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"Postoperative Care - methods"
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A multidisciplinary, multifactorial intervention program reduces postoperative falls and injuries after femoral neck fracture
by
Nyberg, L.
,
Englund, U.
,
Stenvall, M.
in
Accidental Falls - prevention & control
,
Aged
,
Aged, 80 and over
2007
This study evaluates whether a postoperative multidisciplinary, intervention program, including systematic assessment and treatment of fall risk factors, active prevention, detection, and treatment of postoperative complications, could reduce inpatient falls and fall-related injuries after a femoral neck fracture.
A randomized, controlled trial at the orthopedic and geriatric departments at Umeå University Hospital, Sweden, included 199 patients with femoral neck fracture, aged >or=70 years.
Twelve patients fell 18 times in the intervention group compared with 26 patients suffering 60 falls in the control group. Only one patient with dementia fell in the intervention group compared with 11 in the control group. The crude postoperative fall incidence rate was 6.29/1,000 days in the intervention group vs 16.28/1,000 days in the control group. The incidence rate ratio was 0.38 [95% confidence interval (CI): 0.20 - 0.76, p=0.006] for the total sample and 0.07 (95% CI: 0.01-0.57, p=0.013) among patients with dementia. There were no new fractures in the intervention group but four in the control group.
A team applying comprehensive geriatric assessment and rehabilitation, including prevention, detection, and treatment of fall risk factors, can successfully prevent inpatient falls and injuries, even in patients with dementia.
Journal Article
Optimal drainage time after evacuation of chronic subdural haematoma (DRAIN TIME 2): a multicentre, randomised, multiarm and multistage non-inferiority trial in Denmark
2024
Postoperative drainage after surgical evacuation of chronic subdural haematoma reduces the risk of recurrence, but the optimum drainage time is uncertain. We aimed to investigate the shortest possible drainage time without increasing the haematoma recurrence rate.
We conducted a randomised, multi-arm and multistage non-inferiority trial at four neurosurgical centres in Denmark. We enrolled adult patients (aged ≥18 years) with symptomatic chronic subdural haematoma. All patients were treated according to the national standard practice with a burr hole above the maximum width of the haematoma. Patients were randomly assigned in a 1:1:1 ratio via a centralised web server to receive 6 h, 12 h, or 24 h of postoperative passive subdural drainage. Randomisation was done by an independent on-call neurosurgeon and was masked until 6 h after surgery. The primary outcome was symptomatic haematoma recurrence at 3 months after surgery; the rate of recurrence was assessed in a regression model for non-inferiority testing, with no missing data. Personnel assessing the primary outcome were masked to group allocation. Non-inferiority was assessed with a prespecified margin of 7%, in a modified intention-to-treat population—defined as patients with randomly assigned treatment excluding those withdrawing from study participation after randomisation, or experiencing acute rebleedings or accidental drain removal. This trial is registered with ISRCTN (number 15186366); the trial was stopped after the first interim analysis on the advice of an independent safety advisory committee.
Between March 1, 2021, and June 30, 2022, 347 patients were enrolled and 331 were followed up to 3 months, 105 were assigned to 6 h of drainage, 111 to 12 h of drainage, and 115 to 24 h of drainage. At admission, 83 (25%) participants were women and 248 (75%) were men, mean age was 75·7 years (SD 10·5), median modified Rankin Scale score was 4 (IQR 3–5), and median Glasgow Coma Scale score was 15 (IQR 14–15). At 3 months after surgery, haematoma recurrence was reported in 28 (27%) of 105 patients who were assigned to 6 h drainage (predicted haematoma recurrence rate 27·0%, 95% CI 18·5 to 35·4), 22 (20%) of 111 assigned to 12 h drainage (19·5%, 12·0 to 27·0), and 12 (10%) of 115 assigned to 24 h drainage (10·4%, 4·8 to 16·0). The risk of haematoma recurrence was increased by 16·5 percentage points (95% CI 6·5 to 26·6) in patients drained for 6 h compared with 24 h, and by 9·1 percentage points (–0·4 to 18·5) in patients drained for 12 h compared with 24 h. Therefore, non-inferiority of 6 h and 12 h of drainage to 24 h of drainage was not established. 20 patients had died by 3 months, seven in the 6 h group, eight in the 12 h group, and five in the 24 h group. The most frequent known causes of death were haematoma recurrence (three in 12 h group), comorbidity (three in 12 h group), and pneumonia (one each in 6 h and 12 h groups, two in 24 h group). The most frequent complication was postoperative infection, reported in 20 (20%) patients in the 6 h group, 25 (23%) in the 12 h group, and 19 (17%) in the 24 h group. The most common infection source was the urinary tract.
Patients surgically treated for symptomatic chronic subdural haematoma and postoperatively drained for 6 h or 12 h had higher rates of haematoma recurrence than did patients drained for 24 h. The findings from this non-inferiority trial provide evidence to support 24 h of postoperative drainage as the standard drain time when a fixed drain time approach is used. To provide solid evidence of generalisability of the results to countries other than Denmark, a multinational randomised controlled trial will be needed.
None.
Journal Article
Pre-optimization of spinal surgery patients: Development of a neurosurgical enhanced recovery after surgery (ERAS) protocol
2018
•Enhanced recovery after surgery (ERAS) is multimodal pathway that aims to optimize patient outcomes.•ERAS addresses pre-, peri-, and post-operative factors in elective spinal and peripheral nerve patients.•ERAS provides a platform to engage the multidisciplinary team associated with a patient’s surgical journey.
Despite surgical, technological, medical, and anesthetic improvements, patient outcomes following elective neurosurgical procedures can be associated with high morbidity. Enhanced recovery after surgery (ERAS) protocols are multimodal care pathways designed to optimize patient outcomes by addressing pre-, peri-, and post-operative factors. Despite significant data suggesting improved patient outcomes with the adoption of these pathways, development and implementation has been limited in the neurosurgical population.
This study protocol was designed to establish the feasibility of a randomized controlled trial to assess the efficacy of implementation of an ERAS protocol on the improvement of clinical and patient reported outcomes and patient satisfaction scores in an elective inpatient spine surgery population. Neurosurgical patients undergoing spinal surgery will be recruited and randomly allocated to one of two treatment arms: ERAS protocol (experimental group) or hospital standard (control group). The experimental group will undergo interventions at the pre-, peri-, and post-operative time points, which are exclusive to this group as compared to the hospital standard group.
The present proposal aims to provide supporting data for the application of these specific ERAS components in the spine surgery population and provide rationale/justification of this type of care pathway. This study will help inform the design of a future multi-institutional, randomized controlled trial.
of this study will guide further efforts to limit post-operative morbidity in patients undergoing elective spinal surgery and to highlight the impact of ERAS care pathways in improving patient reported outcomes and satisfaction.
Journal Article
Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial
2016
Rectal indometacin decreases the occurrence of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP). However, the population most at risk and the optimal timing of administration require further investigation. We aimed to assess whether pre-procedural administration of rectal indometacin in all patients is more effective than post-procedural use in only high-risk patients to prevent post-ERCP pancreatitis.
We did a multicentre, single-blinded, randomised controlled trial at six centres in China. Eligible patients with native papilla undergoing ERCP were randomly assigned in a 1:1 ratio (with a computer-generated list) to universal pre-procedural indometacin or post-procedural indometacin in only high-risk patients, with stratification by trial centres and block size of ten. In the universal indometacin group, all patients received a single dose (100 mg) of rectal indometacin within 30 min before ERCP. In the risk-stratified, post-procedural indometacin group, only patients at predicted high risk received rectal indometacin, immediately after ERCP. Investigators, but not patients, were masked to group allocation. The primary outcome was overall ocurrence of post-ERCP pancreatitis. The analysis followed the intention-to-treat principle. This study was registered with ClinicalTrials.gov, number NCT02002650.
Between Dec 15, 2013, and Sept 21, 2015, 2600 patients were randomly assigned to universal, pre-procedural indometacin (n=1297) or risk-stratified, post-procedural indometacin (n=1303). Overall, post-ERCP pancreatitis occurred in 47 (4%) of 1297 patients assigned to universal indometacin and 100 (8%) of 1303 patients assigned to risk-stratified indometacin (relative risk 0·47; 95% CI 0·34–0·66; p<0·0001). Post-ERCP pancreatitis occurred in 18 (6%) of 305 high-risk patients in the universal group and 35 (12%) of 281 high-risk patients in the risk-stratified group (p=0·0057). Post-ERCP pancreatitis was also less frequent in average-risk patients in the universal group (3% [29/992]), in which they received indometacin, than in the risk-stratified group (6% [65/1022]), in which they did not receive the drug (p=0·0003). Other than pancreatitis, adverse events occurred in 41 (3%; two severe) patients in the universal indometacin group and 48 (4%; one severe) patients in the risk-stratified group. The most common adverse events were biliary infection (22 [2%] patients vs 33 [3%] patients) and gastrointestinal bleeding (13 [1%] vs ten [1%]).
Compared with a risk-stratified, post-procedural strategy, pre-procedural administration of rectal indometacin in unselected patients reduced the overall occurrence of post-ERCP pancreatitis without increasing risk of bleeding. Our results favour the routine use of rectal indometacin in patients without contraindications before ERCP.
National Key Technology R&D Program, National Natural Science Foundation of China.
Journal Article
Outcomes of low-level light therapy before and after cataract surgery for the prophylaxis of postoperative dry eye: a prospective randomised double-masked controlled clinical trial
by
Carnovale Scalzo, Giovanna
,
Giannaccare, Giuseppe
,
Borselli, Massimiliano
in
Aged
,
Aged, 80 and over
,
Cataract Extraction
2024
BackgroundDespite increasing evidence shows that optimising ocular surface before cataract surgery is fundamental in patients with pre-existing dry eye disease (DED) to achieve the desired postoperative outcomes, the prophylactic treatment of healthy patients undergoing surgery aiming at preventing iatrogenic DED is worth investigating.MethodsThis was a prospective, interventional, randomised, controlled, double-masked clinical trial. Patients were randomly assigned 1:1 to receive either low-level light therapy (LLLT) or sham treatment (LLLT with a power output <30%). Patients underwent two treatment sessions: 7±2 days before cataract surgery (T0) and 7±2 days after (T1). Outcome measures evaluated 30±4 days after surgery (T2) included Ocular Surface Disease Index (OSDI) questionnaire, non-invasive break-up time (NIBUT), tear meniscus height, meibomian gland loss (MGL) and redness score.ResultsOut of 153 patients randomised to receive LLLT (n=73) or sham treatment (n=80), 131 (70 men, 61 women, mean age 73.53±7.29 years) completed regularly the study. Patients treated with LLLT had significantly lower OSDI scores compared with controls at T1 and T2 (respectively, 7.2±8.8 vs 14.8±13.0 and 9.0±9.0 vs 18.2±17.9; both p<0.001), higher NIBUT values at T2 (12.5±6.6 vs 9.0±7.8; p=0.007) and lower MGL Meiboscore values at T1 (1.59±0.70 vs 1.26±0.69; p=0.008). Unlike controls, patients treated with LLLT had significantly lower OSDI scores and higher NIBUT values at T2 compared with T0 (respectively, 9.0±9.0 vs 21.2±16.1; p<0.001 and 12.5±6.6 vs 9.7±7.2; p=0.007).ConclusionTwo sessions of LLLT performed before and after cataract surgery were effective in ameliorating tear film stability and ocular discomfort symptoms.Trial registration numberNCT05754437.
Journal Article
Approach to postpancreatectomy care Impacts outcomes: Retrospective Validation of the PORSCH trial
2024
In the recent PORSCH trial, a three-part postpancreatectomy care algorithm was employed with a near 50 % reduction in mortality. We hypothesized that clinical care congruent with this protocol would correlate with better outcomes in our patients.
Real-world postoperative care was compared to the pathway described by the PORSCH trial and patients were assigned into groups based on congruence with its recommendations. The primary composite outcome (PCO) consisted of 90-day mortality, organ failure, and interventions for bleeding.
Of 289 patients, care of 12 % was entirely congruent with the PORSCH algorithm. The PCO was recorded in 9 % of the PORSCH care group, 8 % of the Partial-PORSCH care group, and 19 % of the Non-PORSCH care group (p = 0.044). Adverse outcomes were highest when pancreaticoduodenectomy patients received care incongruent with the algorithm's CT imaging recommendations.
These results add external validity to the principles of clinical care underlying the PORSCH algorithm.
[Display omitted]
•Derangements in labwork and vital signs after pancreatectomy warrant investigation.•Early detection and treatment of postpancreatectomy complications improves outcomes.•The PORSCH trial's algorithm may reduce morbidity and mortality in clinical practice.
Journal Article
Liberal versus restrictive blood transfusion strategy: 3-year survival and cause of death results from the FOCUS randomised controlled trial
by
Sieber, Frederick
,
Hoover, Donald R
,
Macaulay, William
in
Aged
,
Aged, 80 and over
,
Anemia - blood
2015
Blood transfusion might affect long-term mortality by changing immune function and thus potentially increasing the risk of subsequent infections and cancer recurrence. Compared with a restrictive transfusion strategy, a more liberal strategy could reduce cardiac complications by lowering myocardial damage, thereby reducing future deaths from cardiovascular disease. We aimed to establish the effect of a liberal transfusion strategy on long-term survival compared with a restrictive transfusion strategy.
In the randomised controlled FOCUS trial, adult patients aged 50 years and older, with a history of or risk factors for cardiovascular disease, and with postoperative haemoglobin concentrations lower than 100 g/L within 3 days of surgery to repair a hip fracture, were eligible for enrolment. Patients were recruited from 47 participating hospitals in the USA and Canada, and eligible participants were randomly allocated in a 1:1 ratio by a central telephone system to either liberal transfusion in which they received blood transfusion to maintain haemoglobin level at 100 g/L or higher, or restrictive transfusion in which they received blood transfusion when haemoglobin level was lower than 80 g/L or if they had symptoms of anaemia. In this study, we analysed the long-term mortality of patients assigned to the two transfusion strategies, which was a secondary outcome of the FOCUS trial. Long-term mortality was established by linking the study participants to national death registries in the USA and Canada. Treatment assignment was not masked, but investigators who ascertained mortality and cause of death were masked to group assignment. Analyses were by intention to treat. The FOCUS trial is registered with ClinicalTrials.gov, number NCT00071032.
Between July 19, 2004, and Feb 28, 2009, 2016 patients were enrolled and randomly assigned to the two treatment groups: 1007 to the liberal transfusion strategy and 1009 to the restrictive transfusion strategy. The median duration of follow-up was 3·1 years (IQR 2·4–4·1 years), during which 841 (42%) patients died. Long-term mortality did not differ significantly between the liberal transfusion strategy (432 deaths) and the restrictive transfusion strategy (409 deaths) (hazard ratio 1·09 [95% CI 0·95–1·25]; p=0·21).
Liberal blood transfusion did not affect mortality compared with a restrictive transfusion strategy in a high-risk group of elderly patients with underlying cardiovascular disease or risk factors. The underlying causes of death did not differ between the trial groups. These findings do not support hypotheses that blood transfusion leads to long-term immunosuppression that is severe enough to affect long-term mortality rate by more than 20–25% or cause of death.
National Heart, Lung, and Blood Institute.
Journal Article
The nursing application of multifunctional protective pants after posterior urethral stricture surgery A randomized clinical trial
2025
Posterior urethral stricture is a severe disease in urology, and end-to-end urethral anastomosis remains the gold standard treatment. The surgical outcome not only depends on meticulous intraoperative management but also on postoperative care. Key aspects of postoperative care include stable compression bandaging, prevention of skin tension and allergic blistering, and preventing penile from erection. We have produced a multifunctional protective pant that is expected to prove its effectiveness through a randomized controlled study. This study included 50 patients who were divided into an experimental group and a control group. The patients in the experimental group wore the protective pants immediately after surgery. On the basis of routine care in the control group, health education and guidance for patients and family members on wearing protective pants were added. During the postoperative period until discharge, we observed the occurrence of wound bleeding, abnormal body temperature, and evaluated patient infection status based on results such as blood routine and procalcitonin. A numerical scoring table was used for pain assessment during the three days and nine shifts handover of patients. Patient feedback during pants usage was obtained through a self-assessment questionnaire two months after surgery. On the second day after surgery, the incidence of scrotum oedema in the experimental group was significantly lower than that in the control group, with a statistically significant difference (P < 0.05). Within five days after surgery, the experimental group had a significantly lower incidence of wound bleeding, skin allergic blisters and erectile pain compared to the control group, with a statistically significant difference (P < 0.05). The use of the protective pants effectively reduced postoperative complications during the perioperative period, and significantly improving surgical success rates and patient satisfaction.
Journal Article
A Randomized Clinical Trial of Laparoscopic Roux-en-Y Gastric Bypass and Sleeve Gastrectomy for the Treatment of Morbid Obesity in China: a 5-Year Outcome
2014
Background
No randomized comparative trials have presented long-term outcomes for laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB). The present study was designed to compare the efficacy and safety of these two procedures.
Methods
From January 2007 to July 2008, 64 eligible patients were randomly assigned to LSG or LRYGB. During the 5-year follow-up, we compared morbidity rate, body mass index (BMI), percent of excess weight loss (%EWL), Moorehead-Ardelt (M-A) II quality of life, and resolution or improvement rate of obesity-related comorbidities between the groups.
Results
Both groups were matched with respect to age, gender, and BMI. Slightly more major complications were observed in patients undergoing LRYGB (
P
> 0.05). Weight loss was significantly better with LRYGB except during the first postoperative year. At 5 years, %EWL for LSG and LRYGB was 63.2 ± 24.5 % and 76.2 ± 21.7 % (
P
= 0.02), respectively. No statistical difference was observed in quality of life between the groups at all intervals (
P
> 0.05). At the last follow-up, most comorbidities in both groups were resolved or improved, with no difference between the groups (
P
> 0.05).
Conclusion
LRYGB and LSG are equally safe and effective in quality of life and improvement or resolution of comorbidities, and LRYGB possesses the superiority in terms of weight loss. Further studies are needed to evaluate micronutrient deficiencies of these procedures.
Journal Article
The impact of the incorporation of a feasible postoperative mortality model at the Post-Anaesthestic Care Unit (PACU) on postoperative clinical deterioration: A pragmatic trial with 5,353 patients
by
Stefani, Luciana Cadore
,
Silveira Martins, Otávio Ritter
,
Caumo, Wolnei
in
Adolescent
,
Adult
,
Aged
2021
Practical use of risk predictive tools and the assessment of their impact on outcome reduction is still a challenge. This pragmatic study of quality improvement (QI) describes the preoperative adoption of a customised postoperative death probability model (SAMPE model) and the evaluation of the impact of a Postoperative Anaesthetic Care Unit (PACU) pathway on the clinical deterioration of high-risk surgical patients.
A prospective cohort of 2,533 surgical patients compared with 2,820 historical controls after the adoption of a quality improvement (QI) intervention. We carried out quick postoperative high-risk pathways at PACU when the probability of postoperative death exceeded 5%. As outcome measures, we used the number of rapid response team (RRT) calls within 7 and 30 postoperative days, in-hospital mortality, and non-planned Intensive Care Unit (ICU) admission.
Not only did the QI succeed in the implementation of a customised risk stratification model, but it also diminished the postoperative deterioration evaluated by RRT calls on very high-risk patients within 30 postoperative days (from 23% before to 14% after the intervention, p = 0.05). We achieved no survival benefits or reduction of non-planned ICU. The small group of high-risk patients (13% of the total) accounted for the highest proportion of RRT calls and postoperative death.
Employing a risk predictive tool to guide immediate postoperative care may influence postoperative deterioration. It encouraged the design of pragmatic trials focused on feasible, low-technology, and long-term interventions that can be adapted to diverse health systems, especially those that demand more accurate decision making and ask for full engagement in the control of postoperative morbi-mortality.
Journal Article