Plastic Wound Protector vs Surgical Gauze for Surgical Site Infection Reduction in Open GI Surgery: A Randomized Clinical Trial.

Importance: Surgical site infections (SSIs) are prevalent hospital-acquired infections with significant patient impacts and global health care burdens. The World Health Organization recommends using wound protector devices in abdominal surgery as a preventive measure to lower the risk of SSIs despite limited evidence. Objective: To examine the efficacy of a dual-ring, plastic wound protector in lowering the SSI rate in open gastrointestinal (GI) surgery irrespective of intra-abdominal contamination levels. Design, Setting, and Participants: This multicenter, patient-blinded, parallel-arm randomized clinical trial was conducted from August 2017 to October 2022 at 13 hospitals in an academic setting. Patients undergoing open abdominal bowel surgery (eg, for bowel perforation) were eligible for inclusion. Intervention: Patients were randomized 1:1 to a dual-ring, plastic wound protector to protect the incision site of the abdominal wall (experimental group) or a conventional surgical gauze (control group). Main Outcomes and Measures: The primary end point was the rate of SSI within 30 days of open GI surgery. Results: A total of 458 patients were randomized; after 1 was excluded from the control group, 457 were included in the intention-to-treat analysis (mean [SD] age, 58.4 [12.1] years; 256 [56.0%] male; 341 [74.6%] with a clean-contaminated wound): 229 in the wound protector group and 228 in the surgical gauze group. The overall SSI rate in the intention-to-treat analysis was 15.7% (72 of 458 patients). The SSI rate for the wound protector was 10.9% (25 of 229 patients) compared with 20.5% (47 of 229 patients) with surgical gauze. The wound protector significantly reduced the risk of SSI, with a relative risk reduction (RRR) of 46.81% (95% CI, 16.64%-66.06%). The wound protector significantly decreased the SSI rate for clean-contaminated wounds (RRR, 43.75%; 95% CI, 3.75%-67.13%), particularly for superficial SSIs (RRR, 42.50%; 95% CI, 7.16%-64.39%). Length of hospital stay was similar in both groups (mean [SD], 15.2 [10.5] vs 15.3 [10.2] days), as were the overall postoperative complication rates (20.1% vs 18.8%). Conclusions and Relevance: This randomized clinical trial found a significant reduction in SSI rates when a plastic wound protector was used during open GI surgery compared with surgical gaze, supporting the World Health Organization recommendation for use of wound protector devices in abdominal surgery. Trial Registration: ClinicalTrials.gov Identifier: NCT03170843.

Concurrent ascending colon adenocarcinoma and ileocecal tuberculosis: A case report.

RATIONALE: Few cases have been reported of the coexistence of tuberculosis and adenocarcinoma of the large bowel. We report a rare case of concurrent ascending colon adenocarcinoma and ileocecal tuberculosis, which were nearly indistinguishable from one another. PATIENT CONCERNS: A 59-year-old man visited our clinic with dizziness and anorexia. DIAGNOSIS: Computed tomography revealed a mass in the ascending colon with ill-defined nodules in the liver. A colon biopsy showed adenocarcinoma with multinucleated giant cells. The liver nodules were confirmed to be metastatic adenocarcinomas. INTERVENTIONS: Ant tuberculosis medications were administered prior to surgery. Two weeks later, a laparoscopic right hemicolectomy and radiofrequency ablation of the liver were performed. OUTCOMES: The final pathology confirmed adenocarcinoma with chronic granulomatous inflammation and giant cells. LESSONS: In this patient, the cancer was in an advanced stage and had no history of tuberculosis infection. Thus, in this case, the malignancy seemed to create the proper environment for either reactivation of a latent tuberculosis infection or, less likely, for the acquisition of a primary mycobacterial infection. In conclusion, clinicians should be aware of the possibility of concurrent colon adenocarcinoma and intestinal tuberculosis.

Guidelines for accreditation of endoscopy units: quality measures from the Korean Society of Coloproctology.

PURPOSE: Colonoscopy is an effective method of screening for colorectal cancer (CRC), and it can prevent CRC by detection and removal of precancerous lesions. The most important considerations when performing colonoscopy screening are the safety and satisfaction of the patient and the diagnostic accuracy. Accordingly, the Korean Society of Coloproctology (KSCP) herein proposes an optimal level of standard performance to be used in endoscopy units and by individual colonoscopists for screening colonoscopy. These guidelines establish specific criteria for assessment of safety and quality in screening colonoscopy. METHODS: The Colonoscopy Committee of the KSCP commissioned this Position Statement. Expert gastrointestinal surgeons representing the KSCP reviewed the published evidence to identify acceptable quality indicators and indicators that lacked sufficient evidence. RESULTS: The KSCP recommends an optimal standard list for quality control of screening colonoscopy in the following 6 categories: training and competency of the colonoscopist, procedural quality, facilities and equipment, performance indicators and auditable outcomes, disinfection of equipment, and sedation and recovery of the patient. CONCLUSION: The KSCP recommends that endoscopy units performing CRC screening evaluate 6 key performance measures during daily practice.

Circular pOlyethylene drape in preVEntion of suRgical site infection (COVER trial): study protocol for a randomised controlled trial.

INTRODUCTION: Surgical site infection (SSI) after abdominal surgery remains a significant cause of morbidity and is associated with an increased socioeconomic burden and a reduced quality of life. Circular wound protectors have been expected to reduce the risk of SSI, but previous studies reported conflicting results on their protective effects. The purpose of this study was to evaluate the efficacy of circular wound protectors in reducing SSI in open abdominal surgery. METHODS AND ANALYSIS: The circular pOlyethylen drape in preVEntion of suRgical site infection (COVER) trial investigates whether the application of a dual-ring circular plastic wound protector reduces the rate of SSI in patients undergoing elective or emergent open abdominal surgery related to the gastrointestinal tract, regardless of the type of wound classified by the Centers for Disease Control. The COVER trial is a multicentre, randomised controlled clinical trial with two parallel arms-one using a dual-ring wound protector with circular polyethylene drape and the other using conventional surgical dressing gauze. The primary outcome will measure the rate of SSI within 30 days after surgery in two groups. Statistical analysis of the primary end point will be based on the intention-to-treat population. The sample size was determined to achieve a study power of 80% with 95% two-sided confidence limits. Considering a dropout rate of up to 5%, a total of 458 patients, 229 patients in each group, will be enrolled in this study. ETHICS AND DISSEMINATION: The trial protocol and informed consent document have been reviewed and approved by the institutional review board at each participating centre. Written informed consent will be obtained from each study participant. The clinical outcomes of this trial will be submitted to an international peer-reviewed journal and presented at international conferences. TRIAL REGISTRATION NUMBER: NCT03170843.

Efficacy and Safety of Ramosetron Injection for Nausea and Vomiting in Colorectal-Cancer Patients Undergoing a Laparoscopic Colectomy: A Randomized, Double-Blind, Comparative Study.

PURPOSE: A laparoscopic colectomy in colorectal-cancer patients is usually associated with a high risk of postoperative nausea and vomiting (PONV). The purpose of this study is to evaluate the efficacy of injection of long-acting 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist for the reduction of PONV in patients with colorectal cancer. METHODS: A total of 48 patients scheduled to undergo a laparoscopic colectomy for colorectal cancer were randomized in a double-blinded fashion. Patients were randomly allocated to 1 of 2 groups and assigned to receive either 0.3 mg of ramosetron intravenously (group A, n = 25) or 2 mL of normal saline (placebo) (group B, n = 22) immediately after the operation. The incidence of PONV, the nausea severity scale score, the visual analogue scale (VAS) score for pain, the total amount of patient-controlled analgesia used, the recovery of bowel function, and morbidities were assessed at 1 hour and at 24, 48, and 72 hours after surgery. RESULTS: The baseline and the operative characteristics were similar between the groups (P > 0.05). The number of cases without PONV (complete response) was higher for group A (ramosetron) than group B (normal saline): 24 hours after surgery, 92.0% (23 of 25) for group A versus 54.5% (12 of 22) for group B; 48 hours after surgery, 92% (23 of 25) for group A versus 81.8% (18 of 22) for group B (both P < 0.05). No serious adverse events occurred. CONCLUSION: Postoperative ramosetron injection is effective for the prevention of PONV after a laparoscopic colectomy in colorectal-cancer patients.

Long-term oncologic outcomes of laparoscopic surgery for splenic flexure colon cancer are comparable to conventional open surgery.

PURPOSE: Few studies about laparoscopic surgery for splenic flexure colon cancer have been published. This study aims to compare the short- and long-term outcomes of laparoscopic surgery for splenic flexure colon cancer with those of conventional open surgery. METHODS: From January 2004 to December 2010, 51 consecutive patients who underwent curative resection for stages I-III splenic flexure colon cancer were enrolled. Thirty-three patients underwent laparoscopy-assisted colectomy, while 18 patients underwent conventional open colectomy. Short- and long-term outcomes of the 2 groups were compared. RESULTS: There were no differences in baseline characteristics, intra- and postoperative complications. The laparoscopy group showed longer operation time (median [interquartile range, IQR]: 295.0 [255.0-362.5] minutes vs. 180.0 [168.8-206.3] minutes, P < 0.001). In the laparoscopy group, return of bowel function was faster (median [IQR]: 3 [2-4] vs. 4 [3-5], P = 0.007) and postoperative hospital stay was shorter (median [IQR]: 9 [8-11] vs. 10.5 [9-19], P = 0.026). There were no statistically significant differences in overall survival rate (84.3% vs. 76.0%, P = 0.560) or disease-free survival rate (93.8% vs. 74.5%, P = 0.078) between the 2 groups. CONCLUSION: Laparoscopic surgery for splenic flexure colon cancer has better short-term outcomes than open surgery, as well as acceptable long-term outcomes. Laparoscopic surgery can be a safe and feasible alternative to conventional open surgery for splenic flexure colon cancer.

Outcome of bridge to surgery stenting for obstructive left colon cancer.

BACKGROUND: The aim of our study was to compare short- and long-term outcomes of stent insertion followed by surgery with those of emergency surgery for left colon malignant obstructions. METHODS: The medical records of patients who received curative resection due to obstructive primary left colon cancer and who were diagnosed with stage II or III from January 2004 to December 2010 in six hospitals affiliated with The Catholic University of Korea were reviewed. One hundred and twelve patients in self-expandable metallic stent (SEMS) group were matched to 56 patients in the emergency surgery (ES) group using propensity score matching method. Overall survival (OS) and disease-free survival (DFS) were compared between the groups. Perioperative outcomes and pathologic results were also compared. RESULTS: Baseline characteristics were comparable between the two groups after matching. The analysis of perioperative outcomes showed short-term advantages of stent insertion. Patients in the SEMS group were more likely (87.5 versus 75.0%, P = 0.049) to have a distal resection margin >5 cm. Harvesting ≥12 lymph nodes were more frequent (89.3 versus 71.4%, P = 0.007) in the SEMS group. Five-year DFS was 69.5% in the SEMS group and 73.1% in the ES group (P = 0.464). Five-year OS was not different between the groups (79.7 versus 77.7%, P = 0.989). CONCLUSIONS: SEMS can be a reasonable therapeutic option for malignant obstruction in patients with left colon cancer until definitive conclusion about the long-term survival effect of SEMS is made from further large-scale prospective randomized trials.

α-Synuclein in the colon and premotor markers of Parkinson disease in neurologically normal subjects.

Extranigral non-motor signs precede the first motor manifestations of Parkinson's disease by many years in some patients. The presence of α-synuclein deposition within colon tissues in patients with Parkinson's disease can aid in identifying early neuropathological changes prior to disease onset. In the present study, we evaluated the roles of non-motor symptoms and signs and imaging biomarkers of nigral neuronal changes and α-synuclein accumulation in the colon. Twelve subjects undergoing colectomy for primary colon cancer were recruited for this study. Immunohistochemical staining for α-synuclein in normal and phosphorylated forms was performed in normally appearing colonic tissue. We evaluated 16 candidate premotor risk factors in this study cohort. Among them, ten subjects showed positive immunostaining with normal- and phosphorylated-α-synuclein. An accumulation of premotor markers in each subject was accompanied with positive normal- and phosphorylated-α-synuclein immunostaining, ranging from 2 to 7 markers per subject, whereas the absence of Lewy bodies in the colon was associated with relative low numbers of premotor signs. A principal component analysis and a cluster analysis of these premotor markers suggest that urinary symptoms were commonly clustered with deposition of peripheral phosphorylated-α-synuclein. Among other premotor marker, color vision abnormalities were related to non-smoking. This mathematical approach confirmed the clustering of premotor markers in preclinical stage of Parkinson's disease. This is the first report showing that α-synuclein in the colon and other premotor markers are related to each other in neurologically normal subjects.

IgG4-related disease of the rectum.

IgG4-related disease is a relatively new disease entity characterized by elevated serum IgG4 levels and marked infiltration of IgG4-positive plasma cells in lesions. Organ enlargement or nodular lesions consisting of abundant infiltration of lymphocytes and IgG4-positive plasma cells and fibrosis are seen in various organs throughout. We encountered a patient with an inflammatory pseudotumor of the rectum, which was histopathologically confirmed to be an IgG4-related disease. The patient was a 28-year-old woman who had constipation for 3 months. The endoluminal ultrasonography showed a lesion that was heterogeneous and low echogenic in lower rectum. The result of colonoscopic biopsy findings was of chronic proctitis with lymphoid aggregates. For a confirmative diagnosis, excision was performed. Histopathological examination represented plasma cell infiltration and fibrosis. Immunohistochemistry revealed prominence of IgG4-positive plasma cells and confirmed the diagnosis of IgG4-related disease. The patient is currently under observation on low-dose oral prednisolone without relapse.

Predictive microRNAs for lymph node metastasis in endoscopically resectable submucosal colorectal cancer.

Accurate prediction of regional lymph node metastasis (LNM) in endoscopically resected T1-stage colorectal cancers (CRCs) can reduce unnecessary surgeries. To identify miRNA markers that can predict LNM in T1-stage CRCs, the study was conducted in two phases; (I) miRNA classifier construction by miRNA-array and quantitative reverse transcription PCR (qRT-PCR) using 36 T1-stage CRC samples; (II) miRNA classifier validation in an independent set of 20 T1-stage CRC samples. The expression of potential downstream target genes of miRNAs was assessed by immunohistochemistry. In the discovery analysis by miRNA microarray, expression of 66 miRNAs were significantly different between LNM-positive and negative CRCs. After qRT-PCR validation, 11 miRNAs were consistently significant in the combined classifier construction set. Among them, miR-342-3p was the most significant one (P=4.3×10-4). Through logistic regression analysis, we developed a three-miRNA classifier (miR-342-3p, miR-361-3p, and miR-3621) for predicting LNM in T1-stage CRCs, yielding the area under the curve of 0.947 (94% sensitivity, 85% specificity and 89% accuracy). The discriminative ability of this system was consistently reliable in the independent validation set (83% sensitivity, 64% specificity and 70% of accuracy). Of the potential downstream targets of the three-miRNAs, expressions of E2F1, RAP2B, and AKT1 were significantly associated with LNM. In conclusion, this classifier can predict LNM more accurately than conventional pathologic criteria and our study results may be helpful to avoid unnecessary bowel surgery after endoscopic resection in early CRC.

Laparoscopic Surgery for Transverse Colon Cancer: Short- and Long-Term Outcomes in Comparison with Conventional Open Surgery.

BACKGROUND: Published studies on laparoscopic surgery for transverse colon cancer are scarce. More studies are necessary to evaluate the feasibility, safety, and long-term oncologic outcomes of laparoscopic surgery for transverse colon cancer. SUBJECTS AND METHODS: From April 1996 to December 2010, 102 consecutive patients with stage II or III disease who had undergone curative resection for transverse colon cancer were enrolled. Seventy-nine patients underwent laparoscopy-assisted colectomy (LAC), whereas 23 patients underwent conventional open colectomy (OC). Short- and long-term outcomes of the two groups were compared. RESULTS: The OC group had a larger tumor size (7.6 ± 3.4 cm versus 5.2 ± 2.3 cm, P = .004) and more retrieved lymph nodes (26.4 ± 11.6 versus 17.5 ± 9.4, P = .002), without differences in resection margins. In the LAC group, return to diet was faster (4.5 ± 1.2 days versus 5.4 ± 1.8 days, P = .013), and postoperative hospital stay was shorter (12.1 ± 4.2 days versus 15.9 ± 4.8 days, P = .000). There were no differences in occurrence of intra- or postoperative complications. There were no statistically significant differences in overall survival rate (OS) or disease-free survival rate (DFS) between the two groups (5-year OS, 90.4% versus 90.5%, P = .670; 5-year DFS, 84.2% versus 90.7%, P = .463). CONCLUSIONS: Laparoscopic surgery for transverse colon cancer has better short-term outcomes compared with open surgery, with acceptable long-term outcomes. As in colorectal cancer of other sites, laparoscopic surgery can be a feasible alternative to conventional surgery for transverse colon cancer.

Comparative study between transanal tube and loop ileostomy in low anterior resection for mid rectal cancer: a retrospective single center trial.

PURPOSE: To investigate the efficacy and safety of the transanal tube (TAT) in preventing anastomotic leak (AL) in rectal cancer surgery. METHODS: Clinical data of the patients who underwent curative surgery for mid rectal cancer from February 2010 to February 2014 were reviewed retrospectively. Rectal cancers arising 5 to 10 cm above the anal verge were selected. Patients were divided into the ileostomy, TAT, or no-protection groups. Postoperative complications including AL and postoperative course were compared. RESULTS: We included 137 patients: 67, 35, and 35 patients were included in the ileostomy, TAT, and no-protection groups, respectively. Operation time was longer in the ileostomy group (P = 0.029), and more estimated blood loss was observed (P = 0.018). AL occurred in 5 patients (7.5%) in the ileostomy group, 1 patients (2.9%) in the TAT group, and 6 patients (17.1%) in the no-protection group (P = 0.125). Patients in the ileostomy group resumed diet more than 1 day earlier than those in the other groups (P = 0.000). Patients in the no-protection group had about 1 or 2 days longer postoperative hospital stay (P = 0.048). The ileostomy group showed higher late complication rates than the other groups as complications associated with the stoma itself or repair operation developed (P = 0.019). CONCLUSION: For mid rectal cancer surgery, the TAT supports anastomotic site protection and diverts ileostomy-related complications. Further large scale randomized controlled studies are needed to gain more evidence and expand the range of TAT usage.

Niti CAR 27 Versus a Conventional End-to-End Anastomosis Stapler in a Laparoscopic Anterior Resection for Sigmoid Colon Cancer.

PURPOSE: The Niti CAR 27 (ColonRing) uses compression to create an anastomosis. This study aimed to investigate the safety and the effectiveness of the anastomosis created with the Niti CAR 27 in a laparoscopic anterior resection for sigmoid colon cancer. METHODS: In a single-center study, 157 consecutive patients who received an operation between March 2010 and December 2011 were retrospectively assessed. The Niti CAR 27 (CAR group, 63 patients) colorectal anastomoses were compared with the conventional double-stapled (CDS group, 94 patients) colorectal anastomoses. Intraoperative, immediate postoperative and 6-month follow-up data were recorded. RESULTS: There were no statistically significant differences between the two groups in terms of age, gender, tumor location and other clinical characteristics. One patient (1.6%) in the CAR group and 2 patients (2.1%) in the CDS group experienced complications of anastomotic leakage (P = 0.647). These three patients underwent a diverting loop ileostomy. There were 2 cases (2.1%) of bleeding at the anastomosis site in the CDS group. All patients underwent a follow-up colonoscopy (median, 6 months). One patient in the CAR group experienced anastomotic stricture (1.6% vs. 0%; P = 0.401). This complication was solved by using balloon dilatation. CONCLUSION: Anastomosis using the Niti CAR 27 device in a laparoscopic anterior resection for sigmoid colon cancer is safe and feasible. Its use is equivalent to that of the conventional double-stapler.

The nutritional risk is a independent factor for postoperative morbidity in surgery for colorectal cancer.

PURPOSE: The authors evaluate the prevalence of malnutrition and its effect on the postoperative morbidity of patients after surgery for colorectal cancer. METHODS: Three hundred fifty-two patients were enrolled prospectively. Nutritional risk screening 2002 (NRS 2002) score was calculated through interview with patient on admission. Clinical characteristics, tumor status and surgical procedure were recorded. RESULTS: The prevalence of patients at nutritional risk was 28.1 per cent according to the NRS 2002. The rate of postoperative complication was 27%. There was a significant difference in postoperative complication rates between patients at nutritional risk and those not at risk (37.4% vs. 22.9%, P = 0.006). Nutritional risk was identified as an independent predictor of postoperative complications (odds ratio, 3.05; P = 0.045). Nutritional risk increased the rate of anastomotic leakage (P = 0.027) and wound infection (P = 0.01). CONCLUSION: NRS may be a prognostic factor for postoperative complication after surgery for colorectal cancer. A large scaled prospective study is needed to confirm whether supplementing nutritional deficits reduces postoperative complication rates.

Single incision vs conventional laparoscopic anterior resection for sigmoid colon cancer: a case-matched study.

BACKGROUND: The purpose of the study was to evaluate the safety and effects of single-incision laparoscopic anterior resection (SILAR) for sigmoid colon cancer by comparing it with conventional laparoscopic anterior resection (CLAR). METHODS: Twenty-four patients who underwent SILAR between April 2010 and July 2011 were case matched 1:2 with patients who underwent CLAR, with respect to age, sex, body mass index, tumor location, and history of abdominal surgery. RESULTS: Two patients in the SILAR group and 1 patient in the CLAR group experienced anastomotic leakage. The operative time was longer in the SILAR group than in the CLAR group (251 ± 50 vs 237 ± 49 minutes; P = .253). The number of harvested lymph nodes (19.6 ± 10.7 vs 20.8 ± 7.7; P = .630) was not different. The postoperative hospital stay was shorter in the SILAR group (7.1 ± 3.4 days) than in the CLAR group (8.1 ± 3.5 days) (P = .234). CONCLUSIONS: On the basis of the early outcomes, we conclude that SILAR is feasible and safe. Moreover, the adequate lymph node harvest and free margins support the use of this procedure.

Initial experience of a surgical fellow in laparoscopic colorectal cancer surgery under training protocol and supervision: comparison of short-term results for 70 early cases (under supervision) and 73 late cases (without supervision).

PURPOSE: Laparoscopic colorectal surgery is a technically challenging procedure for beginners, such as surgical fellows. The purpose of this study was to assess the safety, feasibility, and short-term surgical outcomes of laparoscopic colorectal cancer surgery by a single surgical fellow. METHODS: The study analyzed the data from 143 consecutive patients who underwent laparoscopic colorectal resection by a single surgical fellow between August 2009 and October 2010. The patients were divided into two groups: the early group-the first 70 patients (under supervision of experienced surgeon), and the late group-the last 73 patients (without supervision). The short-term surgical results were compared between two groups. RESULTS: The operations were 24 right colon resections, two transverse colectomies, six left colectomies, 36 anterior resections, 57 low anterior resections, 12 intersphincteric resections, two abdominoperineal resections, three Hartmann's operations, and 1 total colectomy. The mean operating time, mean amounts of blood loss, and conversion rate were similar between the two groups. The morbidity rate, anastomosis leak rate, and mortality rate within 30 days of surgery did not differ significantly. The mean number of lymph nodes was larger in the late group (23.8 vs. 31.7, P = 0.017). In terms of low anterior resection, the mean number of endo-linear staplers used was smaller in the late group (2.46 ± 0.81 vs. 1.97 ± 0.83, P = 0.028). The anastomosis leakage rate in rectal cancer surgery was not significantly different between the two groups. CONCLUSIONS: This study demonstrates that laparoscopic colorectal resections can be independently performed safely after a period of supervision and training by an experienced surgeon.