Prospective Nonrandomized Cohort Study Research Articles

Metformin doses and body mass index: clinical outcomes in insulin resistant polycystic ovary syndrome women.

PCOS is the most common endocrinopathy among reproductive age women. Approximately 60% of PCOS women have insulin resistance. While the efficacy of metformin in reducing insulin resistance and decreasing androgen level has been widely validated, there is no agreement on the dose of metformin to be used. Prospective non-randomized cohort study of 108 insulin resistant, overweight and obese PCOS women, aged between 22 and 35 years. All patients received 1500 mg of metformin (500 mg x 3 times/day) for the first 6 months. At the end of this period, the patients' HOMA index was evaluated. In subjects, who did not demonstrate normalization of the HOMA index, the dose was increased to 2500 mg/day (500 mg at breakfast and 1000 mg at lunch and dinner) for additional 6 months. The hormonal blood profile, fasting insulin and fasting glucose levels, HOMA index, anthropometric assessment, pelvic ultrasound, FAI index and cholesterol were evaluated. Overall results showed a good response to metformin therapy in insulin-resistant PCOS patients with BMI >25, while in patients with higher BMI (31.15 ± 0.40), no normalization of HOMA was found. At the higher dose of metformin, obese patients achieved a good response to therapy, with improvement in BMI, menstrual pattern, cholesterol levels and hyperandrogenism. Our results demonstrate a correlation between the required dose of metformin, BMI and hyperandrogenism. The dose of metformin should be adjusted to patients' BMI in order to obtain significant results in terms of clinical, metabolic and hormonal responses.

Patterns of prevalence and contemporary clinical management strategies in complicated acute biliary calculous disease: an ESTES \u2018snapshot audit\u2019 of practice

BackgroundAcute complications of biliary calculi are common, morbid, and complex to manage. Variability exists in the techniques utilized to treat these conditions at an individual surgeon and unit level.AimTo identify, through an international prospective nonrandomized cohort study, the epidemiology and areas of practice variability in management of acute complicated calculous biliary disease (ACCBD) and to correlate them against reported outcomes.MethodsA preplanned analysis of the European Society of Trauma and Emergency Surgery (ESTES) 2018 Complicated Biliary Calculous Disease audit was performed. Patients undergoing emergency hospital admission with ACCBD between 1 October 2018 and 31 October 2018 were included. All eligible patients with acute complicated biliary calculous disease were recorded contemporaneously using a standardized predetermined protocol and a secure online database and followed-up through to 60 days from their admission.EndpointsA two-stage data collection strategy collecting patient demographics, details of operative, endoscopic and radiologic intervention, and outcome metrics. Outcome measures included mortality, surgical morbidity, ICU stay, timing of operative intervention, and length of hospital stay.ResultsThree hundred thirty-eight patients were included, with a mean age of 65 years and 54% were female. Diagnosis at admission were: cholecystitis (45.6%), biliary pancreatitis (21%), choledocholithiasis with and without cholangitis (13.9% and 18%). Index admission cholecystectomy was performed in just 50% of cases, and 28% had an ERCP performed. Morbidity and mortality were low.ConclusionThis first ESTES snapshot audit, a purely descriptive collaborative study, gives rich ‘real world’ insights into local variability in surgical practice as compared to international guidelines, and how this may impact upon outcomes. These granular data will serve to improve overall patient care as well as being hypothesis generating and inform areas needing future prospective study.

Utility of an EHR alert and tool to increase brain tumor awareness in the pediatric emergency department setting

PURPOSE: We sought to determine the utility of an EHR alert and screening tool to identify children presenting to the pediatric emergency department with signs and symptoms that could possibly be related to a brain tumor. METHODS This was a prospective non-randomized cohort study of …

IgH translocation with undefined partners is associated with superior outcome in multiple myeloma patients.

In multiple myeloma (MM), impact of specific chromosomal translocations involving IgH (14q21 locus, including t(4;14), t(11;14), and t(14;16)) has been explored extensively. However, over 15% MM patients harboring IgH translocation with undefined partners have long been ignored. A prospective non-randomized cohort study with a total of 715 newly-diagnosed MM cases was conducted, 13.6% of whom were t(14;undefined) positive. The whole cohort was divided into four groups: no IgH split (47.7%); t(14;undefined) (13.6%); t(11;14) (17.6%); and t(4;14) or t(14;16) group (21.1%). Median OS for the four groups was 84.2, not reached (NR), 58.7, and 44.2months, respectively, with P values for t(14;undefined) vs no IgH split, t(11;14), and t(4;14)/t(14;16) groups of 0.197, 0.022, and 0.001, respectively. In bortezomib-based group, the survival advantage gained by t(14;undefined) group was much more significant compared to t(11;14) and t(4;14)/t(14;16) groups. Importantly, t(14;undefined) turned out to be an independent predictive factor for longer OS of MM patients in multivariate analysis, especially in the context of bortezomib treatment. Similar results were also observed in the PUMCH external validation cohort. Collectively, our data confirmed and externally validated the favorable prognosis of the t(14;undefined) groups, especially in the era of novel agents.

Can the Workplace Limitations Questionnaire Capture Short-term Productivity Losses in Acute Distal Radius Fractures Treated With Operative Fixation Versus Cast Immobilization in the Working Population?

Background: Distal radius fractures (DRFs) contribute substantially to overall morbidity in the elderly population. We believe that accurately capturing total productivity losses is vital to understanding the true economic impact of these injuries in working patients. Methods: We conducted a prospective nonrandomized cohort study and enrolled working patients with DRF treated with either casting or operative fixation. We administered the Workplace Limitations Questionnaire (WLQ, Tufts Medical Center) at the first visit following injury and at 2 weeks, 6 weeks, and 3 months after definitive treatment. The WLQ measures the degree to which employed individuals are experiencing limitations on-the-job due to their health problems and estimates health-related productivity loss. We also calculated the monetary value of work time lost at market value in US dollars. The treatment groups were analyzed for statistical similarity using Student t tests. Results: A total of 30 patients met our study's inclusion criteria. The WLQ index score trended downward in both groups across all time points and was lower in the operative cohort compared with the nonoperative cohort at 6 weeks (1.4% vs 12.9% productivity loss, P = .17). The monetary value of work time lost trended downward across all time points and was lower in the operative cohort compared with the nonoperative cohort ($200.21 vs $2846.90, P = .12). Conclusions: In this pilot study, we successfully applied the WLQ to working patients treated for DRF. The WLQ is effective in capturing short-term productivity losses following DRF and may suggest a decreased at-work burden among patients treated with operative fixation compared with casting.

Role of tranexamic acid in axillary lymph node dissection in breast cancer patients.

Axillary lymph node dissection (ALND) is an important step in the management of node-positive operable breast cancer. It is associated with large amount of axillary drainage and increased risk of wound-related infection. Tranexamic acid (TA) has antifibrinolytic property and is being extensively used in controlling blood loss. However, its role in reducing axillary drainage after ALND is still not well-established. The aim of this study is to evaluate the effectiveness of TA in reducing the axillary drainage, early removal of the drain, and decreasing the wound-related infection in breast cancer patients undergoing ALND. This is a prospective nonrandomized double-armed cohort study. Total of 47 patients were included in the TA group and 46 in the nontranexamic (NTA) group. All the patients in TA group received a single dose of intravenous (IV) TA at the time of induction followed by oral TA for five days after surgery. Both TA and NTA groups had similar proportions of locally advanced breast cancers (57.4% vs 56.5%, P=.90). Majority of them underwent modified radical mastectomy (MRM) (70.2% vs 67.4%, P=.76). Patients in TA group had significantly lower axillary drainage (440ml vs 715.5ml, P=.003) with earlier removal of the drain (8 vs 11days, P=.046). Seroma formation (19.1% vs 32.6%, P=.13) and wound-related infection (4.3% vs 8.7%, P=.43) were nonsignificantly lower in the TA group. Tranexamic acid reduces axillary drainage and facilitates early removal of the drain after axillary lymph node dissection.

Feasibility, patient compliance and acceptability of ovarian cancer surveillance using two serum biomarkers and Risk of Ovarian Cancer Algorithm compared to standard ultrasound and CA 125 among women with BRCA mutations

ObjectiveWe assessed the feasibility, patient acceptability of and compliance of a new surveillance strategy for ovarian cancer surveillance in women with BRCA mutations, based on assessments of serum CA125 and HE4 every 4 months (Risk of Ovarian Cancer Algorithm (ROCA) arm), compared to Standard of Care (SOC) surveillance with CA125 blood tests and pelvic ultrasounds every 6 months. MethodsWomen were recruited 6/13/16–9/11/17 from an integrated health care system in California for this non-randomized prospective cohort study. Women were invited to participate in a novel serum biomarker surveillance strategy using ROCA or they could opt to be in the standard of care control arm with ultrasound and CA 125 every 6 months. Outcomes assessed included compliance, self-reported distress using the Impact of Event Scale (IES) and cancer anxiety using the Cancer Worry Scale. ResultsThere were 159 women in the ROCA arm and 43 in the SOC arm. Overall, compliance was higher in the ROCA arm (83.2%) than in SOC (51.9%), p < 0.0001. Based on the IES, ROCA arm women reported less feelings about intrusion and avoidance at 12 months compared to baseline; the difference approached significance for intrusion (7.6% vs 4.1% severe, p = 0.057) and was statistically significant for avoidance (20.8% vs 9.9% severe, p = 0.034). ConclusionsThis pilot demonstrated that compliance was high with blood tests performed every four months for ovarian cancer surveillance. Moreover, ROCA women had lower stress scores over time than SOC women. Given the lack of clinical utility and poor compliance shown with traditional ultrasound and CA125 tests, further investigation is warranted of longitudinal biomarker surveillance for early detection of ovarian cancer.

Le cheminement clinique systématisé dans les fractures proximales fémorales du sujet âgé améliore les résultats cliniques

ObjectiveThe objective of the current study was to evaluate the implementation of clinical pathways (CPs) in hip fracture management. MethodsIn total, 605 proximal femoral fractures were prospectively included into a hospital data-base. The effects of CPs were evaluated using a pre-during-post design. Different procedural (time to surgery, length of stay, discharge, etc.) and patient outcome parameters (mortality, complications, etc.) were evaluated. ResultsIn both categories, significant changes could be detected during the three-year period. E.g. significant reduction of time to surgery, improvement of discharge management, reduction of internal complications. However, no significant changes could be demonstrated for mortality or revision rate. ConclusionWe could show a relevant improvement with the implementation of clinical pathways for the treatment of proximal femoral fractures in elderly patients. Level of EvidenceIII, prospective non-randomized cohort study.

Intraoperative changes in whole-blood viscosity in patients undergoing robot-assisted laparoscopic prostatectomy in the steep Trendelenburg position with pneumoperitoneum: a prospective nonrandomized observational cohort study

BackgroundThe aim of this study was to investigate the effect of the steep Trendelenburg position (STP) with pneumoperitoneum on whole-blood viscosity (WBV) in patients undergoing robot-assisted laparoscopic prostatectomy (RALP). The study also analyzed the associations of clinical patient-specific and time-dependent variables with WBV and recorded postoperative outcomes.MethodsFifty-eight adult male patients (ASA physical status of I or II) undergoing elective RALP were prospectively analyzed in this study. WBV was intraoperatively measured three times: at the beginning of surgery in the supine position without pneumoperitoneum; after 30 min in the STP with pneumoperitoneum; and at the end of surgery in the supine position without pneumoperitoneum. The WBV at a high shear rate (300 s− 1) was recorded as systolic blood viscosity (SBV) and that at a low shear rate (5 s− 1) was recorded as diastolic blood viscosity (DBV). Systolic blood hyperviscosity was defined as > 13.0 cP at 300 s− 1 and diastolic blood hyperviscosity was defined as > 4.1 cP at 5 s− 1.ResultsThe WBV and incidences of systolic and diastolic blood hyperviscosity significantly increased from the supine position without pneumoperitoneum to the STP with pneumoperitoneum. When RALP was performed in the STP with pneumoperitoneum, 12 patients (27.3%) who had normal SBV at the beginning of surgery and 11 patients (26.8%) who had normal DBV at the beginning of surgery developed new systolic and diastolic blood hyperviscosity, respectively. The degree of increase in WBV after positioning with the STP and pneumoperitoneum was higher in the patients with hyperviscosity than in those without hyperviscosity at the beginning of surgery. Higher preoperative body mass index (BMI) and hematocrit level were associated with the development of both systolic and diastolic blood hyperviscosity in the STP with pneumoperitoneum. All patients were postoperatively discharged without fatal complications.ConclusionsChanges in surgical position may influence WBV, and higher preoperative BMI and hematocrit level are independent factors associated with the risk of hyperviscosity during RALP in the STP with pneumoperitoneum.Trial registrationClinical Research Information Service, Republic of Korea, approval number: KCT0003295 on October 25, 2018.

COVID-19 Convalescent Plasma Treatment of Moderate and Severe Cases of SARS-CoV-2 Infection in Kuwait: A&amp;nbsp;Multicenter Interventional Study

Background: The transfusion of COVID-19 convalescent plasma (CCP) is being considered to improve clinical outcomes in patients with COVID-19 disease. We investigated the effectiveness of CCP therapy in patients withmoderate and severe COVID-19 disease. Methods: This non-randomized prospective cohort study was conducted from May 21, 2020, to June 30, 2020, at four major tertiary hospitals in Kuwait. CCP was administered to 135 patients. The control group comprised 233 patients who received standard treatment. All patients (N=368, median age 54 [range 15-82] years) had laboratory-confirmed SARS-CoV-2 infection and either moderate or severe COVID-19 disease.Findings: CCP treatment was significantly associated with a higher rate of clinical improvement in patients with moderate or severe disease. Among those with moderate COVID-19 disease, time to clinical improvement was 7 daysin the CCP group versus 8 days in the control group (p=0·006). For severe COVID-19 disease, time to clinical improvement was 7 days in the CCP group versus 15.5 days in the control group (p=0·003). In the adjusted analysis, the CCP-treated patients with moderate disease had significantly lower 30-day mortality. Compared to the control group, oxygen saturation improved within 3 days of CCP transfusion, and lymphocyte counts improved from day 7 in patients with moderate disease and day 11 in patients with severe disease. Furthermore, C-reactive protein declined throughout the first 14 days after CCP transfusion. None of the CCP patients developed a serious transfusion reaction.Interpretation: The data show that administration of CCP is a safe treatment option for patients with COVID-19 disease, with a favorable outcome in the rate and time to clinical improvement. Funding: Kuwait Ministry Of Health.Trial Registration: Clinicaltrials.gov NCT04474340.Funding Statement: Kuwait Ministry Of HealthDeclaration of Interests: The authors declare no competing interests.Ethics Approval Statement: The study protocol was approved by the Ethics and Research Committee of Kuwait Ministry of Health (#2020/1417). Written informed consent was obtained from all patients or next of kin. If the patient was unconscious and next of kin not available, the healthcare proxy provided written informed consent.

The quest for optimization of laparoscopic pancreaticoduodenectomy with pancreaticogastrostomy

Background: Pancreatic reconstruction remains the Achilles heel of pancreaticoduodenectomy (PD), especially in minimally invasive surgery. We developed a novel 3D-laparoscopic pancreaticoduodenectomy (3D-LPD) procedure with umbrella-pancreaticogastrostomy (uPG) plus roux-en-y gastroenterostomy (RY-GE) reconstruction, and analysed its outcomes in a prospective non-randomized single-centre cohort study (NCT02671357). Methods: Between March 2014 and March 2017, we performed LPD in 102 consecutive patients. We optimized the LPD procedure in 3 stages and routinely placed a pancreatic stent to secure duct patency. In the 1ststage, we performed LPD as a copy of our standard open PD procedure with telescope-PG plus iso-peristaltic gastroenterostomy (n=21). In the 2ndstage we used a uPG reconstruction instead of telescope-PG (n=29), and in the final stage a uPG plus RY-GE reconstruction instead of the standard iso-peristaltic gastroenterostomy (n=52). Results: In the final-stage LPD clinical pancreatic fistula (cPOPF) occurred in 4%, haemorrhage (PPH) in 4%, and severe complications (TOSGS ≥3a) in 10%. None of the patients developed delayed gastric emptying (DGE). In the 1st- and 2nd-stage LPD the rates of cPOPF were 48% and 31% (p<0.001), PPH 33% and 14% (p=0.003), severe complications 57% and 31% (p<0.001), and DGE 5% and 38% (p<0.001), respectively. Median (range) LOS after final-stage LPD was 9 (3-70) days, as compared to 23 (11-56) days after 1st-stage and 22 (10-72) days after 2nd-stage LPD (p<0.001). Postoperative mortality throughout the 3 stages of LPD was 2%. A 52-year old male patient died due to cPOPF with haemorrhage on day 29 after 1st-stage LPD. An 81-year old female patient died on day 3 after the final-stage LPD due to cardiac arrest based on autopsy-proven cardiac amyloidosis. Conclusions: LPD with uPG plus RY-GE is associated with excellent clinical outcomes and no DGE. Further investigation is warranted before considering replacement of current reconstruction Methods in pancreaticoduodenectomy.

Change in Deferring Time Correlate to Improved Female Sexual Function after Anal Sphincter Repair: A Prospective Study

Background: Many women suffer from sexual problems after anal sphincter tears due to obstetric trauma. Aim: The study aimed to assess changes in sexual function after anal sphincter repair. Methods: The study was a non-randomized prospective observational cohort study. Inclusion of the study was done at the University Hospital, Uppsala, Sweden, between 2002 and 2007. Thirty-nine consecutive female patients admitted for anal sphincter repair were invited to the study. Twenty patients accepted and were included, four were lost to follow up and one was unevaluable (due to the formation of a stoma) leaving a study group of 15 patients. The patients were assessed with questionnaires before surgery and at three and 12 months after surgery. Outcomes: Change in reported sexual activity and dyspareunia. Results: Before surgery, 12/15 patients reported that their sexual life was impaired due to anal incontinence. The corresponding figure at 12 months was 9/15 (p = 0.43). Three patients remained sexually inactive throughout the study, five patients increased their sexual activity and one had decreased activity. Out of the 12 who were active, four stated dyspareunia at baseline, and only one reported dyspareunia at 12 months. The mean Miller incontinence scores at baseline and 12 months were 10.1 and 8.7, respectively. The change in incontinence score did not differ between those with decreased, stable or increased sexual activity. However, there was a definite correlation (r = 0.54 - 0.60, p 0.05) between change in sexual function and deferring time for stool. Clinical Implications: Operative management of anal sphincter tears alone is not curative for sexual problems due to anal incontinence but can be a part of the treatment. Strengths and Limitations: The study is a prospective study of sexual function. The limitations are that the questionnaires were not validated due to lack of such questionnaires at the time of the study and that the study population is quite small. Conclusion: Patients with a sphincter injury and fecal incontinence often have an impaired sexual function. Increased deferring time for stools after surgery increases the likelihood of improved sexual function.

Clinical pathways for geriatric patients with proximal femoral fracture improve process and outcome

ObjectiveThe objective of the current study was to evaluate the implementation of clinical pathways (CPs) in hip fracture management. MethodsSix hundred and five proximal femoral fractures were prospectively included into a hospital data-base. The effects of CPs were evaluated using a pre-during-post design. Different procedural (time to surgery, length of stay, discharge, etc.) and patient outcome parameters (mortality, complications, etc.) were evaluated. ResultsIn both categories significant changes could be detected during the three-year period. E.g. significant reduction of time to surgery, improvement of discharge management, reduction of internal complications. However, no significant changes could be demonstrated for mortality or revision rate. ConclusionWe could show a relevant improvement with the implementation of clinical pathways for the treatment of proximal femoral fractures in elderly patients. Level of evidenceIII, prospective non-randomised cohort study.

ECG Guided Tip Positioning Technique for Peripherally Inserted Central Catheters in a teaching Hospital: Feasibility and Cost-effectiveness Analysis in a Prospective Cohort Study.

Introduction: Peripherally Inserted Central Catheters (PICCs) are venous devices intended for short to medium periods of intravenous treatment. Positioning of the catheter tip at the cavo-atrial junction is necessary for optimum performance of a PICC. Although the ECG guided positioning technique of PICCs has been established elsewhere before, it was relatively unknown in our hospital and our country. In this study we evaluated the safety, effectiveness and cost-effectiveness of ECG guided PICC positioning in our teaching hospital. Methods: All patients who received a PICC in 2016 using ECG guidance were compared to those where fluoroscopy guidance was used in a prospective non-randomized cohort study. Relevant data were extracted from electronic health records. Cost-effectiveness analysis was performed. Results: 162 patients received a PICC using fluoroscopy guidance and 103 patients using ECG guidance in 2016. No significant difference was found in malposition, infection or other complications between these groups. Due to personnel reduction and omission of fluoroscopy costs, cost reduction for each catheter insertion was €120 in the first year and, as a result of discounted acquisition costs, €190 in subsequent years. Conclusion: The positioning results and complication rate are comparable to previously reported literature. The cost reduction may vary in different hospitals. Other benefits of the ECG guided technique are omission of X-ray exposure and improved patient service. We concluded that implementation of ECG guided tip positioning for PICC was safe and effective in this study and lead to an improved high value and cost-conscious care.

Preliminary Normative Standards of the Mayo Clinic Esophagectomy CONDUIT Tool.

ObjectiveTo collect patient-reported outcomes after esophagectomy to establish a set of preliminary normative standards to aid in symptom-score interpretation.Patients and MethodsPatients undergoing esophagectomy often have little understanding about postoperative symptom management. The Mayo Clinic esophageal CONDUIT tool is a validated questionnaire comprising 5 multi-item symptom-assessment domains and 2 health-assessment domains. A prospective nonrandomized cohort study was conducted on adult patients who have had esophagectomies using the CONDUIT tool from August 17, 2015, to July 30, 2018 (NCT02530983). The Statistical Analysis System v9.4 (SAS Institute Inc., Cary, NC) was used to calculate and analyze the scores.ResultsOver the study period, 569 patients were assessed for eligibility, and 241 patients consented and were offered the tool. Of these, 188 patients (median age: 65 years; range: 24 to 87 years; 80% male patients) had calculable scores. Of the 188 patients, 50 (26.6%) patients were identified as potential beneficiaries for educational intervention to improve symptoms (received moderate scores for a domain), and 131 (69.7%) patients were identified as needing further testing or provider intervention (received poor scores for a domain) based on the tool.ConclusionThe CONDUIT tool scores, when compared with standardized scales with established preliminary normative scores, could be used to identify and triage patients who need targeted education, further testing, or provider interventions. These score ranges will serve as the first set of normative standards to aid in the interpretation of conduit performance among providers and patients.

Diagnostic Performances of Tridimensional Rectosonography and Magnetic Resonance Imaging in Rectosigmoid Endometriosis: A Prospective Cohort Study on 101 Patients

Tridimensional rectosonography (3-D RSG) is a transvaginal ultrasonography procedure combining intrarectal contrast with tridimensional technology. The objectives of this study were to assess the diagnostic performances of 3-D RSG in deep infiltrating rectosigmoid endometriosis using surgery and pathology as the gold standard, and to compare its results with those of magnetic resonance imaging (MRI). Patients referred for endometriosis with symptoms suggesting deep infiltrating intestinal endometriosis (DIE) were included if they agreed to undergo a 3-D RSG and MRI and if there was a surgical indication related to endometriosis. The study was a non-randomized monocentric prospective cohort study (Canadian task force classification Level II-2). From May 2012 to May 2017, 101 patients were included. Sixty patients (59.4%) had bowel involvement of the rectum (n = 21, 20.8%) or of the sigmoid (n = 39, 38.6%) confirmed in surgery and/or in pathologic testing. In the diagnosis of rectosigmoid DIE, 3-D RSG sensitivity, specificity, positive predictive value, negative predictive value, accuracy and κ index were 93%, 95%, 97%, 91%, 94% and 0.88, respectively. For MRI they were 87%, 90%, 93%, 82%, 88% and 0.76, respectively. The accuracy was not significantly different between 3-D RSG and MRI (p = 0.181). In conclusion, 3-D RSG is an effective technique to diagnose rectosigmoid endometriosis and seems to have similar diagnostic performances to MRI for this indication.

Effectiveness and safety of conservative management of occult pneumothorax in mechanically ventilated patients: a systematic review protocol.

This systematic review aims to synthesize the available evidence investigating the effectiveness and safety of conservative management of occult pneumothorax in mechanically ventilated patients. Occult pneumothorax is air within the pleural cavity that is diagnosed on a CT scan but was not suspected on the basis of preceding clinical examination or supine chest x-ray. Currently, there is no consensus on how to manage occult pneumothoraces, especially in patients requiring mechanical ventilation. It is common practice to place a prophylactic intercostal catheter to stop the potential development of a tension pneumothorax; however, there is a 20% risk of major complications from the intercostal catheter insertion. Recent evidence suggests that occult pneumothorax in mechanically ventilated patients can be managed conservatively, rather than using a prophylactic intercostal catheter as first-line management. This review will include studies investigating stable patients of all ages who were diagnosed with traumatic occult pneumothorax via CT scan, received mechanical ventilation, and underwent either conservative management or intercostal catheter insertion. Eligible studies will include randomized and non-randomized controlled trials, and prospective and retrospective cohort studies. PubMed, Embase, CINAHL, Web of Science, and Cochrane Central Register of Controlled Trials will be searched. International Clinical Trials Registry, Australian New Zealand Clinical Trials Registry, and ClinicalTrials.gov will be searched for unpublished studies. All included studies will be critically appraised using standardized JBI tools, with no exclusions based on methodological quality. Studies will, where possible, be pooled in statistical meta-analysis, with impact of methodological quality to be explored through sensitivity analysis.

Alcohol-based mouthwash as a risk factor of oral cancer: A systematic review.

Background Oral and pharynx cancer represent a serious global problem, reaching an incidence of half a million cases annually. The role of tobacco and alcohol have been studied and proven to be one of its risk factors. We also know that mouthwashes contain a variable percentage of alcohol, so there is a reasonable concern about their role in carcinogenesis. Material and Methods To answer the PICOS (Population; Intervention; Comparison; Outcomes; Study) question: "Do patients (Population) who use alcohol-based mouthwashes (Intervention) compared to those who do not use them (Comparison) have higher acetaldehyde levels in saliva or higher risk of oral cancer development? (Outcomes)" Meta-analyses, systematic reviews, randomized and non-randomized clinical trials, case-control studies, and prospective and retrospective cohort studies were included (Study). Two independent authors conducted literature screening through MEDLINE, Scopus and the Cochrane Library, and they also conducted article and data extraction to undertake quality analyses. The main outcome measures were salivary acetaldehyde levels or the risk of oral cancer development. The most relevant data was extracted and the risk of bias from the studies included was also evaluated. Results Out of 497 potentially eligible papers, 8 studies were included in the qualitative analysis which include a total of 43,499 subjects: two meta-analyses, a clinical trial, three case-control studies and two cohort studies. One study (n = 3,926) found a relationship between alcohol mouthwash and oral cancer, two studies (n = 25,033) found this relationship when a high frequency of mouthwash was present, three studies (n = 14,482) failed to find this relationship and 2 studies (n = 58) found a temporary increase of acetaldehyde levels in saliva after alcohol mouthwash. Conclusions It cannot be guaranteed that the use of mouthwash represents an independent risk factor for the development of head and neck cancer. However, the risk does increase when it occurs in association with other carcinogenic risk factors. Key words:Oral Cancer, Oropharyngeal Neoplasms, Mouthwashes, Mouth rinse, Ethanol, Acetaldehyde, alcohol.

The Impact of Enhanced Recovery after Surgery on Outpatient Recovery after Laparoscopic Hysterectomy

Study Objective Enhanced Recovery after Surgery (ERAS) pathways have led to improved perioperative outcomes in hospital quality of care and cost parameters in gynecologic surgery. There is less data on the impact of ERAS on patient-reported recovery experience after laparoscopic hysterectomy in the outpatient setting. Design An IRB-approved single-blinded non-randomized prospective cohort study compared two cohorts of patients who underwent laparoscopic hysterectomy: perioperative ERAS protocol or standard perioperative care at a single institution. Surveys were distributed to patients at their initial postoperative appointment. Setting Urban academic-affiliated community tertiary care center. Patients or Participants Women undergoing laparoscopic hysterectomy by high volume surgeons (>10 hysterectomies per year). Interventions Perioperative ERAS protocol; postoperative self-administered survey 2 weeks after surgery. Measurements and Main Results Between 8/1/18 and 4/9/19, 73 patients undergoing laparoscopic hysterectomy were surveyed: 37 (ERAS) cases and 44 under standard perioperative care (controls). 8 surveys from the control group were excluded due to predefined criteria. The patients responded to Likert scaled questions regarding ability to perform daily activities (ascending difficulty from 1 to 5). Conclusion Implementation of ERAS does not adversely affect self-reported patient recovery. At two weeks following laparoscopic hysterectomy, the majority of patients returned to baseline physical activity, bowel function, appetite & diet, and required no additional narcotic medications.

Effect of preoperative stoma site marking on early and late outcomes of intestinal stoma creation

Purpose To evaluate how preoperative markings of the stoma site influence patients’ quality of life (QOL), whether they improve patients’ independence, and what is their effect on the rates of postoperative early and late complications. Patients and methods This is a nonrandomized prospective cohort study that included 60 patients who underwent elective intestinal stoma creation in Alexandria Main University Hospital. Patients were divided into two groups. Group A included 30 patients who experienced preoperative marking of their stoma site according to the educational guide developed by the American Society of Colon and Rectal Surgeons and the Wound, Ostomy and Continence Nurse Society, and group B included 30 patients who did not experience preoperative marking of their stoma site. A structured, validated questionnaire was used to assess patients’ QOL and the stoma QOL 1 month after surgery. The occurrence of complications was noted during regular outpatient follow-up encounters, with median follow-up of 1 year, and was evaluated by stoma and equipment-related complication scale. Results A total of 60 patients (48.3% females and 51.7% males) were included. Their mean age was 48.32±14.10 years. It was found that the QOL score of patients whose stoma site was marked (group A) was significantly better (45.03–65.01 vs. 33.58–56.19). Overall satisfaction was significantly better in group A (5.27±1.78 vs. 2.73±2.32). Conclusion The patients whose stoma sites were preoperatively marked had significantly better QOL and significantly fewer early postoperative complications, and these results are irrespective of the stoma type.