First-ever nasal spray for treating chronic rhinosinusitis without nasal polyps receives US FDA approval

USA: Fluticasone propionate nasal spray has received approval from the US Food and Drug Administration (FDA) as the first treatment of chronic rhinosinusitis without nasal polyps.

Chronic sinusitis (also called “chronic rhinosinusitis” or “CRS”) is one of the most common chronic diseases, affecting approximately 30 million adults in the United States. Research shows that the disease impairs quality of life to a similar degree as other serious chronic conditions, such as chronic obstructive pulmonary disease, sciatica, or migraine. Chronic sinusitis is also one of the most common diagnoses in adult outpatient medicine. Chronic sinusitis is diagnosed in approximately 10 million outpatient visits, of which approximately 70% result in antibiotic prescriptions, and leads to more than 600,000 surgeries annually. Although there are FDA-approved medications to treat nasal polyps, including XHANCE, no medication had ever been approved for the more than two-thirds of chronic sinusitis patients who do not have nasal polyps-until today.

“The FDA approval of XHANCE for the treatment of CRS without nasal polyps is an important milestone,” said Rick Chandra, M.D., Professor of Otolaryngology-Head and Neck Surgery, Endowed Director, Roland “Ron” Eavey, MD, SM Endowed Directorship in Leadership and Education, Service Chief, Rhinology and Skull Base Surgery, Vanderbilt University. “Until today, we have been forced to use unproven therapies to try and alleviate the symptoms that these patients suffer. While we often resort to using nasal steroid sprays in this patient population, they have never been shown to be effective in large placebo-controlled clinical studies. XHANCE, which uses the Exhalation Delivery System to enable delivery of an established topical steroid to the areas of the nasal cavity and sinuses we know to be extensively inflamed, is now proven to be effective in treating our CRS patients both with and without nasal polyps.”

“People who don’t suffer from chronic sinusitis may not appreciate how burdensome the condition can be. More than 80% of patients with chronic sinusitis report frustration with symptom relief when using a standard-delivery nasal steroid sprays, and patients commonly use multiple unproven over the counter medications in an effort to find symptom relief.” said Ramy Mahmoud, MD, MPH, CEO of Optinose. “Although chronic sinusitis is one of the most common diagnoses in outpatient physician visits, and surgery is available, there has never been a prescription medication approved by the FDA as safe and effective to treat the millions of patients without nasal polyps suffering from this debilitating disease. We are thrilled to now be able to offer new hope to these patients and believe XHANCE has the potential to become part of the standard of care for the treatment of chronic sinusitis.”

The approval was based on data from the ReOpen program evaluating XHANCE for treatment of adults with chronic sinusitis. A drug-device combination product, XHANCE uniquely combines a widely used nasal steroid with the Exhalation Delivery System™, an innovative delivery system designed to target the sites where inflammation occurs, especially difficult-to-access sinuses and sinonasal drainage tracts not typically reached by standard-delivery nasal sprays.

The safety profile and tolerability of XHANCE for patients in the ReOpen trials was generally consistent with its currently labeled safety profile. The most common adverse reactions (incidence ≥ 3%) in the ReOpen program were epistaxis, headache, and nasopharyngitis.

About XHANCE

XHANCE® is a drug-device combination product that uses the Exhalation Delivery System™ (also referred to as the EDS®) designed to deliver a topical steroid to the high and deep regions of the nasal cavity where sinuses ventilate and drain. XHANCE is approved by the U.S. Food and Drug Administration for the treatment of chronic rhinosinusitis (with and without nasal polyps) in patients 18 years of age or older.

About the ReOpen Program

The ReOpen program comprised two global, randomized, double-blind, placebo-controlled Phase 3 trials that evaluated the efficacy and safety of one or two sprays of XHANCE in each nostril twice daily, over 24 weeks, in patients suffering from chronic sinusitis. In ReOpen1, the first of the two trials, 332 chronic sinusitis patients either with or without concurrent nasal polyps were treated. In ReOpen2, 222 chronic sinusitis patients who did not have polyps in the nasal cavity were treated. The co-primary endpoints were change from baseline in symptoms, as measured by composite symptom score (nasal congestion, facial pain or pressure, and nasal discharge) at the end of week 4, and change in inflammation inside the sinus cavities, as measured by CT scans (change in the average of the percentages of volume occupied by disease in the ethmoid and maxillary sinuses) at week 24. The ReOpen trial program is a landmark research program that included the first ever large, placebo-controlled trials we are aware of to demonstrate that any nasal medication produces significant improvement in both symptoms and inflammation inside the sinuses for patients with chronic sinusitis, regardless of whether or not nasal polyps are present, and to show reduction in the number of acute exacerbations.

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Compared with diclofenac, buprenorphine more effective for Pain Relief in Acute Pancreatitis: Study

Compared with diclofenac, buprenorphine is more effective for Pain Relief in Acute Pancreatitis suggests a new study published in the Clinical Gastroenterology and Hepatology.

Although both nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids are used for analgesia in acute pancreatitis (AP), the analgesic of choice is not known. They compared buprenorphine, an opioid, and diclofenac, an NSAID, for analgesia in acute pancreatitis In a double-blind randomized controlled trial, acute pancreatitis patients were randomized to receive intravenous diclofenac or intravenous buprenorphine. Fentanyl was used as rescue analgesia, delivered through a patient-controlled analgesia pump. The primary outcome was the difference in the dose of rescue fentanyl required. Secondary outcomes were the number of effective and ineffective demands of rescue fentanyl, pain-free interval, reduction in visual analogue scale (VAS) score, adverse events, and organ failure development. Results: Twenty-four patients were randomized to diclofenac and 24 to buprenorphine. The 2 groups were matched at baseline. The total amount of rescue fentanyl required was significantly lower in the buprenorphine group:130 μg, interquartile range (IQR), 80–255 vs 520 μg, IQR, 380–1065 (P < .001). The number of total demands was 32 (IQR, 21–69) in the diclofenac arm vs 8 (IQR, 4–15) in the buprenorphine arm (P < .001). The buprenorphine group had a more prolonged pain-free interval (20 vs 4 hours; P < .001), with greater reduction in the VAS score at 24, 48, and 72 hours compared with the diclofenac group. These findings were confirmed in the subgroup of moderately severe/severe pancreatitis. Adverse events profile was similar in the 2 groups. Compared with diclofenac, buprenorphine appears to be more effective and equally safe for pain management in acute pancreatitis patients, even in the subcohort of moderately severe or severe pancreatitis

Reference:

Mayank Saini, Jayanta Samanta, Antriksh Kumar, Arup Choudhury, Jahnvi Dhar, Anudeep Jafra, Rajeev Chauhan, Gaurav Muktesh, Pankaj Gupta, Vikas Gupta, Thakur Deen Yadav, Rakesh Kochhar, Gabriele Capurso, Enrique De-Madaria, Antonio Facciorusso. Buprenorphine Versus Diclofenac for Pain Relief in Acute Pancreatitis: A Double-Blinded Randomized Controlled Trial. Clinical Gastroenterology and Hepatology, Volume 22, Issue 3. 2024,Pages 532-541.e8,ISSN 1542-3565,https://doi.org/10.1016/j.cgh.2023.10.021. (https://www.sciencedirect.com/science/article/pii/S1542356523008649)

Keywords:

diclofenac, buprenorphine, effective, Pain Relief, Acute Pancreatitis, study, Clinical Gastroenterology and Hepatology, Mayank Saini, Jayanta Samanta, Antriksh Kumar, Arup Choudhury, Jahnvi Dhar, Anudeep Jafra, Rajeev Chauhan, Gaurav Muktesh, Pankaj Gupta, Vikas Gupta, Thakur Deen Yadav, Rakesh Kochhar, Gabriele Capurso, Enrique De-Madaria, Antonio Facciorusso, Nonsteroidal Anti-inflammatory Drugs; Opioids; Analgesics; Visual Analogue Scale; Patient-Controlled Analgesia

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Lotilaner ophthalmic solution may improve clinical signs of Demodex blepharitis for up to one year: Study

Lotilaner ophthalmic solution may improve clinical signs of Demodex blepharitis for up to one year suggests a study published in the Cornea.

This study aimed to evaluate the long-term outcomes of lotilaner ophthalmic solution, 0.25%, in the treatment of Demodex blepharitis. This observational, extension study included patients with Demodex blepharitis (N = 239) who completed the Saturn-1 study and presented for the day 180 visit. All participants were assessed at days 180 and 365 after the initiation of 6-week treatment with the study drug or its vehicle. Results: The proportion of patients with 0 to 2 collarettes (grade 0) was significantly higher in the study group (N = 128 patients) than in the control group (N = 111 patients) (39.8% vs. 2.7% at day 180 and 23.5% vs. 2.9% at day 365; P < 0.0001). Similarly, the proportion of patients with ≤10 collarettes (collarette grade 0–1) in the study group was significantly higher than in the control group (70.3% vs. 18.0% at day 180 and 62.6% vs. 21.9% at day 365; P < 0.0001). In the study group, erythema continued to improve even after completion of the 6-week lotilaner treatment. No serious ocular adverse events were observed in the study group, and there was 1 treatment-related ocular adverse event in the study group, which was considered mild.

After 6-week treatment with lotilaner ophthalmic solution, 0.25%, for Demodex blepharitis, no long-term concerns were observed during 1 year of follow-up. A high proportion of patients with 0 to 2 collarettes (grade 0) or ≤10 collarettes (collarette grade of 0 or 1) was observed throughout 1 year of follow-up, indicating that the efficacy of lotilaner ophthalmic solution, 0.25%, against Demodex blepharitis may last well after completion of therapy.

Reference:

Sadri, Ehsan MD*; Paauw, James D. MD†; Ciolino, Joseph B. MD‡; Nijm, Lisa MD, JD§; Simmons, Blake OD¶; Meyer, John MD║; Gaddie, Ian Benjamin OD**; Berdy, Gregg J. MD††; Holdbrook, Mark BA‡‡; Baba, Stephanie N. OD‡‡; Jalalat, Parisa OD*; Yeu, Elizabeth MD§§. Long-Term Outcomes of 6-Week Treatment of Lotilaner Ophthalmic Solution, 0.25%, for Demodex Blepharitis: A Noninterventional Extension Study. Cornea ():10.1097/ICO.0000000000003484, February 9, 2024. | DOI: 10.1097/ICO.0000000000003484

Keywords:

Lotilaner, ophthalmic solution, clinical signs, Demodex blepharitis, one-year, Cornea, Sadri, Ehsan MD*; Paauw, James D. MD†; Ciolino, Joseph B. MD‡; Nijm, Lisa MD, JD§; Simmons, Blake OD¶; Meyer, John MD║; Gaddie, Ian Benjamin OD**; Berdy, Gregg J. MD††; Holdbrook, Mark BA‡‡; Baba, Stephanie N. OD‡‡; Jalalat, Parisa OD*; Yeu, Elizabeth

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The rainbow of urine colors: What’s typical, what’s not

Regular urine color varies but usually ranges from clear to pale yellow. The exact hue depends on how much water you drink. Fluids dilute the yellow pigments in urine. So the more you drink, the clearer your urine looks. When you drink less, the yellow color becomes stronger.

Some foods and medications can change the color of urine. For example, foods like beets, blackberries and fava beans can turn urine pink or red. Some medications also can give urine vivid tones, such as orange or greenish-blue.

An unusual urine color also can be a sign of a health problem, however. For instance, some urinary tract infections can turn urine milky white. Kidney stones, some cancers and other diseases sometimes make urine look red due to blood.

Here are some unusual urine colors, along with things that can cause them.

Red or pink urine

Red urine isn’t always a sign of a serious health problem. Red or pink urine can be caused by:

  • Blood: Health problems that can cause blood in the urine include an enlarged prostate, tumors that aren’t cancer, and kidney stones and cysts. Vigorous exercise also can cause blood in the urine. Blood in the urine is common in urinary tract infections and with kidney stones. Those problems often cause pain. Painless bleeding might be a sign of a more serious problem, such as cancer.
  • Foods: Beets, blackberries and rhubarb can turn urine red or pink.
  • Medicines: Red or pink urine is possible if you take medications for tuberculosis, urinary tract pain or constipation.

Orange urine

Orange urine can be caused by:

  • Medicines: Constipation medicines can turn urine orange, as can medicine that lessens swelling and irritation, and some chemotherapy medicines for cancer.
  • Vitamins: Some vitamins, such as A and B-12, can turn urine orange or yellow-orange.
  • Health problems: Orange urine can be a sign of a problem with the liver or bile duct, mainly if you also have light-colored stools. Dehydration also can make your urine look orange.

Blue or green urine

Blue or green urine can be caused by:

  • Dyes: Some brightly colored food dyes can cause green urine. Dyes used for some kidney and bladder tests can turn urine blue.
  • Medicines: Some medicines for depression, ulcers and acid reflux can turn urine greenish-blue. Medications for pain, arthritis and sleep also can turn urine green.
  • Health problems: A rare disease called familial benign hypercalcemia can cause children to have blue urine. Urinary tract infections caused by a certain bacteria can cause green urine.

Dark brown or cola-colored urine

Brown urine can be caused by:

  • Foods: Eating lots of fava beans, rhubarb or aloe can cause dark brown urine.
  • Medicines: Some medicines can darken urine, including those used to treat and prevent malaria, constipation, high cholesterol and seizures. Some antibiotics and muscle relaxers also can darken urine.
  • Health problems: Some liver and kidney disorders and urinary tract infections can turn urine dark brown. So can bleeding inside the body, called a hemorrhage. A group of illnesses mainly affecting the skin or the nervous system, called porphyria, also can cause brown urine.
  • Extreme exercise: A muscle injury from extreme training can cause tea- or cola-colored urine. The injury can lead to kidney damage.

Cloudy or murky urine

Urinary tract infections and kidney stones can cause urine to look cloudy or murky.

Keep in mind that colors can look slightly different to different people. For instance, what looks red to you might look orange to someone else. Talk with your healthcare team if you have concerns and in particular if you have painful urination or dark orange urine, which can be a sign that your liver isn’t working correctly.

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Enhancing greenness in residential communities mitigates preterm birth associated with heat exposure:JAMA

Enhancing greenness in residential communities may mitigate adverse association of heat exposure with preterm birth suggests a new study published in the JAMA Pediatrics.

Preterm birth (PTB) is associated with adverse health outcomes. The outcomes of heat exposure during pregnancy and the moderating association of greenness with PTB remain understudied. A study was done to investigate associations between heat exposure, greenness, and PTB, as well as interactions between these factors. Participants Included in this cohort study were births occurring in Sydney, New South Wales, Australia, between 2000 and 2020, retrieved from New South Wales Midwives Data Collection. Participants with incomplete or missing data on their residential address or those who resided outside of New South Wales during their pregnancy were excluded. Data were analyzed from March to October 2023. Greenness measured using normalized difference vegetation index (NDVI) and tree cover derived from satellite images. Daily extreme heat and nighttime extreme heat were defined as above the 95th percentile of community- and trimester-specific daily mean temperatures and nighttime temperatures. Logistic regression models estimated the independent association of extreme heat with PTB, adjusting for individual- and area-level covariates, season of conception, and long-term trend. An interaction term between extreme heat exposure and greenness was included to explore potential modification. With a significant interaction observed, the number of preventable heat-associated PTBs that were associated with greenness was estimated. Results: A total of 1 225 722 births (median [IQR] age, 39 [38-40] weeks; 631 005 male [51.5%]) were included in the analysis, including 63 144 PTBs (median [IQR] age, 35 [34-36] weeks; 34 822 male [55.1%]). Compared with those without heat exposure, exposure to daily extreme heat and nighttime extreme heat in the third trimester was associated with increased risks of PTB, with an adjusted odds ratio (OR) of 1.61 (95% CI, 1.55-1.67) and 1.51 (95% CI, 1.46-1.56]), respectively (PTB rates: exposed, 4615 of 61 338 [7.5%] vs unexposed, 56 440 of 1 162 295 [4.9%] for daily extreme heat and 4332 of 61 337 [7.1%] vs 56 723 of 1 162 296 [4.9%] for nighttime extreme heat). Disparities in associations between extreme heat exposure and PTB were observed, with lower odds of PTB among pregnant individuals residing in greener areas. The associations between extreme heat exposure and PTB could be mitigated significantly by higher greenness. Improving NDVI and tree cover could reduce daily extreme heat-associated PTB by 13.7% (95% CI, 2.3%-15.1%) and 20.9% (95% CI, 5.8%-31.5%), respectively. For nighttime extreme heat-associated PTB, reductions were 13.0% (0.2%-15.4%) and 17.2% (4.1%-27.0%), respectively Results of this large birth cohort study suggest that extreme heat exposure was adversely associated with PTB, with greenness playing a moderating role. Increasing greenness levels in residential communities could prevent heat-associated PTBs. These findings emphasize the importance of integrating heat mitigation strategies and improving green space in urban planning and public health interventions.

Reference:

Ye T, Guo Y, Huang W, Zhang Y, Abramson MJ, Li S. Heat Exposure, Preterm Birth, and the Role of Greenness in Australia. JAMA Pediatr. Published online February 26, 2024. doi:10.1001/jamapediatrics.2024.0001

Keywords:

Enhancing, greenness, residential communities, mitigate, adverse, association, heat exposure, preterm birth, JAMA Pediatrics, Ye T, Guo Y, Huang W, Zhang Y, Abramson MJ, Li S

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Long-Term Exercise Therapy Improves Functional Outcomes among Rheumatoid Arthritis patients: BMJ

A recent study published in the Annals of the Rheumatic Diseases found the effectiveness of longstanding supervised exercise therapy in individuals with rheumatoid arthritis (RA) and severe functional limitations.

This comprehensive study enrolled a total of 217 participants who were primarily females with an average age of 58.8 years. The participants were randomly assigned to either receive individualized goal-setting, active exercises, education and self-management regarding physical activity (the intervention group) or to continue with usual care.

The primary endpoint of the study was the change in the Patient-Specific Complaints activity ranked 1 (PSC1, 0–10) at 52 weeks. Secondary endpoints included various measures such as the Health Assessment Questionnaire-Disability Index (HAQ-DI), Rheumatoid Arthritis Quality of Life Questionnaire (RAQoL) and the 6-minute walk test (6MWT) among others.

The results at the 52-week mark revealed a significant improvement in the PSC1 in the intervention group when compared to usual care. Also, secondary outcomes also showed remarkable enhancements in the intervention group, except for the SF-36 Mental Component Summary (MCS). These secondary outcomes included improved physical function, quality of life and increased walking distance.

This study also observed the occurrence of only one mild, transient adverse event in the intervention group which highlights the safety of supervised exercise therapy. Overall, the findings underscore the importance of longstanding, supervised exercise therapy in managing RA in the individuals with severe functional limitations.

Source:

Teuwen, M. M. H., van Weely, S. F. E., Vliet Vlieland, T. P. M., van Wissen, M. A. T., Peter, W. F., den Broeder, A. A., van Schaardenburg, D., van den Hout, W. B., Van den Ende, C. H. M., & Gademan, M. G. J. (2024). Effectiveness of longstanding exercise therapy compared with usual care for people with rheumatoid arthritis and severe functional limitations: a randomised controlled trial. In Annals of the Rheumatic Diseases (Vol. 83, Issue 4, pp. 437–445). BMJ. https://doi.org/10.1136/ard-2023-224912

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High HbA1c levels levels at admission tied to chronic fatigue after acute ischemic stroke: Study and post-stroke fatigue

A recent study conducted at the Suining Central Hospital, China uncovered a significant connection between blood sugar levels and Chronic Post-Stroke Fatigue (PSF), a prevalent and persistent complication among the ischemic stroke survivors. The key findings of this study was published in the recent edition of Experimental Gerontology journal.

This study focused on a total of 559 patients who experienced their first Acute Ischemic Stroke (AIS) and the importance of monitoring serum glycated hemoglobin (HbA1c) levels in stroke patients. Over a six-month period following the stroke onset, patients were assessed using the Fatigue Severity Scale (FSS) to measure fatigue symptoms. This study marks the first of its kind to investigate the relationship between HbA1c and PSF.

The results revealed a sharp correlation between the elevated HbA1c levels and the occurrence of PSF. Also, patients who reported PSF expressed significantly higher levels of HbA1c when compared to those without PSF. A non-linear dose-response relationship was observed, indicating that higher HbA1c levels at admission were independently associated with a greater risk of chronic PSF.

The study highlights the pivotal role of glycemic management in reducing the risk of chronic PSF among the stroke survivors. Healthcare providers can potentially improve the quality of life for stroke patients by closely monitoring HbA1c levels and implementing long-term strategies to regulate blood sugar.

While this research reaffirmed the significance of HbA1c as a stable predictor of chronic PSF, it also observed variability in the correlation between blood glucose levels and fatigue symptoms. While a linear positive correlation was observed between PSF and discharge blood glucose levels, no significant correlation was found for blood glucose levels upon admission.

Reference:

Ouyang, Q., Xu, L., Zhang, Y., Huang, L., Du, Y., & Yu, M. (2024). Relationship between glycated hemoglobin levels at admission and chronic post-stroke fatigue in patients with acute ischemic stroke. In Experimental Gerontology (Vol. 188, p. 112395). Elsevier BV. https://doi.org/10.1016/j.exger.2024.112395

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Oil Palm Pollen Sensitization Linked to Allergic Diseases in new study

A recent study found the significant association between Elaeis guineensis (Ela g, oil palm) pollen sensitization and allergic diseases in the tropical Southeast Asian region. The key findings of this study were published in the recent edition of World Allergy Organization Journal.

The study was conducted as part of the Singapore and Malaysia cross-sectional genetic and epidemiological study (SMCSGES) looked into the largely unexplored field of allergic diseases and their relation to oil palm pollen sensitization. This research involved two independent cohorts; the first cohort consisted of 564 participants from Singapore and Malaysia with serum samples collected and analyzed against a panel of 16 crude inhalant allergens. The results revealed a startling sensitization rate of 9.6% to oil palm pollen.

Further, in a larger cohort of 13,652 young adults from Singapore/Malaysia Chinese the skin prick tests were taken to assess oil palm sensitization. The findings revealed that individuals who were sensitized to oil palm pollen expressed significantly high risks of asthma, allergic rhinitis (AR) and atopic dermatitis (AD). The individuals with asthma and oil palm sensitization had elevated risk of experiencing wheezing, nocturnal cough and exacerbations in the past 12 months. Similarly, AR patients with oil palm sensitization underwent a higher likelihood of developing moderate-to-severe symptoms.

These findings highlight the critical role of oil palm pollen in exacerbating allergic diseases in the Southeast Asian region, Understanding these associations is crucial for devising targeted preventive and management strategies to reduce the burden of allergic diseases in our population.

Reference:

Sio, Y. Y., Victoria Nanong, G. A., Lim, J. A., Matta, S. A., Say, Y.-H., Teh, K. F., Wong, Y. R., Rawanan Shah, S. M., Reginald, K., & Chew, F. T. (2024). Sensitization to oil palm pollen associates with risks and severity of allergic diseases. In World Allergy Organization Journal (Vol. 17, Issue 1, p. 100853). Elsevier BV. https://doi.org/10.1016/j.waojou.2023.100853

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Robotic Surgery on the Rise in Emergency Procedures: Study Shows Promising Outcomes

In
a noteworthy shift in the landscape of emergency general surgery, robotic
procedures are increasingly making their mark, offering potential advantages in
outcomes, according to a comprehensive retrospective cohort study conducted
across 829 US facilities. The study states that robotic surgery which has
traditionally been associated with elective procedures, illuminates its
increasing role in emergency general surgery.


The
study results were published in the journal JAMA Surgery.

Also Read: Robotic-assisted surgery and navigation do not alter the risk of PJI after total hip replacement surgery

In
the realm of surgical interventions, robotic surgery has firmly established
itself as a go-to approach for a diverse array of elective operations. However,
when it comes to emergency general surgery, there exists a notable gap in
comprehensive data regarding the utility and outcomes of robotic procedures.
Hence researchers conducted a study to understand the trajectory of robotic and
laparoscopic approaches in emergency settings. Published after extensive
data analysis from July 2022 to November 2023, the study delved into the
utilization and outcomes of laparoscopic and robotic approaches for emergent
surgical procedures, focusing on cholecystectomy, colectomy, inguinal hernia repair,
and ventral hernia repair.


From
2013 to 2021, a retrospective cohort study analyzed a discharge database from
829 US facilities, covering 1,067,263 emergent surgeries. Surgical approaches
(robotic, laparoscopic, or open) were assessed for temporal trends, conversion
rates, and length of stay. Temporal trends were measured through linear
regression, and propensity score matching compared outcomes between robotic and
laparoscopic surgery groups.


Findings:

  • Over
    the observed period from 2013 to 2021, robotic surgery exhibited a consistent
    year-over-year increase for all examined procedures.

  • Notable percentages
    included a 0.7% rise for cholecystectomy, 0.9% for colectomy, 1.9% for inguinal
    hernia repair, and 1.1% for ventral hernia repair.

  • This
    trend was accompanied by a corresponding decrease in the conventional open
    surgical approach across the board.


  • Robotic
    surgery was associated with a significantly lower risk of conversion to open
    surgery in all four procedures.
  • For instance, in cholecystectomy, the
    conversion risk was 1.7% for robotic surgery compared to 3.0% for laparoscopy.

  • Similar
    trends were observed in colectomy, inguinal hernia repair, and ventral hernia
    repair, with robotic surgery consistently demonstrating lower conversion rates.


  • Furthermore,
    the study revealed a notable advantage in postoperative lengths of stay for
    patients undergoing robotic surgery.

  • Specifically,
    colectomy, inguinal hernia repair, and ventral hernia repair displayed shorter
    stays for the robotic surgery cohort.

  • The
    reduced length of stay suggests a potential improvement in recovery times and
    resource utilization, marking a positive development for both patients and
    healthcare systems.

     

Also Read: Robotic Surgery Boosts outcomes of Colorectal Cancer


While
the adoption of robotic surgery in emergency settings is not yet ubiquitous,
the study underscores a growing trend and suggests promising outcomes
associated with this advanced approach. As technological advancements continue
to shape the field of surgery, the increasing prevalence of robotics in
emergency procedures holds the potential to enhance patient outcomes and
redefine standards in emergency general surgery. The findings provide valuable
insights for the medical community, paving the way for further exploration of
the role of robotics in emergency settings.

Further reading: Lunardi N, Abou-Zamzam A, Florecki KL, et al. Robotic Technology in Emergency General Surgery Cases in the Era of Minimally Invasive Surgery. JAMA Surg. Published online March 06, 2024. doi:10.1001/jamasurg.2024.0016

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AstraZeneca Gets CDSCO Panel Nod to Study anticancer drug Volrustomig

New Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the study of the anticancer drug Volrustomig (MEDI5752).

This came after the drug maker AstraZeneca presented phase III clinical study protocol No. D798EC00001.

This is a global study of Volrustomig (MEDI5752) for participants with unresected locally advanced head and neck squamous cell carcinoma following definitive concurrent chemoradiotherapy (eVOLVE-HNSCC).

The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).

MEDI5752 is a monovalent bispecific antibody designed to suppress the PD-1 pathway and provide modulated CTLA4 inhibition favoring enhanced blockade on PD-1+ activated T cells.

At the recent SEC meeting for Oncology held on 21st February 2023, the expert panel reviewed the Phase III CT protocol No. D798EC00001.

After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm.

Also Read:Synokem gets CDSCO Panel Nod To Study FDC Dapagliflozin plus Sacubitril plus Valsartan

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