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The effects of 0.9% saline versus Plasma-Lyte 148 on renal function as assessed by creatinine concentration in patients undergoing major surgery: A single-centre double-blinded cluster crossover trial.
Weinberg, L, Li, MH, Churilov, L, Macgregor, C, Garrett, K, Eyles, J, Bellomo, R
PloS one. 2021;(5):e0251718
Abstract
OBJECTIVES Saline and Plasma-Lyte have different physiochemical contents; consequently, they may differently affect patients' renal function. We compared the effects of fluid therapy with 0.9% saline and with Plasma-Lyte 148 on renal function as assessed by creatinine concentration among patients undergoing major surgery. METHODS We conducted a prospective, double-blinded cluster crossover trial comparing the effects of the two fluids on major surgery patients. The primary aim was to establish the pilot feasibility, safety and preliminary efficacy evidence base for a large interventional trial to establish whether saline or Plasma-Lyte is the preferred crystalloid fluid for managing major surgery patients. The primary efficacy outcome was the proportion of patients with changes in renal function as assessed by creatinine concentration during their index hospital admission. We used changes in creatinine to define acute kidney injury (AKI) according to the RIFLE criteria. RESULTS The study was feasible with 100% patient and clinician acceptance. There were no deviations from the trial protocol. After screening, we allocated 602 patients to saline and 458 to Plasma-Lyte. The median (IQR) volume of intraoperative fluid received was 2000 mL (1000:2000) in both groups. Forty-nine saline patients (8.1%) and 49 Plasma-Lyte patients (10.7%) developed a postoperative AKI (adjusted incidence rate ratio [aIRR]: 1.34; 95% CI: 0.93-1.95; p = 0.120). No differences were observed in the development of postoperative complications (aIRR: 0.98; 95% CI: 0.89-1.08) or the severity of the worst complication (aIRR: 1.00; 95% CI: 0.78-1.30). The median (IQR) length of hospital stay was six days (3:11) for the saline group and five days (3:10) for the Plasma-Lyte group (aIRR: 0.85; 95% CI: 0.73-0.98). There were no serious adverse events relating to the trial fluids, nor were there fluid crossover or contamination events. CONCLUSIONS The study design was feasible to support a future follow-up larger clinical trial. Patients treated with saline did not demonstrate an increased incidence of postoperative AKI (defined as changes in creatinine) compared to those treated with Plasma-Lyte. Our findings imply that clinicians can reasonably use either solution intraoperatively for adult patients undergoing major surgery. TRIAL REGISTRATION Registry: Australian New Zealand Clinical Trials Registry; ACTRN12613001042730; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364988.
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Squeaking Is Common and Increases Over Time Among Patients With Long-term Follow-up After Ceramic-on-ceramic THA.
Taniguchi, K, Quacinella, M, Barlow, B
Clinical orthopaedics and related research. 2021;(4):736-744
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BACKGROUND Ceramic-on-ceramic (CoC) is a durable bearing with excellent wear characteristics, but squeaking remains a concern. The proportion of patients who report squeaking varies widely between studies performed at short- and mid-term follow-up. QUESTIONS/PURPOSES (1) What proportion of patients treated with CoC THA bearings report squeaking at a minimum of 10 years of follow-up? (2) Are patient, implant, or radiographic factors associated with squeaking? (3) Are THAs that squeak more likely to be revised than those that do not? (4) Are patient-reported functional outcome scores lower between THAs that squeak and THAs that do not squeak at long-term follow-up? METHODS Between January 1, 2003 and August 31, 2008 a total of 80 patients received THAs with third-generation alumina-on-alumina bearings at one center. Of the original 80 patients, 1% (1 of 80) had died, and 21% (17 of 80) were lost to follow-up before 10 years, leaving 62 patients for analysis at a median (range) of 14 years (11 to 16). Ceramic-on-ceramic THA represented 23% (80 of 343) of all primary THAs performed during the study period. Ceramic-on-ceramic THA was used preferentially in patients younger than 50 years of age. The mean (range) age of patients in the cohort was 44 ± 11 years (18 to 65). Sixty-eight percent (42 of 62) were men. Two separate manufacturers' implants were included. There were uncemented acetabular and femoral components included in this study. All CoC bearings were third-generation alumina-on-alumina. Squeaking was determined through a mailed questionnaire or telephone interview. The 10-question survey developed by the researchers queried patients whether audible "squeaking" could be heard from their hip replacement. Patients were asked to write in their description of the noise to distinguish squeaking from other noises not relevant to the current study. Implant information, component position, and patient demographics were obtained via chart review and postoperative radiographs reviewed by one of the investigators not involved with the index operative procedure. Using revision for any reason as an endpoint, a Kaplan-Meier analysis was performed to compare survivorship between THAs that squeaked versus those that did not. Patient-reported outcomes were surveyed using the Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR), which comprises six items regarding patient pain and function, raw summed scores range from 0 (perfect hip health) to 24 (total hip disability). RESULTS Squeaking was self-reported by 53% (33 of 62) of patients in this group. Squeaking was more common in patients who received the titanium-molybdenum-zirconium-iron stem than in patients with the titanium-aluminum-vanadium stem (63% [29 of 46] versus 31% [4 of 13]; odds ratio 3.8 [95% CI 1.02 to 14.4]; p = 0.046). We found no differences in the likelihood a patient would report squeaking based on component position, component size, patient age, sex, or BMI. Ten-year survivorship free from revision was not lower in patients who reported squeaking (91% [95% CI 74 to 97] versus 90% [95% CI 71 to 96]; p = 0.69). Patient-reported outcome scores (HOOS JR) were not lower in those who reported squeaking (3 ± 3 [95% CI 1.5 to 4.0] versus 3 ± 5 [95% CI 1.5 to 5.5]; p = 0.59). CONCLUSION At long-term follow-up, we found that CoC bearing squeaking in patients who underwent THA is more common than previously reported. Survivorship was lower than expected in this cohort, and most revisions in this series were for squeaking. Although implant-dependent, surgeons should counsel patients about the potential for squeaking in CoC THA, which may occur years after index procedure. LEVEL OF EVIDENCE Level III, therapeutic study.
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Short-term Outcomes of Single-port Versus Multiport Laparoscopic Surgery for Colon Cancer: The SIMPLE Multicenter Randomized Clinical Trial.
Lee, YS, Kim, JH, Kim, HJ, Lee, SC, Kang, BM, Kim, CW, Lim, SW, Lee, SH, Kim, JG
Annals of surgery. 2021;(2):217-223
Abstract
OBJECTIVE To compare short-term perioperative outcomes of single-port laparoscopic surgery (SPLS) and multiport laparoscopic surgery (MPLS) for colon cancer. SUMMARY BACKGROUND DATA Although many studies reported short- and long-term outcomes of SPLS for colon cancer compared with MPLS, few have reported results of randomized controlled trials. METHODS This was a multicenter, prospective, randomized controlled trial with a noninferiority design. It was conducted between August 2011 and June 2017 at 7 sites in Korea. A total of 388 adults (aged 19-85 yrs) with clinical stage I, II, or III adenocarcinoma of the ascending or sigmoid colon were enrolled and randomized. The primary endpoint was 30-day postoperative complication rates. Secondary endpoints were the number of harvested lymph nodes, length of the resection margin, postoperative pain, and time to functional recovery (bowel movement and diet). Patients were followed for 30 days after surgery. RESULTS Among 388 patients, 359 (92.5%) completed the study (SPLS, n = 179; MPLS, n = 180). The 30-day postoperative complication rate was 10.6% in the SPLS group and 13.9% in the MPLS group (95% confidence interval, -10.05 to 3.05 percentage points; P < 0.0001). Total incision length was shorter in the SPLS group than in the MPLS group (4.6 cm vs 7.2 cm, P < 0.001), whereas the length of the specimen extraction site did not differ (4.4 cm vs 4.6 cm, P = 0.249). There were no significant differences between groups for all secondary endpoints and all other outcomes. CONCLUSIONS Even though there was no obvious benefit to SPLS over MPLS when performing colectomy for cancer, our data suggest that SPLS is noninferior to MPLS and can be considered an option in selected patients, when performed by experienced surgeons.Trial registration: ClinicalTrials.gov Identifier: NCT01480128.
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Hemodynamic, renal and hormonal effects of lung protective ventilation during robot-assisted radical prostatectomy, analysis of secondary outcomes from a randomized controlled trial.
Høyer, S, Mose, FH, Ekeløf, P, Jensen, JB, Bech, JN
BMC anesthesiology. 2021;(1):200
Abstract
BACKGROUND Lung protective ventilation with low tidal volume (TV) and increased positive end-expiratory pressure (PEEP) can have unfavorable effects on the cardiovascular system. We aimed to investigate whether lung protective ventilation has adverse impact on hemodynamic, renal and hormonal variables. METHODS In this randomized, single-blinded, placebo-controlled study, 24 patients scheduled for robot-assisted radical prostatectomy were included. Patients were equally randomized to receive either ventilation with a TV of 6 ml/IBW and PEEP of 10 cm H2O (LTV-h.PEEP) or ventilation with a TV of 10 ml/IBW and PEEP of 4 cm H2O (HTV-l.PEEP). Before, during and after surgery, hemodynamic variables were measured, and blood and urine samples were collected. Blood samples were analyzed for plasma concentrations of electrolytes and vasoactive hormones. Urine samples were analyzed for excretions of electrolytes and markers of nephrotoxicity. RESULTS Comparable variables were found among the two groups, except for significantly higher postoperative levels of plasma brain natriuretic peptide (p = 0.033), albumin excretion (p = 0.012) and excretion of epithelial sodium channel (p = 0.045) in the LTV-h.PEEP ventilation group compared to the HTV-l.PEEP ventilation group. In the combined cohort, we found a significant decrease in creatinine clearance (112.0 [83.4;126.7] ml/min at baseline vs. 45.1 [25.4;84.3] ml/min during surgery) and a significant increase in plasma concentrations of renin, angiotensin II, and aldosterone. CONCLUSION Lung protective ventilation was associated with minor adverse hemodynamic and renal effects postoperatively. All patients showed a substantial but transient reduction in renal function accompanied by activation of the renin-angiotensin-aldosterone system. TRIAL REGISTRATION ClinicalTrials, NCT02551341 . Registered 13 September 2015.
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A prospective randomized controlled trial comparing the systemic inflammatory response in conventional jig-based total knee arthroplasty versus robotic-arm assisted total knee arthroplasty.
Kayani, B, Tahmassebi, J, Ayuob, A, Konan, S, Oussedik, S, Haddad, FS
The bone & joint journal. 2021;(1):113-122
Abstract
AIMS: The primary aim of this study was to compare the postoperative systemic inflammatory response in conventional jig-based total knee arthroplasty (conventional TKA) versus robotic-arm assisted total knee arthroplasty (robotic TKA). Secondary aims were to compare the macroscopic soft tissue injury, femoral and tibial bone trauma, localized thermal response, and the accuracy of component positioning between the two treatment groups. METHODS This prospective randomized controlled trial included 30 patients with osteoarthritis of the knee undergoing conventional TKA versus robotic TKA. Predefined serum markers of inflammation and localized knee temperature were collected preoperatively and postoperatively at six hours, day 1, day 2, day 7, and day 28 following TKA. Blinded observers used the Macroscopic Soft Tissue Injury (MASTI) classification system to grade intraoperative periarticular soft tissue injury and bone trauma. Plain radiographs were used to assess the accuracy of achieving the planned postioning of the components in both groups. RESULTS Patients undergoing conventional TKA and robotic TKA had comparable changes in the postoperative systemic inflammatory and localized thermal response at six hours, day 1, day 2, and day 28 after surgery. Robotic TKA had significantly reduced levels of interleukin-6 (p < 0.001), tumour necrosis factor-α (p = 0.021), ESR (p = 0.001), CRP (p = 0.004), lactate dehydrogenase (p = 0.007), and creatine kinase (p = 0.004) at day 7 after surgery compared with conventional TKA. Robotic TKA was associated with significantly improved preservation of the periarticular soft tissue envelope (p < 0.001), and reduced femoral (p = 0.012) and tibial (p = 0.023) bone trauma compared with conventional TKA. Robotic TKA significantly improved the accuracy of achieving the planned limb alignment (p < 0.001), femoral component positioning (p < 0.001), and tibial component positioning (p < 0.001) compared with conventional TKA. CONCLUSION Robotic TKA was associated with a transient reduction in the early (day 7) postoperative inflammatory response but there was no difference in the immediate (< 48 hours) or late (day 28) postoperative systemic inflammatory response compared with conventional TKA. Robotic TKA was associated with decreased iatrogenic periarticular soft tissue injury, reduced femoral and tibial bone trauma, and improved accuracy of component positioning compared with conventional TKA. Cite this article: Bone Joint J 2021;103-B(1):113-122.
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Goal-directed fluid therapy in emergency abdominal surgery: a randomised multicentre trial.
Aaen, AA, Voldby, AW, Storm, N, Kildsig, J, Hansen, EG, Zimmermann-Nielsen, E, Jensen, KM, Tibæk, P, Mortensen, A, Møller, AM, et al
British journal of anaesthesia. 2021;(4):521-531
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BACKGROUND More than 50% of patients have a major complication after emergency gastrointestinal surgery. Intravenous (i.v.) fluid therapy is a life-saving part of treatment, but evidence to guide what i.v. fluid strategy results in the best outcome is lacking. We hypothesised that goal-directed fluid therapy during surgery (GDT group) reduces the risk of major complications or death in patients undergoing major emergency gastrointestinal surgery compared with standard i.v. fluid therapy (STD group). METHODS In a randomised, assessor-blinded, two-arm, multicentre trial, we included 312 adult patients with gastrointestinal obstruction or perforation. Patients in the GDT group received i.v. fluid to near-maximal stroke volume. Patients in the STD group received i.v. fluid following best clinical practice. Postoperative target was 0-2 L fluid balance. The primary outcome was a composite of major complications or death within 90 days. Secondary outcomes were time in intensive care, time on ventilator, time in dialysis, hospital stay, and minor complications. RESULTS In a modified intention-to-treat analysis, we found no difference in the primary outcome between groups: 45 (30%) (GDT group) vs 39 (25%) (STD group) (odds ratio=1.24; 95% confidence interval, 0.75-2.05; P=0.40). Hospital stay was longer in the GDT group: median (inter-quartile range), 7 (4-12) vs 6 days (4-8.5) (P=0.04); no other differences were found. CONCLUSION Compared with pressure-guided i.v. fluid therapy (STD group), flow-guided fluid therapy to near-maximal stroke volume (GDT group) did not improve the outcome after surgery for bowel obstruction or gastrointestinal perforation but may have prolonged hospital stay. CLINICAL TRIAL REGISTRATION EudraCT number 2015-000563-14; the Danish Scientific Ethics Committee and the Danish Data Protection Agency (REG-18-2015).
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Combined epidural-general anaesthesia vs general anaesthesia in neonatal gastrointestinal surgery: A randomized controlled trial.
Gannam-Somri, L, Matter, I, Hadjittofi, C, Vaida, S, Khalaily, H, Hossein, J, Somri, M
Acta anaesthesiologica Scandinavica. 2020;(1):34-40
Abstract
BACKGROUND Post-operative ileus is a frequent complication of gastrointestinal surgery under general anaesthesia. The aim of this study was to investigate whether combined epidural-general anaesthesia is associated with expedited gastrointestinal function recovery in neonates undergoing elective gastrointestinal surgery. METHODS A randomized controlled trial including 60 neonates who underwent gastrointestinal surgery at a university hospital was performed. Thirty neonates received combined epidural-general anaesthesia (CEGA), and 30 neonates received general anaesthesia (GA) alone. The primary outcome was the post-operative time to tolerance of full enteral nutrition. The secondary outcomes were the post-operative time defaecation, the duration of nasogastric drainage, and infections. RESULTS After excluding two neonates from the CEGA group, where repeated attempts at epidural catheterization were unsuccessful, a total of 58 patients completed the study (CEGA: 28; GA: 30). Full enteral nutrition was tolerated earlier in CEGA vs the GA group (4.0 vs 8.0 days; P = .0001). Time to defaecation was shorter in the CEGA group (3.5 vs 5.0 days; P = .0001). Duration of nasogastric drainage was similar between groups (7.0 vs 7.0 days; P = .9502). Fewer patients in the CEGA group experienced post-operative infection (35.7% vs 60.0%; P = .038). CONCLUSION Combined epidural-general anaesthesia is associated with expedited gastrointestinal function recovery and a lower infection risk after gastrointestinal surgery in neonates.
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Laparoscopic versus open distal gastrectomy for advanced gastric cancer: A meta-analysis of randomized controlled trials and high-quality nonrandomized comparative studies.
Chen, X, Feng, X, Wang, M, Yao, X
European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology. 2020;(11):1998-2010
Abstract
BACKGROUND Controversy persists about the effects of laparoscopic distal gastrectomy (LDG) versus open distal gastrectomy (ODG) on short-term surgical outcomes and long-term survival within the field of advanced gastric cancer (AGC). METHODS Studies published from January 1994 to February 2020 that compare LDG and ODG for AGC were identified. All randomized controlled trials (RCTs) were included. The selection of high-quality nonrandomized comparative studies (NRCTs) was based on a validated tool (Methodological Index for Nonrandomized Studies, MINORS). The short- and long-term outcomes of both procedures were compared. RESULTS Overall, 30 studies were included in this meta-analysis, which comprised of 8 RCTs and 22 NRCTs involving 16,029 patients (7864 LDGs, 8165 ODGs). The recurrence, 3-year disease-free survival (DFS), 3-year overall survival (OS), and 5-year OS rates for LDG and ODG were comparable. LDG was associated with a lower postoperative complication rate (OR 0.79; P < 0.00001), lower estimated volume of blood loss (WMD -102.21 mL; P < 0.00001), shorter postoperative hospital stay (WMD -1.96 days; P < 0.0001), shorter time to first flatus (WMD -0.54 day; P = 0.0007) and shorter time to first liquid diet (WMD -0.66 day; P = 0.001). The number of lymph nodes retrieved, mortality, intraoperative complications, intraoperative blood transfusion, and time to ambulation were similar. However, LDG was associated with a longer surgical time (WMD 33.57 min; P < 0.00001). CONCLUSIONS LDG with D2 lymphadenectomy is a safe and effective technique for patients with AGC when performed by experienced surgeons at high-volume specialized centers.
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Comparative risk of fracture for bariatric procedures in patients with obesity: A systematic review and Bayesian network meta-analysis.
Zhang, Q, Dong, J, Zhou, D, Liu, F
International journal of surgery (London, England). 2020;:13-23
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OBJECTIVE Bariatric surgery (malabsorptive [i.e., biliopancreatic diversion, BPD], restrictive [i.e., sleeve gastrectomy, SG; adjustable gastric banding, AGB] and mixed [i.e., gastric bypass, GB] procedures) has been reported to be associated with an increased risk of fracture; however, which procedure poses the greatest risk of fracture is still controversial. The aim of the current meta-analysis was to investigate the degree of fracture risk after different bariatric procedures. MATERIAL AND METHODS Electronic databases, including Medline/PubMed, EMBASE and Cochrane library, were systematically searched from inception to July 11, 2019 with no language restrictions to retrieve randomized controlled trials (RCTs) or cohort studies evaluating the impact of any kind of bariatric surgery on postoperative fractures in patients with obesity. Pairwise meta-analysis and Bayesian network meta-analysis were performed to pool the outcome estimates of interest, including fracture incidence and fracture risk. The values of the surface under the cumulative ranking (SUCRA) probability for fracture risk were calculated and sorted according to the different surgical procedures. RESULTS A total of twelve studies published between 2010 and 2019, comprising 159,916 participants with obesity were identified for the analysis. The incidence of fracture increased from 3% (95% confidence interval [CI] 2-4%) in patients with non-surgical intervention (drug treatment, alteration in life style and diet control) to 5% (95% CI 4-7%) in those who had undergone bariatric surgery (pooled relative risk [RR] = 1.41 95% CI: 1.22-1.63). Network meta-analysis revealed that based on the SUCRA ranking of the different surgical procedures, the malabsorptive procedure had the highest possibility of increased fracture risk in patients with obesity (74.75%), followed by the mixed procedures (73.85%), nonsurgical intervention (43.55%) and the restrictive procedure (7.85%); for different surgery types. The BPD group had the highest possibility of increased fracture risk (99.49%), followed by the GB (74.92%), nonsurgical intervention (44.49%), AGB (26.64%) and SG (4.45%) groups. CONCLUSIONS Significant differences exist among different bariatric surgeries impacting on fracture risk. The malabsorptive and mixed procedures, but not the restrictive procedure, increase the postoperative risk of fracture. Considering the weight-reduction effects and fracture risk, the sleeve gastrectomy procedure may be the best choice for patients with obesity, especially those who are susceptible to osteoporosis.
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Biportal endoscopic versus microscopic lumbar decompressive laminectomy in patients with spinal stenosis: a randomized controlled trial.
Park, SM, Park, J, Jang, HS, Heo, YW, Han, H, Kim, HJ, Chang, BS, Lee, CK, Yeom, JS
The spine journal : official journal of the North American Spine Society. 2020;(2):156-165
Abstract
BACKGROUND CONTEXT Biportal endoscopic decompressive laminectomy is a widely performed procedure and shows acceptable clinical outcomes. However, the evidence regarding the advantages of biportal endoscopic surgery is weak, a randomized controlled trial is therefore warranted. PURPOSE To compare the clinical efficacies of biportal endoscopic and microscopic decompressive laminectomy in patients with lumbar spinal stenosis. STUDY DESIGN Randomized controlled trial. PATIENT SAMPLE Sixty-four participants suffering from low back and leg pain with single-level lumbar spinal stenosis who required decompressive laminectomy. OUTCOME MEASURES Outcomes were assessed with the use of patient-reported outcome measures, visual analog scale (VAS) score for low back and lower extremity radiating pain, Oswestry disability index (ODI), European Quality of Life-5 Dimensions (EQ-5D) score, and painDETECT for neuropathic pain. Surgery-related outcomes including operation time, length of hospital stay, postoperative drainage, and serum creatine phosphokinase were evaluated. Perioperative (<30 days) and late (1-12 months) complications were also noted. METHODS All participants were randomly assigned in a 1:1 ratio to undergo biportal endoscopic or microscopic decompressive laminectomy. The primary outcome was the ODI score at 12 months after surgery based on a modified intention-to-treat strategy. The secondary outcomes included VAS score for low back and lower extremity radiating pain, ODI scores, EQ-5D score, and painDETECT score. There were no sources of funding and no conflicts of interest associated with this study. RESULTS There was no significant difference between groups in the mean ODI score at 12 months after surgery (30 in the microscopy vs. 29 in the biportal endoscopy group, p=.635). There were also no significant differences in low back and lower extremity pain VAS scores, ODI, EQ-5D scores, and painDETECT scores at the 3-, 6-, or 12-month follow-up. Operation time, length of hospital stay, serum creatine phosphokinase, and perioperative complications, such as durotomies and symptomatic hematoma, showed no significant differences between the groups; however, one participant underwent additional revision surgery 9 months after the index surgery in the microscopy group. CONCLUSIONS Despite the study design limitation of relatively short duration of follow-up, this trial suggests that biportal endoscopic decompressive laminectomy is an alternative to and offers similar clinical outcomes as microscopic open surgery in patients with symptomatic lumbar spinal stenosis.