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The PINS Trial: a prospective randomized clinical trial comparing a traditional versus an emollient skincare regimen for the care of pin-sites in patients with circular frames.
Ferguson, D, Harwood, P, Allgar, V, Roy, A, Foster, P, Taylor, M, Moulder, E, Sharma, H
The bone & joint journal. 2021;(2):279-285
Abstract
AIMS: Pin-site infection remains a significant problem for patients treated by external fixation. A randomized trial was undertaken to compare the weekly use of alcoholic chlorhexidine (CHX) for pin-site care with an emollient skin preparation in patients with a tibial fracture treated with a circular frame. METHODS Patients were randomized to use either 0.5% CHX or Dermol (DML) 500 emollient pin-site care. A skin biopsy was taken from the tibia during surgery to measure the dermal and epidermal thickness and capillary, macrophage, and T-cell counts per high-powered field. The pH and hydration of the skin were measured preoperatively, at follow-up, and if pin-site infection occurred. Pin-site infection was defined using a validated clinical system. RESULTS Out of 116 patients who were enrolled in the study, 23 patients (40%) in the CHX group and 26 (44%) in the DML group had at least one bad or ugly pin-site infection. This difference was not statistically significant (p = 0.71). There was no significant relationship between pH or hydration of the skin and pin-site infection. The epidermal thickness was found to be significantly greater in patients who had a pin-site infection compared with those who did not (p = 0.01). Skin irritation requiring a change of treatment occurred in four patients (7%) using CHX, and none using DML. CONCLUSION We found no significant difference in the incidence of pin-site infection between the CHX and DML treatment groups. Dermol appeared to offer a small but significant advantage in terms of tolerability. We did not find a significant association between patient or treatment related factors and pin-site infection. It is therefore difficult to make specific recommendations based upon these results. The use of either cleaning agent appears to be appropriate. Cite this article: Bone Joint J 2021;103-B(2):279-285.
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Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open-label, phase III study (NUTRILEAK study).
Gronnier, C, Chambrier, C, Duhamel, A, Dervaux, B, Collet, D, Vaudoyer, D, Régimbeau, JM, Jougon, J, Théréaux, J, Lebreton, G, et al
Trials. 2020;(1):448
Abstract
BACKGROUND Postoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and increased health costs. Nutritional support is a key component of therapy in such cases, which is related to the high prevalence of malnutrition. In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery. There is little evidence available for the curative setting after fistula occurrence. We hypothesize that EN increases the 30-day fistula closure rate in PUGIF, allowing better health-related quality of life without increasing the morbidity or mortality. METHODS/DESIGN The NUTRILEAK trial is a multicenter, randomized, parallel-group, open-label phase III trial to assess the efficacy of EN (the experimental group) compared with TPN (the control group) in patients with PUGIF. The primary objective of the study is to compare EN versus TPN in the treatment of PUGIF (after esophagogastric resection including bariatric surgery, duodenojejunal resection or pancreatic resection with digestive tract violation) in terms of the 30-day fistula closure rate. Secondary objectives are to evaluate the 6-month postrandomization fistula closure rate, time of first fistula closure (in days), the medical- and surgical treatment-related complication rate at 6 months after randomization, the fistula-related complication rate at 6 months after randomization, the type and severity of early (30 days after randomization) and late fistula-related complications (over 30 days after randomization), 30-day and 6-month postrandomization mortality rate, nutritional status at day 30, day 60, day 90 and day 180 postrandomization, the mean length of hospital stay, the patient's health-related quality of life (by self-assessment questionnaire), oral feeding time and direct costs of treatment. A total of 321 patients will be enrolled. DISCUSSION The two nutritional supports are already used in daily practice, but most surgeons are reluctant to use the enteral route in case of PUGIF. This study will be the first randomized trial testing the role of EN versus TPN in PUGIF. TRIAL REGISTRATION ClinicalTrials.gov: NCT03742752. Registered on 14 November 2018.
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Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial.
Carli, F, Bousquet-Dion, G, Awasthi, R, Elsherbini, N, Liberman, S, Boutros, M, Stein, B, Charlebois, P, Ghitulescu, G, Morin, N, et al
JAMA surgery. 2020;(3):233-242
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Abstract
IMPORTANCE Research supports use of prehabilitation to optimize physical status before and after colorectal cancer resection, but its effect on postoperative complications remains unclear. Frail patients are a target for prehabilitation interventions owing to increased risk for poor postoperative outcomes. OBJECTIVE To assess the extent to which a prehabilitation program affects 30-day postoperative complications in frail patients undergoing colorectal cancer resection compared with postoperative rehabilitation. DESIGN, SETTING, AND PARTICIPANTS This single-blind, parallel-arm, superiority randomized clinical trial recruited patients undergoing colorectal cancer resection from September 7, 2015, through June 19, 2019. Patients were followed up for 4 weeks before surgery and 4 weeks after surgery at 2 university-affiliated tertiary hospitals. A total of 418 patients 65 years or older were assessed for eligibility. Of these, 298 patients were excluded (not frail [n = 290], unable to exercise [n = 3], and planned neoadjuvant treatment [n = 5]), and 120 frail patients (Fried Frailty Index,≥2) were randomized. Ten patients were excluded after randomization because they refused surgery (n = 3), died before surgery (n = 3), had no cancer (n = 1), had surgery without bowel resection (n = 1), or were switched to palliative care (n = 2). Hence, 110 patients were included in the intention-to-treat analysis (55 in the prehabilitation [Prehab] and 55 in the rehabilitation [Rehab] groups). Data were analyzed from July 25 through August 21, 2019. INTERVENTIONS Multimodal program involving exercise, nutritional, and psychological interventions initiated before (Prehab group) or after (Rehab group) surgery. All patients were treated within a standardized enhanced recovery pathway. MAIN OUTCOMES AND MEASURES The primary outcome included the Comprehensive Complications Index measured at 30 days after surgery. Secondary outcomes were 30-day overall and severe complications, primary and total length of hospital stay, 30-day emergency department visits and hospital readmissions, recovery of walking capacity, and patient-reported outcome measures. RESULTS Of 110 patients randomized, mean (SD) age was 78 (7) years; 52 (47.3%) were men and 58 (52.7%) were women; 31 (28.2%) had rectal cancer; and 87 (79.1%) underwent minimally invasive surgery. There was no between-group difference in the primary outcome measure, 30-day Comprehensive Complications Index (adjusted mean difference, -3.2; 95% CI, -11.8 to 5.3; P = .45). Secondary outcome measures were also not different between groups. CONCLUSIONS AND RELEVANCE In frail patients undergoing colorectal cancer resection (predominantly minimally invasive) within an enhanced recovery pathway, a multimodal prehabilitation program did not affect postoperative outcomes. Alternative strategies should be considered to optimize treatment of frail patients preoperatively. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02502760.
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Early oral feeding versus traditional feeding after transanal endorectal pull-through procedure in Hirschsprung's disease.
Ashjaei, B, Ghamari Khameneh, A, Darban Hosseini Amirkhiz, G, Nazeri, N
Medicine. 2019;(10):e14829
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Our study questioned whether the outcome of postoperative early oral feeding is different from traditional postoperative feeding in children with Hirschsprung's disease who underwent transanal endorectal pull-through.This was an observational and comparative study. Patients were allocated into 2 groups. Age, gender, fever, surgery-related infectious, abdominal distension, bowel obstruction, need for reoperation, peritonitis, anastomosis leak, and abscess formation were assessed. IV fluids and antibiotics usage were recorded. A Chi-square test, independent sample unpaired Student t test and Mann-Whitney test were used. P-value < .05 was considered statistically significant.Infections occurred in no patient in group 1 and 1 patient in group 2. Stenosis occurred in 3 patients in group 1 and 2 patients in group 2. Abdominal distension occurred in 4 patients in group 1 and 3 patients in group 2. Fever occurred in 2 patients in group 1 and 1 patient in group 2 within the first 24 hours and it occurred in 13 and 17 patients, respectively, within 48 hours. All patients of group 1 (n = 15) were treated with antibiotics and intravenous fluid administration; 1 patient for 24 hours, 12 patients for 48 hours, and 1 for 72 hours, respectively. All patients of group 2 (n = 18) were treated with antibiotics and intravenous fluid administration for 5 days. We noted a significant difference regarding the duration of antibiotic treatment and intravenous fluid administration after 72 hours.This study showed that there was no difference between the outcomes of early and traditional postoperative feeding. Due to a significant difference in the antibiotics and IV fluid administration intervals between these 2 groups which cause a prolonged hospital stay and higher costs, it seems that early postoperative feeding is superior to traditional strategy.
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Does Postoperative Rehabilitation for Radical Cystectomy Call for Enhanced Recovery after Surgery? A Systematic Review and Meta-analysis.
Xiao, J, Wang, M, He, W, Wang, J, Yang, F, Ma, XY, Zang, Y, Yang, CG, Yu, G, Wang, ZH, et al
Current medical science. 2019;(1):99-110
Abstract
The aim of this review was to systematically compare the outcomes of enhanced recovery after surgery (ERAS) with standard care (SC) after radical cystectomy. We performed a systematic search of PubMed, Ovid, Web of Science, and the Cochrane Library to identify studies published until September 2017 which involved a comparison of ERAS and SC. A meta-analysis was performed to assess the outcomes of ERAS versus SC. Sixteen studies including 8 prospective and 8 retrospective trials met the eligibility criteria. A total of 2100 participants were assigned to ERAS (1258 cases) or SC (842 cases). The time to first flatus passage {WMD=-0.95 days, 95% CI (-1.50,-0.41), P=0.0006}, time until return to a regular diet {WMD=-2.15 days, 95% CI (-2.86,-1.45), P<0.00001} and the length of hospital stay {WMD=-3.75 days, 95% CI (-5.13,-2.36), P<0.00001} were significantly shorter, and the incidence of postoperative complications {OR=0.60, 95% CI (0.44, 0.83), P=0.002}, especially postoperative paralytic ileus {OR=0.43, 95% CI (0.30, 0.62), P<0.00001} and cardiovascular complications {OR=0.28, 95% CI (0.09, 0.90), P=0.03} was significantly lower in the ERAS group than those in the SC group. This meta-analysis demonstrated that ERAS was associated with a shorter time to first flatus passage, return of bowel function, and the length of hospital stay than SC in patients undergoing radical cystectomy, as well as a lower rate of postoperative complications, especially paralytic ileus and cardiovascular complications.
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[Early versus traditional postoperative oral feeding in patients undergoing elective colorectal surgery: a meta-analysis of safety and efficacy].
Zhang, K, Cheng, S, Zhu, Q, Han, Z
Zhonghua wei chang wai ke za zhi = Chinese journal of gastrointestinal surgery. 2017;(9):1060-1066
Abstract
OBJECTIVE To compare the outcomes of early oral feeding (EOF) and the traditional oral feeding (TOF) in postoperative patients with colorectal cancer using Meta-analysis. METHODS The databases of PubMed, SCI, Ovid, The Cochrane Library, CNKI, CBM, VIP and Wanfang Data were searched to collect randomized controlled trial (RCT) about EOF versus TOF in patients undergoing elective colorectal surgery. The retrieval time span was from inception to June 1, 2016. The studies were screened according to the inclusion and exclusion criteria. The data were extracted and the quality was evaluated by 2 reviewers independently. The Meta-analysis was conducted using RevMan 5.2 software. RESULTS A total of 14 studies with 1 807 patients (906 cases in EOF group and 901 cases in TOF group) were included. The time to first passage of flatus (MD=-16.11 h, 95%CI:-18.27 to -13.94 h, P=0.00), postoperative hospital stay (MD=-1.92 d, 95%CI:-2.83 to -1.01 d, P=0.00), hospitalization cost (ten thousand yuan) (MD=-0.58, 95%CI:-0.71 to -0.46, P=0.00) were less in EOF group compared to TOF group. EOF patients had lower total complication rate (OR=0.68, 95%CI:0.48 to 0.95, P=0.03), in which the pulmonary infection (OR=0.27, 95%CI:0.13 to 0.53, P=0.00), pharyngolaryngitis (OR=0.06, 95%CI:0.04 to 0.11, P=0.00) were lower than those in TOF group, while the tube reinsertion (OR=2.34, 95%CI:1.08 to 5.07, P=0.03) was higher. The incidence of anastomotic leakage, nausea, vomiting, abdominal distension, diarrhea, and wound infection between two groups was not significantly different(all P>0.05). There was no significant difference between two groups in IgM (P>0.05), while the IgA (MD=0.3, 95%CI:0.12 to 0.48, P=0.00), IgG (MD=2.13 ,95%CI:0.82 to 3.44, P=0.001), CD4+ (MD=3.80, 95%CI:2.55 to 5.04, P=0.00), CD4+/CD8+ (MD=0.22, 95%CI:0.04 to 0.41, P=0.02) in EOF group were higher than those in TOF group. Postoperative CRP decreased rapidly in EOF group (MD=-30.10, 95%CI:-48.07 to -12.13, P=0.00), and IL-6 was not significantly different (P>0.05). EOF patients had higher serum albumin level 5 days after operation (MD=3.27, 95%CI: 2.48 to 4.07, P=0.00). CONCLUSIONS EOF can promote gas passage and defecation, reduce postoperative hospital stay and treatment costs. Also, it can decrease the incidence of complications and postoperative inflammation, and maintain immune function.
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Nasoenteric tube versus jejunostomy for enteral nutrition feeding following major upper gastrointestinal operations: a meta-analysis.
Wang, L, Tian, Z, Liu, Y
Asia Pacific journal of clinical nutrition. 2017;(1):20-26
Abstract
BACKGROUND AND OBJECTIVES Following major upper gastrointestinal surgical procedures, early enteral nutrition to the jejunum is strongly recommended, either through a nasoenteric tube or a percutaneous transperitoneal jejunal feeding tube (jejunostomy). However, to date there has been no consensus as to the best enteral feeding strategy. Our aim was to determine the safest and most efficacious early enteral nutrition supplement strategy following major upper gastrointestinal operations. METHODS AND STUDY DESIGN PubMed, Embase and Cochrane Library databases were systematically searched for comparison of trials. The primary outcome analyzed was length of postoperative hospital stay, and secondary outcomes were: duration of enteral nutrition, time to resumption of normal oral intake, and tube dislodgement, tube leakage and tube obstruction complications. Weighted mean differences (WMDs) and risk ratios (RRs) were calculated with 95% confidence intervals (CI). RESULTS A total of 5 studies were included with 420 patients in all. The length of hospital stay, duration of enteral nutrition and the time to resumption of normal oral intake were all significantly shorter in the nasoenteric group (p<0.05). There was no increase or reduction in the RR of tube obstruction between the nasoenteric and jejunostomy groups (p=0.5). The RR of tube dislodgement was increased in the nasoenteric group (p<0.05) while the RR of tube leakage was increased in the jejunostomy group (p<0.05). CONCLUSIONS A nasoenteric tube is more likely to be effective in early postoperative enteral feeding following major upper gastrointestinal operations.
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Beneficial Effects of Early Enteral Nutrition After Major Rectal Surgery: A Possible Role for Conditionally Essential Amino Acids? Results of a Randomized Clinical Trial.
van Barneveld, KW, Smeets, BJ, Heesakkers, FF, Bosmans, JW, Luyer, MD, Wasowicz, D, Bakker, JA, Roos, AN, Rutten, HJ, Bouvy, ND, et al
Critical care medicine. 2016;(6):e353-61
Abstract
OBJECTIVES To investigate direct postoperative outcome and plasma amino acid concentrations in a study comparing early enteral nutrition versus early parenteral nutrition after major rectal surgery. Previously, it was shown that a low plasma glutamine concentration represents poor prognosis in ICU patients. DESIGN A preplanned substudy of a previous prospective, randomized, open-label, single-centre study, comparing early enteral nutrition versus early parenteral nutrition in patients at high risk of postoperative ileus after surgery for locally advanced or locally recurrent rectal cancer. Early enteral nutrition reduced postoperative ileus, anastomotic leakage, and hospital stay. SETTING Tertiary referral centre for locally advanced and recurrent rectal cancer. PATIENTS A total of 123 patients with locally advanced or recurrent rectal carcinoma requiring major rectal surgery. INTERVENTIONS Patients were randomized (ALEA web-based external randomization) preoperatively into two groups: early enteral nutrition (early enteral nutrition, intervention) by nasojejunal tube (n = 61) or early parenteral nutrition (early parenteral nutrition, control) by jugular vein catheter (n = 62). Eight hours after the surgical procedure artificial nutrition was started in hemodynamically stable patients, stimulating oral intake in both groups. Blood samples were collected to measure plasma glutamine, citrulline, and arginine concentrations using a validated ultra performance liquid chromatography-tandem mass spectrometric method. MEASUREMENTS AND MAIN RESULTS Baseline concentrations were comparable for both groups. Directly after rectal surgery, a decrease in plasma amino acids was observed. Plasma glutamine concentrations were higher in the parenteral group than in the enteral group on postoperative day 1 (p = 0.027) and day 5 (p = 0.008). Arginine concentrations were also significantly increased in the parenteral group at day 1 (p < 0.001) and day 5 (p = 0.001). CONCLUSIONS Lower plasma glutamine and arginine concentrations were measured in the enteral group, whereas a better clinical outcome was observed. We conclude that plasma amino acids do not provide a causal explanation for the observed beneficial effects of early enteral feeding after major rectal surgery.
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A comparison of preemptive versus standard renal replacement therapy for acute kidney injury after cardiac surgery.
Yang, XM, Tu, GW, Gao, J, Wang, CS, Zhu, DM, Shen, B, Liu, L, Luo, Z
The Journal of surgical research. 2016;(1):205-12
Abstract
BACKGROUND The optimal timing of renal replacement therapy (RRT) initiation in patients undergoing cardiac surgery remains controversial. This study aimed to determine whether preemptive RRT or standard RRT was associated with hospital mortality in cardiac surgical patients with acute kidney injury (AKI). METHODS Data were retrospectively collected from patients who underwent cardiac surgery and experienced postoperative AKI requiring RRT at Zhongshan Hospital of Fudan University from September 1, 2006 to December 31, 2013. The patients were divided into two groups according to the RRT strategy applied. RESULTS A total of 213 patients were enrolled in this study; 59 patients were categorized into the preemptive RRT group and 154 into the standard RRT group. The preemptive RRT group exhibited significantly lower mortality (33.90% versus 51.95%, P = 0.018) and time to recovery of renal function than the standard RRT group (15.34 ± 14.46 versus 22.88 ± 14.08 d, P = 0.022). Moreover, the preemptive RRT group showed significantly lower serum creatinine levels and higher proportions of recovery of renal function and weaning from RRT at death or discharge than the standard RRT group. There was no significant difference in the duration of mechanical ventilation, RRT, intensive care unit stay, or hospital stay between the two groups. CONCLUSIONS In patients after cardiac surgery, preemptive RRT was associated with lower hospital mortality and faster and more frequent recovery of renal function than standard RRT. However, preemptive RRT did not affect other patient-centered outcomes including mechanical ventilation time, RRT time, or length of intensive care unit or hospital stay.
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Safety of a new protocol decreasing antibiotic utilization after laparoscopic appendectomy for perforated appendicitis in children: A prospective observational study.
Desai, AA, Alemayehu, H, Holcomb, GW, St Peter, SD
Journal of pediatric surgery. 2015;(6):912-4
Abstract
INTRODUCTION In a previous randomized trial, we found children with perforated appendicitis could be safely discharged prior to completion of a 5 day intravenous antibiotics course. To progress the protocol further, patients who met discharge criteria early were discharged without oral antibiotics if leukocyte counts were normal. METHODS Children undergoing laparoscopic appendectomy for perforated appendicitis were prospectively observed after institution of a new antibiotic regimen consisting of daily intravenous dosing ceftriaxone/metronidazole while an inpatient. Patients discharged prior to 5 days were discharged home without oral amoxicillin-clavulanate if no leukocytosis at discharge. Outcomes were compared to the previous protocol of daily intravenous ceftriaxone/metronidazole with completion of a 7-day antibiotic course with amoxicillin-clavulanate of all patients discharged prior to 5 days. RESULTS 540 patients (270 new protocol, 270 old protocol) were identified. There was no significant difference in patient demographics, admission leukocyte count, time to regular diet, or length of stay. Postoperative abscess occurred in 21.8% in the new protocol compared to 19.3% of the previous (P=0.5). There was a significant decrease in the number of patients discharged home on oral antibiotic therapy (P<0.001). CONCLUSIONS Patients meeting discharge criteria with normal leukocyte count prior to completion of 5 days IV antibiotic therapy can be safely discharged home without oral antibiotics after laparoscopic appendectomy for perforated appendicitis.