Ethical Review Board Approval Research Articles

Thirty-day Morbidity and Mortality after Radical Cystectomy in Carcinoma Urinary Bladder; A Single Centre Experience

Objective: To determine the 30-day morbidity and mortality after radical cystectomy in carcinoma urinary bladder using a validated system. Study Design: Retrospective longitudinal study. Place and Duration of study: Armed Forces Institute of Urology, Rawalpindi Pakistan, from Jun 2016 to Jul 2021. Methodology: After Institutional Ethical Review Board approval, data of all patients of carcinoma urinary bladder who underwent radical cystectomy during five years at Armed Forces Institute of Urology, was collected. Data was retrieved retrospectively from the hospital operative database, indoor patient records and by contacting the patients on their given telephone numbers. Results: In the study population (n=39), a male preponderance was found (36,92.3%). Mean age was 56.7±8.96 years (range 32-72). 26(66.7%) patients were smokers and 16(41%) received neoadjuvant chemotherapy. 9(23.7%) patients had Clavien-DindoGrade-I complications, 6(15.38%) had Grade-II, 2(5.12%) had Grade- IIIA, 2(5.12%) Grade IIIB, 1(2.56%) Grade-IVA, 1(2.56%)had Grade IVB, 2(5.12%) had Grade V complications. The total complications were 23(58.97%), and 16(41.03%) patients had nopost-operative complications. 21(53.85%) patients had less than 14 days post-op operative hospital stay, and 18(46.15%) hadmore than 14 days post-op operative hospital stay. Conclusion: Radical cystectomy is still associated with high early post-op mortality and morbidity. Careful patient selection and thorough counselling before the procedure are very important.

Utilisation of the Scepter Mini dual-lumen balloon - An illustrative series.

Dual-lumen balloon microcatheters can aid in the safety and efficacy of endovascular embolisation of cerebrospinal vascular malformations. The Scepter Mini dual-lumen balloon is a novel device with a smaller profile than previous balloon microcatheters, opening up new indications not only in the treatment of cerebrospinal malformations but in various other neurovascular therapeutic and diagnostic scenarios. Following institutional ethics review board approval, a retrospective review of our prospectively maintained database of cases employing the Scepter Mini dual-lumen microballoon catheter was conducted. Five cases in particular were highlighted, demonstrating utilisation of this device, which may be of interest to the Neurointerventionalist. Patient demographics, procedure details, complications and clinical outcome data were reviewed. Five cases employing the Scepter Mini dual-lumen microballoon catheter are presented; trans-arterial embolisation of cerebral AVM, pre-operative tumour embolisation, diagnostic angiography, trans-venous embolisation of cerebral AVM and trans-arterial embolisation of DAVF. No intraprocedural complications were recorded, one patient had a delayed haemorrhage. Potential utilisation of the Scepter Mini lies not only in the trans-arterial embolisation of cerebrospinal vascular malformations, but in a range of other diagnostic and therapeutic indications as demonstrated.

Barriers to and facilitators of effective management of fever episodes in hospitalised Kenyan children with cancer: protocol for convergent mixed methods study

IntroductionFebrile neutropenia is an oncological emergency in children with cancer, associated with serious infections and complications. In low-resourced settings, death from infections in children with cancer is 20 times higher...

Histologic Activity in Inflammatory Bowel Disease and Risk of Serious Infections: A Nationwide Study

Individuals with inflammatory bowel disease (IBD) are at increased risk of serious infections, but whether this risk varies by histologic disease activity is unclear. This was a national population-based study of 55,626 individuals diagnosed with IBD in 1990 to 2016 with longitudinal data on ileocolorectal biopsy specimens followed up through 2016. Serious infections were defined as having an inpatient infectious disease diagnosis in the Swedish National Patient Register. We used Cox regression to estimate hazard ratios (HRs) for serious infections in the 12 months after documentation of histologic inflammation (vs histologic remission), adjusting for social and demographic factors, chronic comorbidities, prior IBD-related surgery, and hospitalization. We also adjusted for IBD-related medications in sensitivity analyses. With histologic inflammation vs remission, there was 4.62 (95% CI, 4.46-4.78) and 2.53 (95% CI, 2.36-2.70) serious infections per 100 person-years of follow-up, respectively (adjusted HR [aHR], 1.59; 95% CI, 1.48-1.72). Histologic inflammation (vs remission) was associated with an increased risk of serious infections in ulcerative colitis (aHR, 1.68; 95% CI, 1.51-1.87) and Crohn's disease (aHR, 1.59; 95% CI, 1.40-1.80). The aHRs of sepsis and opportunistic infections were 1.66 (95% CI, 1.28-2.15) and 1.71 (95% CI, 1.22-2.41), respectively. Overall, results were consistent across age groups, sex, and education level, and remained largely unchanged after adjustment for IBD-related medications (aHR, 1.47; 95% CI, 1.34-1.61). Histologic inflammation of IBD was an independent risk factor of serious infections, including sepsis, suggesting that achieving histologic remission may reduce infections in IBD. The study was approved by the Stockholm Ethics Review Board (approval numbers 2014/1287-31/4, 2018/972-32, and 2021-06209-01).

Technologies for the diagnosis of angle closure glaucoma (ACE): protocol of a prospective, multicentre, cross-sectional diagnostic study

IntroductionAngle-closure is responsible for half of all glaucoma blindness globally. Patients with suspected glaucoma require assessment of the drainage angle by an experienced clinician. The goal of this study is...

Quality of reporting for qualitative studies in pediatric urology—A scoping review

Qualitative research has gained popularity in pediatric urology due to rich data and insights about quantitative results. To date, there has been no study evaluating the comprehensiveness of the reporting of these studies based on established guidelines. The objective of this study is to perform a scoping review of the quality of reporting in recent qualitative studies in pediatric urology based on a predominant checklist, the 21-item Standards of Reporting Qualitative Research (SRQR) and identify areas for improvement. In accordance with the Preferred Reported Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews, we performed a systematic literature search to identify qualitative studies on pediatric urology topics published from 2015 to 2021. We used clustering technology to eliminate articles with unrelated keywords. Articles not in English and those published prior to 2015 were excluded. Two reviewers performed title/abstract screening and full text review and resolved discrepancies by consensus. We reported the median and interquartile range of total SRQR scores (maximum: 21). SRQR-reported items were summarized; overall proportion of reported items for each article was estimated. Bivariate analyses examined the association between study characteristics and SRQR tertile. Simple linear regression was performed to examine the relationship between year and SRQR score. Of the 2562 titles/abstracts screened, 26 studies were included. The most common topics were hypospadias and congenital adrenal hyperplasia (Summary Figure). The median total score was 18.0 of 21 possible items (interquartile range: 3). All studies reported an abstract, problem formulation, purpose/context of the study, data collection methods, integration with prior work, limitations, and ethics review board approval. Most (25/26; 96.2%) reported sampling strategy, data analysis, synthesis/interpretation of findings and links to empirical data. Less fulfilled items included: a title identifying the study as qualitative (11/26, 42.3%), qualitative approach & research paradigm (11/26, 42.3%) and researcher characteristics & reflexivity (9/26, 34.6%). There was no association between study characteristics and SRQR score. There was a statistically significant increase in the SRQR score during the study period (β=1.0, p<0.0001). Studies fulfilled most SRQR checklist items. There was significant improvement in quality during the study period. Limitations include possible recency bias and exclusion of articles due to inconsistent categorizations in Pub Med. The quality and trajectory of qualitative study reporting in pediatric urology is encouraging. SRQR standards should be implemented by journals to continue improving the robustness and transparency of future qualitative manuscripts in pediatric urology.

A rapid ABO and RhD test demonstrates high fidelity to blood bank testing for RhD typing.

The rapid provision of blood products is life-saving for patients with massive hemorrhage. Ideally, RhD-negative blood products would be supplied to a woman of childbearing potential whose Rh type is unknown due to the risk of D-alloimmunization and the potential for hemolytic disease of the fetus and newborn to occur if RhD-positive blood products are transfused. Therefore, there is a need for a test that rapidly determines her RhD type. This study compared the RhD type determined using a rapid ABO and RhD test to the RhD type determined by an immunohematology reference laboratory. After receiving ethics review board approval, 200 random, unique, deidentified patient samples that had undergone routine pretransfusion testing in an immunohematology reference laboratory using column agglutination technology were collected and tested using a rapid ABO and RhD test (Eldoncard Home kit 2511). The RhD typing results from these two methods were compared to determine the accuracy of the rapid ABO and RhD test. The rapid ABO and RhD test produced results that were concordant with the transfusion service's results in 199/200 (99.5%) of cases, with a negative predictive value of 98.2% and 99.3% sensitivity. The single outlier was likely an RhD variant due to its serological characteristics. These data indicate that this rapid ABO and RhD test could be used for the rapid determination of a patient's RhD type, perhaps even in the emergency department, which could guide the selection of blood products provided during their resuscitation.

The Characteristics of female students in Allied Health Sciences Institution who performed routine breast self-examination (BSE) in Indonesia and Pakistan

Breast cancer is a major public health concern worldwide. The incidence of breast cancer remains high. The mortality rate and prognosis for breast cancer can be improved with early diagnosis and therapy. Self-examination of the breasts is a common method of early diagnosis for women's health issues. This study aimed to explore the characteristics of female students in Allied Health Sciences Institution who performed regular breast self-examination in Indonesia and Pakistan. After institutional ethics review board approval and informed consent, a quantitative survey recruited 430 female students from Allied Health Sciences institutions in Indonesia and Pakistan. This study strictly followed the highest level of ethical standards proposed by Helsinki Declaration (Revised 2013). A closed and open-ended questionnaire was used to collect data on their demographics and characteristics. The questionnaire was distributed online using a google form. Data were analyzed using descriptive analytics . The findings of this study showed that n=395(91.86%) were aged 18-35 years, and 51% were from rural. 49% from urban areas. The majority of participants were single or never married (88%). Most participants were undergraduate students (95.35%). Almost half participants did routine BSE once a month (48.6%). Only 16% were very confident about doing a breast self-examination. Nearly half respondents had never seen a doctor (47%). A positive attitude was seen among all the students. Additionally, most students performed a weekly breast examination. Evidently, more than half of the participants lacked self-assurance when it came to performing a breast assessment. We found a significant percentage who had never been to a doctor for medical attention. Public campaigns to raise awareness and urge female student in allied health science to regularly see their doctors and engage in BSE are so crucial

Outcomes of Conservative Management in a Clinically Stable Patient with Traumatic Liver Injury

Objective: The purpose of this research was to examine the success of non-surgical therapy for patients in stable condition who had come with serious liver injuries to the emergency department of a public tertiary care hospital in Karachi, Pakistan. Method: This retrospective research was carried out between February 2022 to August 2022 in department of General Surgery, Civil Hospital Ruth Pfau, DUHS, Karachi, after the ethical approval of the institute ethical review board. Patients were divided into two groups, group I receiving conservative care and group II undergoing surgery. Demographics, injury categorization, related lesions, surgical therapy, morbidity, mortality, and length of hospital stay were all were recorded through a questionnaire. Results: The average age of the 200 participants in the present research was 39.15± 10.47 years. There were 133 (66.5%) males who sustained injuries. The majority of patients (n=150, 75%) were found to have only mild liver damage (grades I–III), whereas 50 patients (25%) had more severe liver damage (grades IV–V). 150 patients (75%) were treated with conservative (NOM) care, whereas 50 patients (25%) had surgical intervention. Twenty-one deaths (10.5 %) were recorded in total. Conclusion: Conservative care is the preferred course of action for patients with stable hemodynamics, whereas surgical intervention is the treatment of choice for those with hemodynamic instability. Patients undergoing conservative treatment should be closely monitored. Mortality and morbidity rates were not significantly higher in patients whose conservative therapy failed.

"Expectations and Perceptions of Medical Students From a 4-Week Research Module: A Longitudinal Cohort Survey".

Clinical decision-making revolves around evidence-based medicine. Evidence-based medicine entails research problems, their evaluation against available scientific literature and implementing the results into practice. Medical undergraduates lack experience in the research process. This study aimed to analyze the difference between the precourse expectations and postcourse perception of students after an interventive, mandatory research module. This longitudinal cohort survey was conducted at Azad Jammu Kashmir Medical College, Muzaffarabad. Fourth-year medical students were included in this study. After ethical review board approval, online survey questionnaires were circulated at 2 data points: before starting the research module and after it ended. Data were analyzed and nonparametric Mann-Whitney U test and Wilcoxon tests were applied to compare the difference in responses, regarding expectation and perception of the research module. Total participants were 104; the response rate was 100% for the expectation questionnaire, whereas it dropped to 77% for the perception questionnaire. Female students had a higher response rate. In comparison of the 2 questionnaires, a statistically significant difference was observed in the student's ability to conduct literature search and critical literature appraisal (P = .000 and .00, respectively). There was also a perceived improvement in scientific writing, problem-solving abilities, and communication skills. Overall, a significant difference was found between the expectation and perception of students. Students had high expectations from the research module. After the course, their perception of their own communication skills, research abilities, scientific writing, and research aptitude has significantly improved.

Living systematic review and meta-analysis of the prostate MRI diagnostic test with Prostate Imaging Reporting and Data System (PI-RADS) assessment for the detection of prostate cancer: study protocol

IntroductionThe Prostate Imaging Reporting and Data System (PI-RADS) standardises reporting of prostate MRI for the detection of clinically significant prostate cancer. We provide the protocol of a planned living systematic...

A Digital Peer Support Platform to Translate Web-Based Peer Support for Emerging Adult Mental Well-being: Protocol for a Randomized Controlled Trial

BackgroundMental health issues among emerging adults (aged 19-25 years) on a global scale have underscored the need to address their widespread experiences of depression and anxiety. As a result of the COVID-19 pandemic, emerging studies are being directed toward the development and deployment of digital peer emotional disclosure and support for the psychological well-being of emerging adults. However, it is important to explore the implementation and clinical effectiveness, as well as associated mechanisms of change, for optimal approaches in conducting digital peer support interventions for emerging adults’ psychological well-being.ObjectiveWe describe a randomized controlled trial to evaluate the implementation and clinical effectiveness of Acceset, a digital peer support intervention to address emerging adult mental well-being. The intervention has 2 components. First, the digital peer support training equips befrienders (ie, peers who provide support) to harness 4 components of psychological well-being—mattering, selfhood, compassion, and mindfulness—to provide effective peer support for seekers (ie, peers who seek support). Second, Acceset incorporates psychological well-being digital markers and harnesses community engagement to drive emotional disclosure among peers.MethodsA total of 100 participants (aged 19-25 years) from the National University of Singapore will be recruited and randomized into 2 arms. In arm 1 (n=50), the seekers will use Acceset with befrienders (n=30) as well as moderators (n=30) for 3 weeks. Arm 2 comprises a wait-listed control group (n=50). A questionnaire battery will be used to monitor seekers and befrienders at 4 time points. These include baseline (before the intervention), 3 weeks (end of the intervention), and 6 and 9 weeks (carryover effect measurement). Implementation outcomes of the intervention will involve evaluation of the training curriculum with respect to adoption and fidelity as well as user acceptability of the Acceset platform and its feasibility for broader deployment. Clinical outcomes will include mattering, selfhood, compassion, mindfulness, perceived social support, and psychological well-being scores.ResultsThis protocol received National University of Singapore Institutional Ethics Review Board approval in October 2021. Recruitment will commence in January 2022. We expect data collection and analyses to be completed in June 2022. Preliminary findings are expected to be published in December 2022. The Cohen d index will be used for effect size estimation with a .05 (95% reliability) significance level and 80% power.ConclusionsThis protocol considers a novel digital peer support intervention—Acceset—that incorporates components and digital markers of emerging adult mental well-being. Through the validation of the Acceset intervention, this study defines the parameters and conditions for digital peer support interventions for emerging adults.Trial RegistrationClinicalTrials.gov NCT05083676; https://clinicaltrials.gov/ct2/show/NCT05083676International Registered Report Identifier (IRRID)PRR1-10.2196/34602

Sonographic Findings in patients of Hepatitis B &amp; C

Background: Role of Ultrasound into Acute Viral Hepatitis is inadequate for excluding jaundice surgical reasons. Though, here are definite features of ultrasound that may assist us for expect acute viral hepatitis in preliminary only some days previous to clinical jaundice onset. Aim: To determine the sonographic findings in patients of Hepatitis B and Hepatitis C. Methodology: A descriptive study was conducted at The university of Lahore Teaching Hospital Lahore after Ethical Review Board approval at university of Lahore faculty of Allied Health sciences, Lahore. On the basis of diagnosis inclusion criteria were included adult patients of both genders for abdominal ultrasound. And patients who are willing to participate. In exclusion Criteria excluded the Patient present with any known pathologies. Collection of data was done by the help of convenient technique of sampling according to gender, age as well as sonographic findings of patients with acute viral hepatitis B &amp; C. Results: Out of total number of 162 patients, 129(79%) were males and 33(20%) were females, 94(58%) patients had fever and 68(42%) had no fever. Out of total number of 162 patients, 57(35%) patients had positive Hepatitis B, 105(64%) had negative, 73(45%) patients had positive Hepatitis C, 89(54%) had negative, 67(41%) patients alter liver parenchymal echotexture, 68(42%) had coarse liver echotexture and 27 (16%) had normal homogenous echotexture. 63(38%) patients had irregular margins of liver and 99(61%) had regular margins of liver. 63(39%) had chronic liver disease, 25(15%) had hepatomegaly and 74(45%) had normal size. Conclusion: From our study, we concluded that cirrhosis of liver related with Hepatitis B and Hepatitis C virus more ordinary within man than woman. Cirrhosis of liver related with Hepatitis B and Hepatitis C virus are majorly affect the rural areas. Keywords: Hepatitis B &amp; C, Ultrasonography, Chronic liver disease, Jaundice, liver parenchymal disease.

Prediction Aided Tapering In rheumatoid arthritis patients treated with biOlogicals (PATIO): protocol for a randomized controlled trial

BackgroundBiological disease-modifying anti-rheumatic drugs (bDMARDs) are effective in the treatment of rheumatoid arthritis (RA) but are expensive and increase the risk of infection. Therefore, in patients with a stable low level of disease activity or remission, tapering bDMARDs should be considered. Although tapering does not seem to affect long-term disease control, (short-lived) flares are frequent during the tapering process. We have previously developed and externally validated a dynamic flare prediction model for use as a decision aid during stepwise tapering of bDMARDs to reduce the risk of a flare during this process.MethodsIn this investigator-initiated, multicenter, open-label, randomized (1:1) controlled trial, we will assess the effect of incorporating flare risk predictions into a bDMARD tapering strategy. One hundred sixty RA patients treated with a bDMARD with stable low disease activity will be recruited. In the control group, the bDMARD will be tapered according to “disease activity guided dose optimization” (DGDO). In the intervention group, the bDMARD will be tapered according to a strategy that combines DGDO with the dynamic flare prediction model, where the next bDMARD tapering step is not taken in case of a high risk of flare. Patients will be randomized 1:1 to the control or intervention group. The primary outcome is the number of flares per patient (DAS28-CRP increase > 1.2, or DAS28-CRP increase > 0.6 with a current DAS28-CRP ≥ 2.9) during the 18-month follow-up period. Secondary outcomes include the number of patients with a major flare (flare duration ≥ 12 weeks), bDMARD dose reduction, adverse events, disease activity (DAS28-CRP) and patient-reported outcomes such as quality of life and functional disability. Health Care Utilization and Work Productivity will also be assessed.DiscussionThis will be the first clinical trial to evaluate the benefit of applying a dynamic flare prediction model as a decision aid during bDMARD tapering. Reducing the risk of flaring during tapering may enhance the safety and (cost)effectiveness of bDMARD treatment. Furthermore, this study pioneers the field of implementing predictive algorithms in clinical practice.Trial registrationDutch Trial Register number NL9798, registered 18 October 2021, https://www.trialregister.nl/trial/9798. The study has received ethical review board approval (number NL74537.041.20).

Attitude and Behavior of Maternal Health Care Providers During Child Birth in a Tertiary Care Hospital in Karachi

Background: Pakistan is among the most populous countries of South East Asia with very high maternal mortality rate. One of the reasons of this elevated maternal mortality is non-availability of skilled workers at the time of labour. Objective: The study was carried out to see the frequency of abuse and disrespect during childbirth at a public sector hospital of Karachi and whether it affects their choice regarding the place of delivery in future pregnancy or not? Methodology: A cross sectional study was done after ethical review board approval and consent. A prevalidated questionnaire was used to collect the data from 476 women after their delivery but before they get discharged from the heath facility. Descriptive statistics were calculated and Univariate and multivariate analysis was done using spss 25. Result: Out of 466 patients, 401 (86%) reported some kind of disrespect and abuse from health care providers. Around 60% responded that they were not introduced to the health provider while 30% complained regarding the lack of involvement during and before the procedure. Almost 25% participants complained that no barrier was used to cover them during the procedure. Conclusion: Given study revealed that the occurrence of non-dignified maternity care is frequent in the area studied. Hospital administration and health policy makers should make sure and reinforce the training of health personnel who exhibit non dignified behavior towards laboring woman. This will help in reducing the maternal humiliation and psychological trauma of vulnerable women in public sector hospitals. Moreover maternal health will also improve as more women will attend health care facility for labour and delivery. Keywords: Disrespect, Abuse, Respectful maternity care, Facility delivery, maternal health

The frequency and Risk Factors of Re-amputation in Diabetic Foot Disease at a tertiary care hospital.

Introduction: The prevalence of diabetes in Pakistan is 11.7% and the preva-lence of diabetic foot in Pakistan is 13.9% with amputation rate of as high as 48%. Re-amputation carries significant morbidity in form of economic im-pact. Like most re-operations, it reflects failure of previous surgery and thus translates into wastage of resources.Objective: To determine the frequency and associated risk factors of re-amputation, in patients who undergo amputation secondary to diabetic foot syndrome in our population.Methodology: This study was conducted at the Department of Surgery De-partment of Surgery, and Diabetic Clinic Ruth Pfau Civil Hospital Karachi, from August 2020 to July 2021, after approval of ethical review board. We enrolled a total of 125 patients in our study. Data was entered and analyzed using SPSS version 22.0. Mean ±SD/ Median (IQR) was computed for age, HbA1C, duration of diabetes, duration of symptoms leading to amputation, ulcer size, ankle-brachial index and duration of re-amputation. Frequency and percentage were computed for all the categorical variables like gender, co-morbid, type of diabetes, diabetic neuropathy, morphology of diabetic foot ulcer, indication of amputation, peripheral arterial disease, level of am-putation, indication of re-amputation, and level of re-amputation.Result: Among enrolled 125 patients, 85 patients (68%) were male and 40 patients (32%) were females. Mean age was 48.75 ±9.702years. Mean dura-tion of diabetes was 11.12 ±6.64 years and mean HbA1C was 8.246 ±1.1357. During study period 61(48.8%) patients required re-amputation. Mean ABPI in patient requiring re amputation is 0.790 ±0.2501(p=0.000).Conclusion: Patients at risk of re-amputation may be identify by focusing upon good evaluation that includes assessing additional risk factors and deciding initial level of amputation. It is important to have enhance in-formed consent in avoiding the morbidity of additional surgery.Key words: Diabetic foot disease. Amputation, Re amputation.

77 INCONTINENCE AND DECONDITIONING IN A NONFRAIL SAMPLE OF INPATIENTS AT A UNIVERSITY TEACHING HOSPITAL

Abstract Background Incontinence occurs in 26% of hospitalised adults1. Deconditioning in hospitalised adults is common and contributes to increased hospital stay2. The #endpjparalysis movement motivates us to reduce harms of hospitalisation older adults. Methods We surveyed inpatients to capture the point prevalence of incontinence. We also collected information regarding functional status, continence status and use of continence wear. Local ethical review-board approval was obtained. All participants provided informed consent. Results There were 86 responses. Mean age of participants was 71.5 years. 45.4% were female, &amp;gt;95% were admitted from home and were functionally independent. Mean length of stay for respondents was 7.4 days ±12. The median Clinical Frailty Scale, for respondents aged &amp;gt;65 years, was 3, indicating this cohort is not frail. 17 respondents reported incontinence on the day of survey; 8 of these reported that incontinence was a new experience for them since their admission. 24 respondents wore incontinence wear at home, 31 were wearing incontinence wear on the day of survey. Of 80 respondents who could toilet independently at home, 23 (26%) reported a new dependency to toilet. Of 83 respondents who mobilised independently at home (with or without an aid), 11 reported needing assistance of one-person to walk, 3 needed the assistance of two-people to walk or stand, five people required a hoist, while 3 were bedbound on the day of survey. Conclusion We describe increased dependency in mobility, toileting and increased use of continence wear in non-frail hospitalised older adults. Future work is needed to maintain function during admission to hospital.

Outcome of fecal incontinence in the two-staged seton fistulotomy for complex fistula in ANO.

Objective: To determine the frequency of fecal incontinence in the two-staged Seton fistulotomy in complex fistula in ano. Study Design: Prospective Cohort study. Setting: Surgical Out-patient Department at Shaikh Zayed Hospital Lahore. Period: September 2015 till March 2016. Material &amp; Methods: After ethical review board approval, data was collected from 100 patients who fulfilled the inclusion criteria. All the procedures were conducted in the lithotomy position, under spinal or general anesthesia. A rigid sigmoidoscopy and proctoscopy was done prior to intervention. Fistula tract was marked using hydrogen peroxide (H202) for the identification of the internal opening. The external opening was gently probed using a standard 3 mm blunt-tipped probe till the internal opening was reached. The portion of the track outside the sphincter mechanism and any lateral tracts were laid open. A feeding tube of size 5 French was loosely tied around the remaining muscular portion of the sphincter complex. The seton was left in place for six weeks followed by secondary fistulotomy. Patients were evaluated for incontinence one month after the second procedure. Results: In our study, mean age was calculated as 47.38+10.96 years, 73%(n=73) were male and 27%(n=27) were females, frequency of fecal incontinence in the two-staged Seton fistulotomy in complex fistula in ano was recorded in 17%(n=17). Conclusion: The frequency of fecal incontinence in the two-staged seton fistulotomy for complex fistula in ano was acceptable in our study population and in tandem with literature. The procedure may be a suitable alternative to loose-seton placement alone.

Atrial Natriuretic Peptide in the Prevention of Postoperative Acute Renal Dysfunction in Patients Undergoing Heart Transplantation - An Investigator-Driven, Single-Center, Blinded, Randomized and Placebo-Controlled Trial

Purpose The development of acute kidney injury (AKI) and renal dysfunction is a common complication after heart transplantation (HTx) that is associated with increased morbidity and mortality. When used for treatment of AKI, infusion of atrial natriuretic peptide (ANP) has been shown to increase renal blood flow and glomerular filtration rate (GFR) after complicated cardiac surgery and in cyclosporine-induced AKI after HTx. Furthermore, it was shown that ANP reduced the probability of dialysis in cardiac surgery-associated AKI. The aim of this investigation was to evaluate whether ANP infusion could prevent or mitigate acute renal dysfunction after HTx. Methods After approval of Ethical Review Board and the Swedish Medical Products Agency, 72 adult patients undergoing HTx were included after informed consent. The patients were randomized to receive either ANP or placebo (saline) by a web-based computerized random-number generator. The anesthesia/intensive staff and physicians were blinded to the allocated treatment throughout the entire study. After induction of anesthesia, a continuous intravenous infusion of either ANP (HANP1000®, Daichii Sankyo Propharma, Japan) at a dose of 50 ng/kg/min or the equivalent volume of placebo (saline) was started. The administration of the study drugs continued for five postop days, or until the patient died or treatment with dialysis was started. Inclusion has been completed. Endpoints The primary end-point was measured mGFR at day five. mGFR was assessed by the infusion clearance of 52Cr-EDTA. The difference in mGFR between groups was estimated using intention-to-treat and per-protocol analyses. To detect a 30% higher mGFR in the ANP group, 31 patients per group would be required, assuming a 80% power and a two-sided error of 0.05. To compensate for drop-outs and for the use of nonparametric tests, we included 35 randomised patients per group. Secondary end-points were: the incidence of postoperative AKI (KDIGO criteria), daily postoperative serum creatinine, need for dialysis, intra- and postoperative diuresis, the use of diuretics, length of ICU and hospital stay, ICU mortality and 30-days mortality, length of mechanical ventilation, incidence of hypotension and arrhythmias and inotropic score.

Risk of Inflammatory Bowel Disease in HIV Patients: A Danish Cohort Study (1983-2018) with American Validation (1999-2018)

Background: HIV infection is implicated in the development of several immune mediated disorders, but the risk of inflammatory bowel disease (IBD) in people living with HIV (PLWH) remains uncertain. We aimed to study the risk of IBD among PLWH in a nationwide population-based Danish cohort study and to validate our findings with a US insurance-based database. Methods: Using Danish national patient registers (1983-2018), we identified a cohort of 8,995 PLWH who were matched to 449,750 HIV-negative individuals by age and sex, and followed for 7,154,999 person-years. Cumulative incidence of IBD in PLWH compared with matched non-HIV individuals was calculated. Cox regression analysis was used to estimate hazard ratios (HR) with 95% confidence intervals (CI) for development of IBD. Findings were validated using a US insurance-based cohort, Explorys (1999-2018), with results reported as odds ratios (OR) with 95% CI. Findings: The risk of IBD was significantly increased among PLWH in Denmark (HR: 2.24, 95% CI: 1.78-2.82) compared with the matched non-HIV population. This was seen for both Crohn’s disease (HR: 2.18, 95% CI: 1.43-3.34) and ulcerative colitis (HR: 2.22, 95% CI: 1.68-2.92) and in both the pre- and post-HAART era (pre-1996 HR: 2.30, 95% CI: 1.55-3.42; 1996-onwards HR: 2.11, 95% CI: 1.59-2.80). Risk was also increased in male (HR: 2.75, 95% CI: 2.15-3.52) but not female Danish PLWH (HR: 0.93, 95% CI: 0.48-1.79). US cohort analysis confirmed an increased risk of IBD in PLWH compared with non-HIV individuals (OR: 1.41, 95% CI: 1.35-1.49). Interpretation: This study finds a significantly increased risk of IBD among PLWH in both a Danish and US population. Further research into the interplay between HIV, IBD, and the impact of antiretroviral therapy on this relationship is required. Funding Statement: PSD is supported by the American Gastroenterology Association Research Scholar Award alongside Digestive Diseases Research Center grant and National Institue of Health grant (DK120515). Declaration of Interests: All authors declare that they have no conflict of interest. Ethics Approval Statement: TJ currently holds approval from the Danish Data Protection Agency for projects with datasets extracted from Danish national registers. Use of Explorys data does not require ethical review board approval. Ethical approval is not required for register-based research in Denmark.