient fecal incontinence, or wound dehiscence was found. Histopathologically, all tumors showed typical histology without lymphatic or vessel infiltration, and both deep and lateral surgical margins were completely free of tumors. Among 21 cases of complete surgery after endoscopic polypectomy, 9 were histologically shown to have a residual tumor in the specimens obtained by TEM. No additional radical surgery was performed. No recurrence was noted during the median of 3 years' follow-up. CONCLUSION: Full-thickness excision using TEM could be a first surgical option for complete removal of upper small rectal neuroendocrine tumors.

Resection of multiple rectal carcinoids with transanal endoscopic microsurgery: case report.

Multiple rectal carcinoids are rare. Due to the unreliability of endoscopic polypectomy in treating these submucosal lesions, a laparotomy is usually performed. We present a case report on multiple rectal carcinoids with three carcinoid foci<10 mm in diameter located in the mid-rectum. Preoperative examination showed the lesions to be confined to the submucosal layer with no perirectal nodal involvement. A transanal endoscopic microsurgery was successfully performed to remove the three lesions with accurate full-thickness resection followed by secured suture closure. The postoperative pathology revealed neuroendocrine tumors G1 (carcinoids) located within the submucosal layer without lymphatic or vessel infiltration. Both the deep and lateral surgical margins were completely free of tumor cells. The patient recovered quickly and uneventfully. No tumor recurrence was observed at the six-month follow-up. For the multiple small rectal carcinoids without muscularis propria or lymphatic invasion, transanal endoscopic microsurgery offers a reliable and efficient alternative approach to traditional laparotomy for select patients, with the added advantages of minimally invasive surgery.

Ectopic variceal bleeding from colonic stoma: two case reports.

Parastomal variceal bleeding is a rare complication of portal hypertension, which often occurs in a recurrent manner and might be life-threatening in extreme situations. Treatment options vary, and no standard therapy has been established. Herein, we report 2 such cases. The first patient suffered from parastomal variceal bleeding after Hartmann procedure for rectal cancer. Stomal revision was performed, but bleeding recurred 1 month later. The second patient developed the disease after Miles procedure for rectal cancer. Embolization via the percutaneous transhepatic approach was performed using the Onyx liquid embolic system (LES) (Micro Therapeutics Inc, dba ev3 Neurovascular) in combination with coils, and satisfactory results were obtained after a 4-month follow-up. Our cases illustrate that surgical revision should be used with caution as a temporary solution due to the high risk of rebleeding, whereas transhepatic embolization via the Onyx LES and coils could be considered a safe and effective choice for skillful managers.

Ertapenem prophylaxis of surgical site infections in elective colorectal surgery in China: a multicentre, randomized, double-blind, active-controlled study.

OBJECTIVES: Our purpose was to evaluate ertapenem versus ceftriaxone/metronidazole for prophylaxis of surgical site infections (SSIs) following elective colorectal surgery in Chinese adult patients. METHODS: Eligible Chinese adults aged 18-80 years scheduled to undergo elective colorectal surgery by laparotomy were randomized to receive a 30 min infusion of 1 g of ertapenem/metronidazole placebo or 2 g of ceftriaxone/500 mg of metronidazole within 2 h before initial incision. The study endpoint was the proportion of patients with successful prophylaxis at 4 weeks after treatment. The primary analysis was based on the evaluable population (PP population) and the pre-specified non-inferiority margin was set at -15%. ClinicalTrials.gov: NCT01254344. RESULTS: Of 599 patients randomized, 499 (251 ertapenem and 248 ceftriaxone) were eligible for inclusion in the PP population. The proportions of patients with successful prophylaxis in the ertapenem and ceftriaxone groups were 90.4% (227/251) and 90.3% (224/248), respectively. The difference in the proportion of successful outcomes was 0.1% (95% CI -5.2%, 5.5%). Unexplained antibiotic use was the most frequent reason for prophylaxis failure in both groups [ertapenem 4.8% (12/251), ceftriaxone 4.4% (11/248); difference 0.3%; 95% CI -3.6, 4.3]. Pathogen species isolated from SSI sources were consistent with previously conducted studies and the product package insert. The incidence of adverse events (AEs) was similar between the groups, with the most common AE being pyrexia [ertapenem 7.6% (22/290), ceftriaxone 5.7% (17/297)]. CONCLUSIONS: Ertapenem is as effective as ceftriaxone/metronidazole for SSI prophylaxis in patients undergoing elective colorectal surgery, and is well tolerated.

[Three major problems and solutions in laparoscopic abdominoperineal resection for rectal carcinoma].

OBJECTIVE: To investigate the three major problems and solutions in laparoscopic abdominoperineal resection(APR) for rectal carcinoma. METHODS: A retrospective study of 60 low rectal carcinoma cases undergoing selective laparoscopic APR from September 2010 to May 2013 in our hospital was undertaken. A laparoscopic sigmoid stoma was performed through the extraperitoneal route at the left lower abdomen puncture point after lymphadenectomy and tumor excision during operation. Using the unique intracorporeal suture technique of transanal endoscopic microsurgery(TEM), the pelvic peritoneum was closed by continuous suture with TEM needle-forceps and absorbable suture. Those patients with the successful pelvic peritoneum closure received continuous irrigation of presacral space from the third postoperative day to prevent perineal incision infection. RESULTS: Only one patient (1.7%) was converted to laparotomy. Fifty-nine patients underwent laparoscopic APR and laparoscopic sigmoid stoma was successfully performed through the extraperitoneal route without abdominal incision, and the incidence of stoma complication was only 3.4%. Out of 59 patients undergoing laparoscopic APR, the pelvic peritoneum of 56 patients(94.9%) was closed successfully. The median time of closing the pelvic peritoneum was 15 min. Fifty-seven patients with pelvic peritoneum successfully closed by laparotomy or laparoscopic approach received continuous irrigation of presacral space and the median time of presacral drainage tube placement was 7.8 days. No patient developed postoperative intestinal obstruction. The rate of perineal wound healing in grade A, B and C was 87.7%, 8.8% and 3.5%, respectively. In the 3 patients whose pelvic peritoneum failed to be closed with simple drainage of presacral space, one developed postoperative intestinal obstruction and one had a grade C perineal wound healing. CONCLUSIONS: Laparoscopic sigmoid stoma through the extraperitoneal route during laparoscopic APR for rectal carcinoma is feasible and safe. It is convenient and effective to close pelvic peritoneum by using TEM intracorporeal suture technique. It is worth discussing the role of continuous irrigation of presacral space postoperatively to prevent perineal incision infection.

Clinical outcome of neoadjuvant chemoradiation therapy with oxaliplatin and capecitabine or 5-fluorouracil for locally advanced rectal cancer.

BACKGROUND AND OBJECTIVES: This study evaluated the safety and efficiency of preoperative chemoradiation therapy (CRT) with the XELOX or FOLFOX regimen in locally advanced rectal cancer patients. METHODS: One hundred forty-four patients (T3/T4 or N+) were enrolled between 2005 and 2011. The patients received preoperative concomitant CRT (XELOX or FOLFOX regimen). Patients were divided into four groups: pCR (pT0N0), downstaging, no-downstaging, and progression group. Clinical outcome with overall survival (OS) and disease-free survival (DFS) were compared for each group. RESULTS: One hundred thirty-eight patients received radical resection after preoperative CRT. Twenty-seven patients (20%) achieved pCR. The response rate (pCR + downstaging) was 67%. The most common side effects were nausea (64%), diarrhea (49%), and leucopenia (49%). The overall estimated 5-year OS was 86% for all patients. The estimated 5-year OS was significantly better in the responders (pCR + downstaging) than the non-responders (no-downstaging + progression, 94% vs. 68%, P = 0.001). There was also statistical difference in 3-year DFS between the two groups (93% vs. 68%, P = 0.000). CONCLUSIONS: pCR and downstaging after neoadjuvant CRT are associated with improved survival for locally advanced rectal cancer patients. Preoperative CRT with the XELOX or FOLFOX regimen is well tolerated and has mild adverse events.

[Expression of hMLH1 in rectal intraepithelial neoplasm and early rectal carcinoma].

OBJECTIVE: To explore whether the abnormality of hMLH1 gene may be an early event of carcinogenesis in rectal carcinoma, and to evaluate the diagnostic value in differentiation between intraepithelial neoplasm and early stage of colorectal carcinoma. METHODS: The expression of hMLH1 protein in 28 cases with early invasive rectal carcinoma(EIRC), 36 cases with rectal intraepithelial neoplasm(RIEN), and 30 cases with normal rectal mucosa(NRM) which were collected through surgical operations were detected by PV-9000 immunohistochemical method. RESULTS: The positive expression rates of hMLH1 protein were 100%(30/30), 77.8%(28/36), and 39.3%(11/28) in NRM, RIEN, and EIRC respectively. The difference was statistically significant between RIEN and EIRC(P=0.002), and the difference was also statistically significant between RIEN and NRM(P=0.006). The positive expression of hMLH1 was not related to age, gender, tumor maximum diameter, dysplasia, tumor types, and distance from the anal verge in RIEV group(P>0.05). In EIRC group, hMLH1 was associated with tumor differentiation(P<0.05). CONCLUSION: hMLH1 gene deletion may be an early event during carcinogenesis of rectal carcinoma, which may be useful in differentiation of intraepithelial neoplasm from early rectal carcinoma.

[Transanal endoscopic microsurgery for rectal cancer].

In comparison with the radical resection for rectal cancer, the local excision of rectal cancer is associated with advantages of less trauma, lower risks, anal sphincter preservation, and sexual and urinary function preservation. Being one of the local excision techniques for rectal cancers, transanal endoscopic microsurgery(TEM) becomes increasingly prevailing worldwide in recent years. As compared to traditional local excision procedures, TEM has been proven to improve the operative exposure and provide more adequate operating space. In addition, the TEM is equipped with multiple well-crafted surgical instruments that offer superior performances, which allows delicate surgical dissection and precise tumor excision. TEM provides surgeons with perfect technical support to decrease the chance of or to prevent insufficient removal of the lesion, which leaves an unsafe or positive surgical margin. Good therapeutic results are based on the accurate preoperative evaluation and careful selection of the patient, as well as strict adherence to the indications of this procedure. The best indications for TEM procedure include rectal adenomas with high-grade dysplasia (Tis stage), medium- or low-risk T1 rectal cancers, and cancers that only infiltrate into the Sm1 and Sm2 layers of the submucosa. Patients of T2 and T3 rectal cancers acquiring marked tumor downstaging (or tumor size decreases by more than 50%) after the neoadjuvant therapy may also be candidates for TEM local excision in clinical research studies. TEM technique enables a locally radical excision of the lesion, which is the key to prevent the postoperative recurrence.