Representation and reporting of diverse groups in randomised controlled trials of pharmacological agents in inflammatory bowel disease: a systematic review.

Inflammatory bowel disease (IBD) is now recognised as a global disease, with incidence rapidly increasing in newly industrialised countries in South America, Asia, and Africa. Trials in IBD, therefore, should adequately represent diverse groups with respect to gender, age, place of residence, race, and ethnicity to ensure the global applicability and generalisability of their findings. In this systematic review, we searched PubMed and Embase for randomised controlled trials (RCTs) published in English from Jan 1, 1995, to Jan 13, 2023, evaluating the efficacy of any pharmacological intervention in patients with IBD. Of 7543 records yielded in the search, we included 617 records reporting data from 627 RCTs and 108 986 participants. The results show a paucity of adequate representation of diverse groups in these RCTs. This finding was true for various groups, including racially and ethnically diverse populations, older (aged >65 years) and younger (aged <18 years) populations, those who identify outside of the gender binary, and people from South America and Africa. Also, some regions had an apparent scarcity of funding sources for trials. Pharmaceutical companies and clinical trial organisations should aim to ensure adequate representation of such under-represented groups in future IBD trials.

Effect of Diabetes on the Male Reproductive System­A Histomorphological Study

Introduction Type 1 diabetes is an autoimmune disorder characterized by lack of insulin production by the ß cells of the pancreas. This lack of insulin causes a variety of systemic effects on the metabolism of the body, one of which is reproductive dysfunction. The present study investigates the effects of diabetes on the male reproductive system of streptozotocin (STZ)-induced diabetic rats. Material and Methods A total of 18 adult male Wistar rats weighing between 250 and 300 g were included in the present study. The animals were divided into normal and diabetic groups. The diabetic group was further subdivided into 2 subgroups with durations of 24 and 48 days. A single dose of STZ (40 mg/kg body weight) was administrated intraperitoneally to the animals of the diabetic group. After the planned duration, the testes and epididymides were dissected, and their gross weight was measured. The tissues were then processed for histological study. Results The gross weight of the testes and epididymides in diabetic rats at 24 and 48 days showed a decrease in comparison to the control. (p < 0.01 for testes and epididymides). Diabetic animals presented a significant decrease in the diameter of the seminiferous tubules compared with the control group (p < 0.01). The epididymides in the diabetic groups showed a considerable reduction in the tubular surface area compared with the control group (p < 0.01). There was also a reduction in the mean diameter, which was measured using the maximum and minimum diameter of the tubules (p < 0.01). Conclusion The present study is an insight into the adverse effects that diabetes can have on the tissue structure of the testes, of the epididymides, and ultimately on the process of spermatogenesis.

Transverse Sternal Split: a Safe Mini-invasive Approach for Perventricular Device Closure of Ventricular Septal Defect.

OBJECTIVE:: Perventricular device closure of ventricular septal defect through midline sternotomy avoids the cardiopulmonary bypass, however, lacks the cosmetic advantage. Perventricular device closure of ventricular septal defect with transverse split sternotomy was performed to add the cosmetic advantage of mini-invasive technique. METHODS:: Thirty-six pediatric patients with mean age 7.14±3.24 months and weight 5.00±0.88 kg were operated for perventricular device closure of ventricular septal defect through transverse split sternotomy in 4th intercostal space under transesophageal echocardiography guidance. In case of failure or complication, surgical closure of ventricular septal defect was performed through the same incision with cervical cannulation of common carotid artery and internal jugular vein for commencement of cardiopulmonary bypass. All the patients were postoperatively followed, and then discharged from hospital due to their surgical outcome, morbidity and mortality. RESULTS:: Procedure was successful in 35 patients. Two patients developed transient heart block. Surgical closure of ventricular septal defect was required in one patient. Mean duration of ventilation was 11.83±3.63 hours. Mean intensive care unit and hospital stay were 1.88±0.74 days and 6.58±1.38 days, respectively. There was no in-hospital mortality. A patient died one day after hospital discharge due to arrhythmia. No patients developed wound related, vascular or neurological complication. In a mean follow-up period of 23.3±18.45 months, all 35 patients were doing well without residual defect with regression of pulmonary artery hypertension as seen on transthoracic echocardiography. CONCLUSION:: Transverse split sternotomy incision is a safe and effective alternative to a median sternotomy for perventricular device closure of ventricular septal defect with combined advantage of better cosmetic outcomes and avoidance of cardiopulmonary bypass.

Transverse sternal split: a safe mini-invasive approach for perventricular device closure of ventricular septal defect

Abstract Objective: Perventricular device closure of ventricular septal defect through midline sternotomy avoids the cardiopulmonary bypass, however, lacks the cosmetic advantage. Perventricular device closure of ventricular septal defect with transverse split sternotomy was performed to add the cosmetic advantage of mini-invasive technique. Methods: Thirty-six pediatric patients with mean age 7.14±3.24 months and weight 5.00±0.88 kg were operated for perventricular device closure of ventricular septal defect through transverse split sternotomy in 4th intercostal space under transesophageal echocardiography guidance. In case of failure or complication, surgical closure of ventricular septal defect was performed through the same incision with cervical cannulation of common carotid artery and internal jugular vein for commencement of cardiopulmonary bypass. All the patients were postoperatively followed, and then discharged from hospital due to their surgical outcome, morbidity and mortality. Results: Procedure was successful in 35 patients. Two patients developed transient heart block. Surgical closure of ventricular septal defect was required in one patient. Mean duration of ventilation was 11.83±3.63 hours. Mean intensive care unit and hospital stay were 1.88±0.74 days and 6.58±1.38 days, respectively. There was no in-hospital mortality. A patient died one day after hospital discharge due to arrhythmia. No patients developed wound related, vascular or neurological complication. In a mean follow-up period of 23.3±18.45 months, all 35 patients were doing well without residual defect with regression of pulmonary artery hypertension as seen on transthoracic echocardiography. Conclusion: Transverse split sternotomy incision is a safe and effective alternative to a median sternotomy for perventricular device closure of ventricular septal defect with combined advantage of better cosmetic outcomes and avoidance of cardiopulmonary bypass.

Cervical Cannulation for Surgical Repair of Congenital Cardiac Defects in Infants and Small Children.

INTRODUCTION:: The biggest challenge faced in minimally invasive pediatric cardiac surgery is cannulation for cardiopulmonary bypass. Our technique and experience of cervical cannulation in infants and small children for repair of congenital cardiac defects is reported in this study. METHODS:: From January 2013 to June 2015, 37 children (22 males) with mean age of 17.97±8.63 months and weight of 8.06±1.59 kg were operated on for congenital cardiac defects through right lateral thoracotomy. The most common diagnosis was ventricular septal defect (18 patients). In all patients, right common carotid artery, right internal jugular vein and inferior vena cava were cannulated for institution of cardiopulmonary bypass and aorta was cross clamped through right 2nd intercostal space. RESULTS:: There were no deaths or any major complications related to cervical cannulation. Common carotid artery cannulation provided adequate arterial inflow while internal jugular vein with inferior vena cava provided adequate venous return in all patients. No patient required conversion to sternotomy or developed vascular, neurological or wound related complications. Three patients had residual lesions (small leak across ventricular septal defect patch-2, Grade II left atrio-ventricular valve regurgitation-1) and one patient had mild left ventricular dysfunction. At discharge, both common carotid artery and internal jugular vein were patent on color Doppler ultrasonography in all patients. In a mean follow-up period of 11.4±2.85 months, all patients were doing well. No patient had any wound related, neurological or vascular complication. No patient had residual leak across ventricular septal defect patch. CONCLUSION:: Cervical cannulation of common carotid artery and internal jugular vein is a safe, reliable, efficient and quick method for institution of cardiopulmonary bypass in minimally invasive pediatric cardiac surgery.

Cervical cannulation for surgical repair of congenital cardiac defects in infants and small children

Abstract INTRODUCTION: The biggest challenge faced in minimally invasive pediatric cardiac surgery is cannulation for cardiopulmonary bypass. Our technique and experience of cervical cannulation in infants and small children for repair of congenital cardiac defects is reported in this study. METHODS: From January 2013 to June 2015, 37 children (22 males) with mean age of 17.97±8.63 months and weight of 8.06±1.59 kg were operated on for congenital cardiac defects through right lateral thoracotomy. The most common diagnosis was ventricular septal defect (18 patients). In all patients, right common carotid artery, right internal jugular vein and inferior vena cava were cannulated for institution of cardiopulmonary bypass and aorta was cross clamped through right 2nd intercostal space. RESULTS: There were no deaths or any major complications related to cervical cannulation. Common carotid artery cannulation provided adequate arterial inflow while internal jugular vein with inferior vena cava provided adequate venous return in all patients. No patient required conversion to sternotomy or developed vascular, neurological or wound related complications. Three patients had residual lesions (small leak across ventricular septal defect patch-2, Grade II left atrio-ventricular valve regurgitation-1) and one patient had mild left ventricular dysfunction. At discharge, both common carotid artery and internal jugular vein were patent on color Doppler ultrasonography in all patients. In a mean follow-up period of 11.4±2.85 months, all patients were doing well. No patient had any wound related, neurological or vascular complication. No patient had residual leak across ventricular septal defect patch. CONCLUSION: Cervical cannulation of common carotid artery and internal jugular vein is a safe, reliable, efficient and quick method for institution of cardiopulmonary bypass in minimally invasive pediatric cardiac surgery.

A cadaveric study of the testicular artery and its clinical significance / Um estudo da artéria testicular em cadáveres e sua relevância clínica

Abstract Background Knowledge of testicular artery variations is vital to ensure that they are not neglected during a variety of different operative techniques, since damage can cause testicular atrophy. Objectives The present study was therefore intended to identify variants in the origin and course of the testicular arteries. An attempt was made to classify the arteries based on their various origins. Methods This study examined 42 formalin-fixed cadavers of 40 to 70-year-old adult males. Variant origins of the testicular artery were identified and classified. Variations in the origin and course of the artery were colored, photographed, and documented. The distances between the origins of the testicular arteries and the mid-points of the origins of the renal arteries were measured. Results Testicular arteries were classified into four categories on the basis of origin. This variability was defined in relation to the renal and inferior mesenteric arteries. The mean distance between the origin of the testicular artery and the mid-point of the origin of the renal artery were 3.08 and 3.47 cm, on the right and left sides respectively. Variations were almost exclusively found on the left side. The variations observed included multiple arterial twigs forming the testicular artery, suprarenal arteries arising from the testicular artery, and testicular artery duplication. Conclusion This study provides an insight into variations in the testicular artery and proposes a classification which could help surgeons during a variety of procedures on the male abdomen and pelvis.

Resumo Contexto O conhecimento de variações da artéria testicular é vital para assegurar que essas artérias não serão negligenciadas durante a realização de diferentes técnicas operatórias, já que qualquer dano poderia causar atrofia testicular. Objetivos Este estudo teve como objetivo identificar variações na origem e no trajeto das artérias testiculares. Foi feita uma tentativa de classificar as artérias com base em suas diferentes origens. Métodos Este estudo examinou 42 cadáveres de adultos do sexo masculino com idade entre 40 e 70 anos preservados em formol. As diferentes origens da artéria testicular foram identificadas e classificadas. Variações na origem e no trajeto da artérias foram coloridas, fotografadas e documentadas. Foram medidas as distâncias entre a origem das artérias testiculares e o ponto médio da origem das artérias renais. Resultados As artérias testiculares foram classificadas em quatro categorias com base em sua origem. Essa variabilidade foi definida com relação às artérias renal e mesentérica inferior. A distância média entre a origem da artéria testicular e o ponto médio da origem da artéria renal foi de 3,08 e 3,47 cm nos lados direito e esquerdo, respectivamente. As variações foram encontradas quase exclusivamente no lado esquerdo. As variações observadas incluíram múltiplos ramúsculos formando a artéria testicular, artérias suprarrenais surgindo a partir da artéria testicular, e duplicação da artéria testicular. Conclusão Este estudo traz informações sobre variações da artéria testicular e propõe uma classificação que poderia ajudar os cirurgiões durante diferentes procedimentos realizados no abdome e na pelve de pacientes do sexo masculino.

A cadaveric study of the testicular artery and its clinical significance.

BACKGROUND: Knowledge of testicular artery variations is vital to ensure that they are not neglected during a variety of different operative techniques, since damage can cause testicular atrophy. OBJECTIVES: The present study was therefore intended to identify variants in the origin and course of the testicular arteries. An attempt was made to classify the arteries based on their various origins. METHODS: This study examined 42 formalin-fixed cadavers of 40 to 70-year-old adult males. Variant origins of the testicular artery were identified and classified. Variations in the origin and course of the artery were colored, photographed, and documented. The distances between the origins of the testicular arteries and the mid-points of the origins of the renal arteries were measured. RESULTS: Testicular arteries were classified into four categories on the basis of origin. This variability was defined in relation to the renal and inferior mesenteric arteries. The mean distance between the origin of the testicular artery and the mid-point of the origin of the renal artery were 3.08 and 3.47 cm, on the right and left sides respectively. Variations were almost exclusively found on the left side. The variations observed included multiple arterial twigs forming the testicular artery, suprarenal arteries arising from the testicular artery, and testicular artery duplication. CONCLUSION: This study provides an insight into variations in the testicular artery and proposes a classification which could help surgeons during a variety of procedures on the male abdomen and pelvis.

CONTEXTO: O conhecimento de variações da artéria testicular é vital para assegurar que essas artérias não serão negligenciadas durante a realização de diferentes técnicas operatórias, já que qualquer dano poderia causar atrofia testicular. OBJETIVOS: Este estudo teve como objetivo identificar variações na origem e no trajeto das artérias testiculares. Foi feita uma tentativa de classificar as artérias com base em suas diferentes origens. MÉTODOS: Este estudo examinou 42 cadáveres de adultos do sexo masculino com idade entre 40 e 70 anos preservados em formol. As diferentes origens da artéria testicular foram identificadas e classificadas. Variações na origem e no trajeto da artérias foram coloridas, fotografadas e documentadas. Foram medidas as distâncias entre a origem das artérias testiculares e o ponto médio da origem das artérias renais. RESULTADOS: As artérias testiculares foram classificadas em quatro categorias com base em sua origem. Essa variabilidade foi definida com relação às artérias renal e mesentérica inferior. A distância média entre a origem da artéria testicular e o ponto médio da origem da artéria renal foi de 3,08 e 3,47 cm nos lados direito e esquerdo, respectivamente. As variações foram encontradas quase exclusivamente no lado esquerdo. As variações observadas incluíram múltiplos ramúsculos formando a artéria testicular, artérias suprarrenais surgindo a partir da artéria testicular, e duplicação da artéria testicular. CONCLUSÃO: Este estudo traz informações sobre variações da artéria testicular e propõe uma classificação que poderia ajudar os cirurgiões durante diferentes procedimentos realizados no abdome e na pelve de pacientes do sexo masculino.

Age and growth in the indian major carp Labeo rohita (Cypriniformes: Cyprinidae) from tropical rivers of Ganga basin, India.

Labeo rohita is a member of the Indian major carp species and originally an inhabitant of the Ganga river network in India. It is among the top ten aquaculture species of the world. Since there is a lack of information on the growth pattern of the wild populations of this species, this study aimed at evaluating the pattern of age and growth, to support the development of effective management plans. A total of 1082 samples of L. rohita were obtained from May 2009 to July 2012 in six drainages of the Ganga basin. Scales of the fish were used to determine the age and growth by analyzing the annual rings growth. Out of six populations, a maximum 8+ age classes were recorded from two rivers (Betwa and Sharda). The back-calculated lengths at 8+ age class ranged from 86.22 cm to 91.66 cm. However, for the rest of rivers up to 7+ age classes were recorded. Among growth parameters, specific rate of length increase (C(l)) and specific rate of weight increase (Cw) showed decreasing trend, and three distinct life stages of L. rohita were recorded based on growth constant data (C(lt)). Analysis of variance (ANOVA) of the back-calculated length data set of six populations indicated a significant difference (p < 0.05). All three populations showed significant variation in length attainment during 1+ and 3+ age groups, while two populations showed significant variation in length attainment during the 2+ and 7+ age classes. Additionally, analysis of age frequency at different length intervals indicated that with increase in age class, number of fish samples was reduced. Since the pattern of life history traits of L. rohita have not been attempted in the recent past; therefore, this study will guide fisheries biologists about the current stock structure of this fish across different spatial scale of the Ganga basin.