Retraction: Lipoma Growing on the Back for 26 Years: A Bizarre Case Report.

[This retracts the article DOI: 10.7759/cureus.56999.].

Lipoma Growing on the Back for 26 Years: A Bizarre Case Report.

Lipoma is one of the most typical and benign tumors. They are typically regarded as a mass that is painless, asymptomatic, and slow-growing. It is composed of fat cells of the adult type. It can occur anywhere in the body and is often called a "universal" or ubiquitous tumor. They can develop in any region containing adipose tissue, with a higher prevalence in the subcutaneous tissue of the trunk and the nape of the neck and the limbs and occasionally in other locations, including the hand. There are three main varieties: encapsulated, diffuse, and multiple lipomas. A few lipomas may contain other tissues: fibrolipoma, neurolemma, and myelolipoma. Lipoma, when present for a long time, may undergo certain changes. This is particularly true in cases of lipoma under subcutaneous tissues of the thigh, buttock, or retroperitoneal lipoma. Such changes can be malignant, sarcomatous, calcification, or saponification. Clinically, a lipoma can occur in different anatomical situations; according to this, a lipoma can be classified into subcutaneous type, subfascial type, intramuscular type, subserous type, submucous type, intra-articular type, or it can be intraglandular. Lipomas, the most prevalent benign mesenchymal tumors, consist of mature lipocytes. Typically, lipomas are small, weighing only a few grams, with a maximum diameter usually under 2 cm. The term "giant" is applied when a lipoma reaches a diameter of at least 10 cm or weighs a minimum of 1,000 g. Due to their substantial size, giant lipomas can lead to functional limitations, such as lymphedema, pain syndromes, or nerve compression. Given the unique nature of this condition, characterized by the considerable size of the lesion and the challenges in both diagnosis and treatment, we present a case involving a 45-year-old woman with a giant lipoma in the suprascapular region.

The Miraculous Diagnostic Role of Indocyanine Green in a Diabetic Foot Ulcer: A Rare Case Report.

Diabetes is a chronic metabolic disorder characterized by elevated levels of glucose in the blood. This causes small nerve polyneuropathy resulting in diabetic foot ulcers. A diabetic foot ulcer is an open sore or wound that develops as a result of chronic diabetes. Indocyanine green angiography (ICGA) near-infrared (NIR) can provide real-time visualization of blood flow within the microvasculature of the underlying organ. Here, we discuss a 63-year-old patient who came with a diabetic foot ulcer over his right great toe. His blood glucose level was 208 mg/dl. He drinks alcohol occasionally and smokes regularly. The tissue perfusion of his right foot was checked using the indocyanine green dye, after which orthopedic surgeons were consulted, and the gangrenous part was amputated.

The Wonder Dye: Uses and Implications of Indigocyanine Green in Various Surgeries.

Indigocyanine green (ICG) is a fluorophore dye that has been extensively used in recent modern times for bioimaging in numerous surgeries to aid in easier identification of occult and often tricky-to-find anatomical structures. Surgery becomes complex and challenging due to multiple anatomical anomalies, pathological fibrosis, obesity, or previous surgeries. To overcome these obstacles in surgery, the surgeon yearns to know the structures present beyond their white light vision so that while dissecting the organ, they can avoid injuring the critical systems in the vicinity of dissection. Near-infrared (NIR) imaging aids in visualising the tissues at depth/in the area of dissection, thereby preventing any possible surgical catastrophes due to them inadvertently damaging surrounding vital structures. Various advantages in surgeries like gastric sleeve surgery, lymph node and tumour detection, localisation of ureters and biliary tracts, and intraoperative tissue perfusion of flaps have been described in this study. This review article aims to compile a short list of utilities of ICG with NIR imaging in various surgical interventions. The merits and demerits of this imaging technique have been noted. The study points out the uses of ICG fluorescence imaging under different surgical fronts. This review article concludes by comparing the results of studies performed by various authors. Results have been compared to conventional surgical modalities.

Efficacy of near-infrared fluorescence cholangiography using indocyanine green in laparoscopic cholecystectomy: A retrospective study.

Context: While laparoscopy has been the standard procedure for gallstone treatment, recent advances including the use of indocyanine green (ICG) in laparoscopic cholecystectomy have made it easier to understand the biliary tree and reduce the risk of bile duct injury. Aims: In this retrospective study, we aim to determine the efficacy of ICG in near-infrared fluorescence cholangiography (NIRFC) for visualising biliary anatomy. Settings and Design: A total of 90 patients with the symptoms of cholelithiasis were enrolled for this retrospective study. Subjects and Methods: All the patients underwent cholecystectomy approximately 53.8 min (40-90 min) after the intravenous administration of mean volume 1.6 ml (1-2 ml) ICG. The surgeons used NIRFC along with ICG for real-time visualisation of biliary anatomy. Results: The mean operative time for the surgery was 65.7 min (25-120 min) with no post-surgical complications observed in the patients. The average length of stay was 2 days (1-3 days). ICG usage with NIRFC enabled identification of cystic duct, common hepatic and common bile duct, the junction between common hepatic and bile duct, right and left hepatic duct in 87.7%, 94.4%, 80% and 14.4% of cases, respectively. Conclusions: ICG fluorescence allowed successful visualisation of at least 1 biliary structure in 100% of cases.

Phase III randomized clinical trial of BV-4051, an Ayurvedic polyherbal formulation in moderate SARS-CoV-2 infections and its impact on inflammatory biomarkers.

SARS-CoV-2 virus and its variants continue to be a challenge inspite of widespread vaccination and preventive measures. We hypothesized an oral, safe polyherbal formulation with antiinflammatory properties may improve the clinical outcome of this disease. BV-4051, a formulation from four Ayurvedic plants namely Ashwagandha, Boswellia, Ginger and Turmeric was used for the treatment of hospitalized moderate COVID-19 patients along with standard of care (SOC). Patients were randomly assigned to receive BV-4051 or placebo tablets for 14 days, at four sites in India during late 2020 to early 2021. Among 208 randomized subjects, 175 completed the study. In BV-4051 group the mean reduction in duration of illness (p = 0.036), alleviation and severity scores of several symptoms like fever, cough, smell, and taste disorders were statistically significant (p ≤ 0.05). A sub-set analysis of subjects treated with or without Remdesivir as SOC showed mean reduction in duration of illness in BV-4051 (p = 0.030), and severity scores (p ≤ 0.05). Mean difference in Interleukin-6 was statistically significant (p = 0.042) on BV-4051 without Remdesivir. BV-4051 may reduce duration of illness, symptoms severity, Interleukin-6, and prevent the incidence of COVID-19 complications. It may have an adjunctive effect with other SOC. Larger extensive clinical testing may give a better understanding of its effect.

Limy Bile Syndrome: A Report of a Rare Case.

Milk of Calcium Bile or Limy Bile Syndrome (LBS) is a sporadic and infrequent complication of cholecystitis in which the gallbladder is filled with radio-opaque, abnormal bile secretion. A 40-year-old female came to a tertiary care hospital with symptoms of recurrent pain upper abdomen for two years. On examination, the patient had mild jaundice and mild tenderness at Murphy's point exacerbated on deep inspiration. Laboratory investigations suggested raised levels of bilirubin and hepatic enzymes. Upper GI endoscopy revealed a normal GI tract. A hepatobiliary iminodiacetic acid-cholecystokinin (HIDA-CCK) scan suggested a gallbladder ejection fraction of 5%. Cholecystectomy was done the next day. Infrared imaging under Indocyanine green (ICG) dye revealed a completely dark gallbladder. The patient was asked to take ursodeoxycholic acid preparation post-operatively for four weeks. This case of LBS was discharged on the third postoperative day. She was asked to regularly follow up with the surgeons. LBS is a rare patho-clinical entity with a need for standardized diagnostic and treatment regimen. Further case reporting and studies are required to understand the disease in more depth.

Intra-operative enteroscopic polypectomy-An innovative hybrid approach using straight sticks.

BACKGROUND: Peutz-Jeghers Syndrome (PJS) is an uncommon intestinal polyposis disorder. Bowel obstructions are a recurring problem in PJS and as many as 50% of these patients require surgery. The current standard of care for these patients is to perform a flexible enteroscopic polypectomy. The traditional push-pull enteroscopy however, might be unavailable or unsuitable in an emergency setting. Alternatively, repeated laparotomies with multiple small bowel resections can lead to short bowel syndrome. METHODS: In our series, we describe an innovative technique where a short midline laparotomy permitted sufficient access to reduce the intussusception(s) and perform a bowel walk. Rigid laparoscopic instruments were introduced within the small bowel lumen via enterotomies, to perform polypectomies along the entire small bowel length. This precludes the need for small bowel resections which can thwart the development of short bowel syndrome. RESULTS: Two patients with PJS presenting with acute small bowel obstruction underwent surgery using the described approach. Another two patients with PJS having multiple intussusceptions on CT underwent an elective prophylactic polypectomy using the same approach. We were able to run the bowel in its entirety and a maximum of 41 polyps were retrieved from the port site enterotomy. The operating times were modest and no unique complications pertaining to this technique were encountered. CONCLUSION: Small bowel polypectomy using rigid instrumentation employing a limited midline laparotomy is an attractive option for both emergency and elective settings in patients with PJS.

A Multicentric, Randomized, Controlled Phase III Study of Centhaquine (Lyfaquin®) as a Resuscitative Agent in Hypovolemic Shock Patients.

INTRODUCTION: Centhaquine (Lyfaquin®) showed significant safety and efficacy in preclinical and clinical phase I and II studies. METHODS: A prospective, multicentric, randomized phase III study was conducted in patients with hypovolemic shock, systolic blood pressure (SBP) ≤ 90 mmHg, and blood lactate levels ≥ 2 mmol/L. Patients were randomized in a 2:1 ratio to the centhaquine group (n = 71) or the control (saline) group (n = 34). Every patient received standard of care (SOC) and was followed for 28 days. The study drug (normal saline or centhaquine 0.01 mg/kg) was administered in 100 mL of normal saline infusion over 1 h. The primary objectives were to determine changes (mean through 48 h) in SBP, diastolic blood pressure (DBP), blood lactate levels, and base deficit. The secondary objectives included the amount of fluids, blood products, and vasopressors administered in the first 48 h, duration of hospital stay, time in intensive care units, time on ventilator support, change in acute respiratory distress syndrome (ARDS), multiple organ dysfunction syndrome (MODS), and the proportion of patients with 28-day all-cause mortality. RESULTS: The demographics of patients and baseline vitals in both groups were comparable. The cause of hypovolemic shock was trauma in 29.4 and 47.1% of control group and centhaquine group patients, respectively, and gastroenteritis in 44.1 and 29.4%, respectively. Shock index (SI) and quick sequential organ failure assessment at baseline were similar in the two groups. An equal amount of fluids and blood products were administered in both groups during the first 48 h of resuscitation. A lesser amount of vasopressors was needed in the first 48 h of resuscitation in the centhaquine group. An increase in SBP from baseline was consistently higher up to 48 h (12.9% increase in area under the curve from 0 to 48 h [AUC0-48]) in the centhaquine group than in the control group. A significant increase in pulse pressure (48.1% increase in AUC0-48) in the centhaquine group compared with the control group suggests improved stroke volume due to centhaquine. The SI was significantly lower in the centhaquine group from 1 h (p = 0.032) to 4 h (p = 0.049) of resuscitation. Resuscitation with centhaquine resulted in a significantly greater number of patients with improved blood lactate (control 46.9%; centhaquine 69.3%; p = 0.03) and the base deficit (control 43.7%; centhaquine 69.8%; p = 0.01) than in the control group. ARDS and MODS improved with centhaquine, and an 8.8% absolute reduction in 28-day all-cause mortality was observed in the centhaquine group. CONCLUSION: Centhaquine is an efficacious resuscitative agent for treating hypovolemic shock. The efficacy of centhaquine in distributive shock is being explored. TRIAL REGISTRATION: Clinical Trials Registry, India; ctri.icmr.org.in, CTRI/2019/01/017196; clinicaltrials.gov, NCT04045327.

Resuscitative Effect of Centhaquine (Lyfaquin®) in Hypovolemic Shock Patients: A Randomized, Multicentric, Controlled Trial.

INTRODUCTION: Centhaquine (Lyfaquin®) showed significant efficacy as a resuscitative agent in animal models of haemorrhagic shock. Its safety and tolerability were confirmed in healthy human volunteers. In this study, our primary objective was to determine the safety, and the secondary objective was to assess the efficacy of centhaquine in patients with hypovolemic shock. METHODS: A prospective, multicentre, randomized phase II study was conducted in male and female patients aged 18-70 years with hypovolemic shock having systolic BP ≤ 90 mmHg. Patients were randomized in a 1:1 ratio to either the control or centhaquine group. The control group received 100 ml of normal saline infusion over 1 h, while the centhaquine group received 0.01 mg/kg of centhaquine in 100 ml normal saline infusion over 1 h. Every patient received standard of care (SOC) and was followed for 28 days. RESULTS: Fifty patients were included, and 45 completed the trial: 22 in the control group and 23 in the centhaquine group. The demographics of patients in both groups were comparable. No adverse event related to centhaquine was recorded in the 28-day observation period. The baseline, Injury Scoring System score, haemoglobin, and haematocrit were similar in both groups. However, 91% of the patients in the centhaquine group needed major surgery, whereas only 68% in the control group (p = 0.0526). Twenty-eight-day all-cause mortality was 0/23 in the centhaquine group and 2/22 in the control group. The percent time in ICU and ventilator support was less in the centhaquine group than in the control group. The total amount of vasopressors needed in the first 48 h of resuscitation was lower in the centhaquine group than in the control group (3.12 ± 2.18 vs. 9.39 ± 4.28 mg). An increase in systolic and diastolic BP from baseline through 48 h was more marked in the centhaquine group than in the control group. Compared with the control group, blood lactate level was lower by 1.75 ± 1.07 mmol/l in the centhaquine group on day 3 of resuscitation. Improvements in base deficit, multiple organ dysfunction syndrome (MODS) score and adult respiratory distress syndrome (ARDS) were greater in the centhaquine group than in the control group. CONCLUSION: When added to SOC, centhaquine is a well-tolerated and effective resuscitative agent. It improves the clinical outcome of patients with hypovolemic shock. TRIAL REGISTRATION: ClinicalTrials.gov identifier number: NCT04056065.

A multicentric, randomized, controlled phase III study of centhaquine (Lyfaquin ® ) as a resuscitative agent in hypovolemic shock patients.

INTRODUCTION: Centhaquine (Lyfaquin ® ) showed significant safety and efficacy in preclinical and clinical phase I and II studies. METHODS: A prospective, multicentric, randomized phase III study was conducted in patients with hypovolemic shock having systolic blood pressure (SBP) of ≤90 mm Hg and blood lactate levels of ≥2 mmol/L. Patients were randomized in a 2:1 ratio, 71 patients to the centhaquine group and 34 patients to the control (saline) group. Every patient received standard of care (SOC) and was followed for 28 days. The study drug (normal saline or centhaquine (0.01 mg/kg)) was administered in 100 mL of normal saline infusion over 1 hour. The primary objectives were to determine changes (mean through 48 hours) in SBP, diastolic blood pressure (DBP), blood lactate levels, and base deficit. The secondary objectives included the amount of fluids, blood products, vasopressors administered in the first 48 hours, duration of hospital stay, time in ICU, time on the ventilator support, change in patient's Acute Respiratory Distress Syndrome (ARDS), Multiple Organ Dysfunction Syndrome (MODS) scores, and the proportion of patients with 28-day all-cause mortality. RESULTS: The demographics of patients and baseline vitals in both groups were comparable. Trauma was the cause of hypovolemic shock in 29.41% of control and 47.06% of centhaquine, gastroenteritis in 44.12% of control, and 29.41% of centhaquine patients. An equal amount of fluids and blood products were administered in both groups during the first 48 hours of resuscitation. A lesser amount of vasopressors was needed in the first 48 hours of resuscitation in the centhaquine group. An increase in SBP from the baseline was consistently higher in the centhaquine group than in the control. A significant increase in pulse pressure in the centhaquine group than the control group suggests improved stroke volume due to centhaquine. The shock index was significantly lower in the centhaquine group than control from 1 hour (p=0.0320) till 4 hours (p=0.0494) of resuscitation. Resuscitation with centhaquine had a significantly greater number of patients with improved blood lactate and the base deficit than the control group. ARDS and MODS improved with centhaquine, and an 8.8% absolute reduction in 28-day all-cause mortality was observed in the centhaquine group. CONCLUSION: Centhaquine is a highly efficacious resuscitative agent for treating hypovolemic shock. The efficacy of centhaquine in distributive shock due to sepsis and COVID-19 is being explored. TRIAL REGISTRATION: Clinical Trials Registry, India; ctri.icmr.org.in, CTRI/2019/01/017196; clinicaltrials.gov, NCT04045327 . KEY SUMMARY POINTS: A multicentric, randomized, controlled trial was conducted to evaluate the efficacy of centhaquine in hypovolemic shock patients.One hundred and five patients were randomized 2:1 to receive centhaquine or saline. Centhaquine was administered at a dose of 0.01 mg/kg in 100 mL saline and infused over 1 hour. The control group received 100 mL of saline over a 1-hour infusion.Centhaquine improved blood pressure, shock index, reduced blood lactate levels, and improved base deficit. Acute Respiratory Distress Syndrome (ARDS) and Multiple Organ Dysfunction Syndrome (MODS) score improved with centhaquine.An 8.8% absolute reduction in 28-day all-cause mortality was observed in the centhaquine group. There were no drug-related adverse events in the study.

Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE): an international, randomised, placebo-controlled trial.

BACKGROUND: Myocardial injury after non-cardiac surgery (MINS) increases the risk of cardiovascular events and deaths, which anticoagulation therapy could prevent. Dabigatran prevents perioperative venous thromboembolism, but whether this drug can prevent a broader range of vascular complications in patients with MINS is unknown. The MANAGE trial assessed the potential of dabigatran to prevent major vascular complications among such patients. METHODS: In this international, randomised, placebo-controlled trial, we recruited patients from 84 hospitals in 19 countries. Eligible patients were aged at least 45 years, had undergone non-cardiac surgery, and were within 35 days of MINS. Patients were randomly assigned (1:1) to receive dabigatran 110 mg orally twice daily or matched placebo for a maximum of 2 years or until termination of the trial and, using a partial 2-by-2 factorial design, patients not taking a proton-pump inhibitor were also randomly assigned (1:1) to omeprazole 20 mg once daily, for which results will be reported elsewhere, or matched placebo to measure its effect on major upper gastrointestinal complications. Research personnel randomised patients through a central 24 h computerised randomisation system using block randomisation, stratified by centre. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary efficacy outcome was the occurrence of a major vascular complication, a composite of vascular mortality and non-fatal myocardial infarction, non-haemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism. The primary safety outcome was a composite of life-threatening, major, and critical organ bleeding. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01661101. FINDINGS: Between Jan 10, 2013, and July 17, 2017, we randomly assigned 1754 patients to receive dabigatran (n=877) or placebo (n=877); 556 patients were also randomised in the omeprazole partial factorial component. Study drug was permanently discontinued in 401 (46%) of 877 patients allocated to dabigatran and 380 (43%) of 877 patients allocated to placebo. The composite primary efficacy outcome occurred in fewer patients randomised to dabigatran than placebo (97 [11%] of 877 patients assigned to dabigatran vs 133 [15%] of 877 patients assigned to placebo; hazard ratio [HR] 0·72, 95% CI 0·55-0·93; p=0·0115). The primary safety composite outcome occurred in 29 patients (3%) randomised to dabigatran and 31 patients (4%) randomised to placebo (HR 0·92, 95% CI 0·55-1·53; p=0·76). INTERPRETATION: Among patients who had MINS, dabigatran 110 mg twice daily lowered the risk of major vascular complications, with no significant increase in major bleeding. Patients with MINS have a poor prognosis; dabigatran 110 mg twice daily has the potential to help many of the 8 million adults globally who have MINS to reduce their risk of a major vascular complication [corrected]. FUNDING: Boehringer Ingelheim and Canadian Institutes of Health Research.

Period-dependent Associations between Hypotension during and for Four Days after Noncardiac Surgery and a Composite of Myocardial Infarction and Death: A Substudy of the POISE-2 Trial.

BACKGROUND: The relative contributions of intraoperative and postoperative hypotension to perioperative morbidity remain unclear. We determined the association between hypotension and a composite of 30-day myocardial infarction and death over three periods: (1) intraoperative, (2) remaining day of surgery, and (3) during the initial four postoperative days. METHODS: This was a substudy of POISE-2, a 10,010-patient factorial-randomized trial of aspirin and clonidine for prevention of myocardial infarction. Clinically important hypotension was defined as systolic blood pressure less than 90 mmHg requiring treatment. Minutes of hypotension was the exposure variable intraoperatively and for the remaining day of surgery, whereas hypotension status was treated as binary variable for postoperative days 1 to 4. We estimated the average relative effect of hypotension across components of the composite using a distinct effect generalized estimating model, adjusting for hypotension during earlier periods. RESULTS: Among 9,765 patients, 42% experienced hypotension, 590 (6.0%) had an infarction, and 116 (1.2%) died within 30 days of surgery. Intraoperatively, the estimated average relative effect across myocardial infarction and mortality was 1.08 (98.3% CI, 1.03, 1.12; P < 0.001) per 10-min increase in hypotension duration. For the remaining day of surgery, the odds ratio was 1.03 (98.3% CI, 1.01, 1.05; P < 0.001) per 10-min increase in hypotension duration. The average relative effect odds ratio was 2.83 (98.3% CI, 1.26, 6.35; P = 0.002) in patients with hypotension during the subsequent four days of hospitalization. CONCLUSIONS: Clinically important hypotension-a potentially modifiable exposure-was significantly associated with a composite of myocardial infarction and death during each of three perioperative periods, even after adjustment for previous hypotension.