Mechanical and oral antibiotic bowel preparation may reduce morbidity in patients undergoing elective rectal resection: JAMA

Mechanical and oral antibiotic bowel preparation may reduce morbidity in patients undergoing elective rectal resection suggests a new study published in the JAMA.

Surgical site infections (SSIs)—especially anastomotic dehiscence—are major contributors to morbidity and mortality after rectal resection. The role of mechanical and oral antibiotics bowel preparation (MOABP) in preventing complications of rectal resection is currently disputed. A study was done to assess whether MOABP reduces overall complications and SSIs after elective rectal resection compared with mechanical bowel preparation (MBP) plus placebo. This multicenter, double-blind, placebo-controlled randomized clinical trial was conducted at 3 university hospitals in Finland between March 18, 2020, and October 10, 2022. Patients aged 18 years and older undergoing elective resection with primary anastomosis of a rectal tumour 15 cm or less from the anal verge on magnetic resonance imaging were eligible for inclusion. Outcomes were analyzed using a modified intention-to-treat principle, including all patients randomly allocated to and underwent elective rectal resection with an anastomosis. Patients were stratified according to tumour distance from the anal verge and neoadjuvant treatment given and randomised in a 1:1 ratio to receive MOABP with an oral regimen of neomycin and metronidazole (n = 277) or MBP plus matching placebo tablets (n = 288). All study medications were taken the day before surgery, and all patients received intravenous antibiotics approximately 30 minutes before surgery. The primary outcome was overall cumulative postoperative complications measured using the Comprehensive Complication Index. Key secondary outcomes were SSI and anastomotic dehiscence within 30 days after surgery. Results In all, 565 patients were included in the analysis, with 288 in the MBP plus placebo group and 277 in the MOABP group. Patients in the MOABP group experienced fewer overall postoperative complications; Wilcoxon effect size, 0.146; P < .001), fewer SSIs, and fewer anastomotic dehiscences compared with patients in the MBP plus placebo group. Findings of this randomized clinical trial indicate that MOABP reduced overall postoperative complications and rates of SSIs and anastomotic dehiscences in patients undergoing elective rectal resection compared with MBP plus placebo. Based on these findings, MOABP should be considered as standard treatment in patients undergoing elective rectal resection.

Reference:

Koskenvuo L, Lunkka P, Varpe P, et al. Morbidity After Mechanical Bowel Preparation and Oral Antibiotics Prior to Rectal Resection: The MOBILE2 Randomized Clinical Trial. JAMA Surg. Published online March 20, 2024. doi:10.1001/jamasurg.2024.0184

Keywords:

Mechanical, oral antibiotic, bowel preparation, reduce, morbidity, patients, undergoing, elective rectal resection, JAMA, Koskenvuo L, Lunkka P, Varpe P

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Neurological Manifestations in COVID-19 patients Linked to Poor Long-Term Outcomes, claims study

Neurological complications have emerged as a significant concern in patients with Coronavirus Disease 2019 (COVID-19). A recent retrospective cohort study investigated the long-term outcomes of patients with and without neurological manifestations during their initial COVID-19 hospitalization. This study was published in PLoS Medicine journal. The study was conducted by Anna E. and colleagues.

The study aimed to shed light on the association between neurological involvement and post-discharge morbidity and mortality. Acute neurological manifestations are increasingly recognized as complications of COVID-19, affecting a considerable proportion of patients. However, the long-term implications of these neurological symptoms remain unclear.

Researchers analyzed data from patients admitted for COVID-19 at the Montefiore Health System in the Bronx, New York, during the early stages of the pandemic. A total of 414 patients with significant neurological manifestations were compared with 1,199 propensity-matched patients without such manifestations. Follow-up data were collected over a 3-year period to assess outcomes.

The key findings of the study were as follows:

  • Demographic characteristics were similar between the two cohorts, with no significant differences in sex distribution and ICU status. However, the neurological cohort had a higher proportion of black non-Hispanic patients.

  • Patients with neurological manifestations experienced higher rates of adverse outcomes post-discharge. This included increased mortality, stroke, major adverse cardiovascular events (MACE), and hospital readmission.

  • Mortality was significantly elevated in the neurological cohort compared to controls (hazard ratio: 2.346, p < 0.001).

  • Neurological cohort patients were more frequently discharged to acute rehabilitation or skilled nursing facilities and less often discharged home.

  • They exhibited higher incidences of stroke, MACE, and readmission post-discharge.

  • Several factors were associated with increased mortality post-discharge, including neurological manifestations, discharge disposition, congestive heart failure, higher COVID-19 severity score, and older age.

  • While both cohorts showed similar rates of radiological abnormalities, the neurological cohort exhibited significantly more age-adjusted brain volume loss.

The study’s findings highlight the profound impact of neurological involvement on the trajectory of COVID-19 illness. Patients with significant neurological manifestations faced a multitude of challenges, including higher rates of readmission, cardiovascular events, and mortality even after discharge from the hospital. These results underscore the importance of considering neurological symptoms as crucial markers of disease severity and prognosis in COVID-19 patients.

This study provides compelling evidence of the detrimental impact of neurological manifestations on the long-term outcomes of COVID-19 patients. By recognizing the significance of neurological involvement in COVID-19, healthcare providers can better anticipate and address the complex needs of affected individuals, ultimately improving patient care and clinical outcomes.

Reference:

Eligulashvili, A., Gordon, M., Lee, J. S., Lee, J., Mehrotra-Varma, S., Mehrotra-Varma, J., Hsu, K., Hilliard, I., Lee, K., Li, A., Essibayi, M. A., Yee, J., Altschul, D. J., Eskandar, E., Mehler, M. F., & Duong, T. Q. (2024). Long-term outcomes of hospitalized patients with SARS-CoV-2/COVID-19 with and without neurological involvement: 3-year follow-up assessment. PLoS Medicine, 21(4), e1004263. https://doi.org/10.1371/journal.pmed.1004263

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Inhaled treprostinil cuts mortality among patients of pulmonary hypertension associated with ILD: Study

Inhaled treprostinil cuts mortality among patients of pulmonary hypertension associated with interstitial lung disease suggests a study published in the BMJ thorax.

A post-hoc analysis of the INCREASE trial and its open-label extension (OLE) was performed to evaluate whether inhaled treprostinil has a long-term survival benefit in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). Two different models of survival were employed; the inverse probability of censoring weighting (IPCW) and the rank-preserving structural failure time (RPSFT) models both allow construction of a pseudo-placebo group, thereby allowing for long-term survival evaluation of patients with PH-ILD receiving inhaled treprostinil. Time-varying stabilised weights were calculated by fitting Cox proportional hazards models based on the baseline and time-varying prognostic factors to generate weighted Cox regression models with associated adjusted HRs. Results In the INCREASE trial, there were 10 and 12 deaths in the inhaled treprostinil and placebo arms, respectively, during the 16-week randomised trial. During the OLE, all patients received inhaled treprostinil and there were 29 and 33 deaths in the prior inhaled treprostinil arm and prior placebo arm, respectively. With a conventional analysis, the HR for death was 0.71 (95% CI 0.46 to 1.10; p=0.1227). Both models demonstrated significant reductions in death associated with inhaled treprostinil treatment with HRs of 0.62 (95% CI 0.39 to 0.99; p=0.0483) and 0.26 (95% CI 0.07 to 0.98; p=0.0473) for the IPCW and RPSFT methods, respectively. Two independent modelling techniques that have been employed in the oncology literature both suggest a long-term survival benefit associated with inhaled treprostinil treatment in patients with PH-ILD.

Reference:

Nathan SD, Johri S, Joly JM, et alSurvival analysis from the INCREASE study in PH-ILD: evaluating the impact of treatment crossover on overall mortalityThorax 2024;79:301-306.

Keywords:

Inhaled, treprostinil cuts, mortality, patients, pulmonary, hypertension, interstitial lung disease, Study , BMJ thorax, Nathan SD, Johri S, Joly JM

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Peritoneal dialysis patients with longer serum phosphorus time in range tied to lower mortality risk: Study

China: A multicenter retrospective cohort study has revealed an association between longer serum phosphorus time in range and a lower mortality risk among peritoneal dialysis patients.

The findings, published in BMC Nephrology, highlight the importance of maintaining serum phosphorus levels within 1.13–1.78 mmol/L for peritoneal dialysis patients.

Mineral bone disease (MBD) is a common complication of end-stage kidney disease. Serum phosphorus is an essential element of the human body that is proven to be a central indicator in MBD and is critical for the initiation and progression of cardiovascular calcification (CVC), which is strongly related to cardiovascular (CV) events, CV mortality, and all-cause mortality. For every rise in 0.323 mmol/L (1 mg/dL) in phosphorus level, the risk of all-cause mortality and CV mortality increased by 18% and 13%, respectively.

Major studies about the phosphorus-mortality relationship have focused on the hemodialysis (HD) population, and the relationship between serum phosphorus time in range and mortality risk in peritoneal dialysis patients remains uncertain. Therefore, Guobao Wang, Guangdong Provincial Key Laboratory of Renal Failure Research, Guangzhou, China, and colleagues aimed to evaluate the association between serum phosphorus time in range and all-cause mortality in the Chinese PD population.

For this purpose, the researchers conducted a multicenter, retrospective, cohort study of 1,915 patients collected from 2008 to 2020 in four Chinese centers. Serum phosphorus time in range was estimated as the months during the first year a patient’s serum phosphorus level was within the target range (defined as 1.13–1.78 mmol/L).

The study’s primary outcome was all-cause mortality. The secondary outcomes included CV mortality and PD withdrawal. The association was assessed using the Cox proportional hazards regression model with comprehensive adjustments.

The study revealed the following findings:

· The primary outcome occurred in 13.0% of PD patients over a median follow-up of 28 months.

· The serum phosphorus time in range was negatively associated with all-cause mortality (per 3-month increments, adjusted HR [aHR], 0.83), PD withdrawal (per 3-month increments, aHR, 0.89), and CV mortality (per 3-month increments, aHR, 0.87).

· Competing-risk model showed that the relationship of serum phosphorus time in range with all-cause mortality remained stable.

· None of the variables including demographics, history of diabetes and CV disease, and several PD-related and clinical indicators modified this association.

In conclusion, the researchers observed that longer serum phosphorus time in range in the first year was significantly associated with lower all-cause mortality and CV mortality risk in PD patients. The findings stress the importance of maintaining serum phosphorus concentration within 1.13–1.78 mmol/L for PD patients.

“If confirmed, these findings suggest a potential avenue to improve clinical outcomes in this population,” the researchers wrote.

Reference:

Huo, Z., Liu, D., Ye, P. et al. Longer serum phosphorus time in range associated with lower mortality risk among peritoneal dialysis patients: a multicenter retrospective cohort study. BMC Nephrol 25, 117 (2024). https://doi.org/10.1186/s12882-023-03395-9

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Persistent postoperative hyperglycemia tied to increased risk of mortality in patients undergoing elective craniotomy: Study

China: A recent study published in the Journal of Neurosurgery has shown an association of moderate and severe persistent postoperative hyperglycemia with an increased mortality risk compared with normoglycemia in patients undergoing an elective craniotomy. The association was observed regardless of whether patients had preoperative hyperglycemia.

The impact of persistent postoperative hyperglycemia after craniotomy has not been explored yet. Considering this, Jialing He, Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, and colleagues aimed to investigate the hypothesis that persistent postoperative hyperglycemia is associated with mortality in patients undergoing an elective craniotomy.

Adult patients (age ≥ 18 years) undergoing an elective craniotomy between 2011 and 2021 at the West China Hospital, Sichuan University, were included in the study. Peak daily blood glucose values measured within the first seven days following craniotomy were collected.

Persistent hyperglycemia was defined by two or more consecutive serum glucose levels of mild, moderate, or severe hyperglycemia. Severe hyperglycemia, moderate hyperglycemia, mild hyperglycemia, and normoglycemia were defined as glucose values of > 10.0 mmol/L, > 7.8 and ≤ 10.0 mmol/L, 6.1 and ≤ 7.8 mmol/L, and ≤ 6.1 mmol/L, respectively.

A total of 14,907 patients undergoing an elective craniotomy were included. The study led to the following findings:

  • In the multivariable analysis, moderate (adjusted OR 3.76) and severe (adjusted OR 3.82) persistent hyperglycemia in patients were associated with higher 30-day mortality compared with normoglycemia. However, this association was not observed in patients with mild hyperglycemia (adjusted OR 1.32).
  • The association was observed regardless of whether patients had preoperative hyperglycemia.
  • There was no interaction between moderate or severe hyperglycemia and preexisting diabetes.
  • When postoperative peak blood glucose values within the first 7 days after craniotomy were evaluated as a continuous variable, for each 1-mmol/L increase in blood glucose, the adjusted OR of 30-day mortality was 1.17.
  • Postoperative blood glucose (area under the curve [AUC] = 0.78) was superior to preoperative blood glucose (AUC = 0.65) for predicting mortality.
  • Moderate and severe persistent hyperglycemia in patients was associated with an increased risk of deep venous thrombosis (adjusted OR 3.20), myocardial infarction (adjusted OR 4.38), pneumonia (adjusted OR 2.77), and prolonged hospital stays (adjusted OR 1.43).

In conclusion, the study assessed the association of persistent postoperative hyperglycemia with mortality after elective craniotomy. The results showed that in this population, moderate and severe persistent postoperative hyperglycemia were associated with an increased risk of mortality compared with normoglycemia, irrespective of preoperative hyperglycemia.

Reference:

He, Jialing, et al. “Association of Persistent Postoperative Hyperglycemia With Mortality After Elective Craniotomy.” Journal of Neurosurgery, vol. 140, no. 4, 2024, pp. 1080-1090.

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Aceclidine-based Eye Drops Effective in Treating Presbyopia, reveals phase 3 trial

The recent press release from a prominent biopharmaceutical company, LENZ Therapeutics, Inc. unveiled promising findings from its Phase 3 CLARITY study making a significant stride forward in the treatment of presbyopia. The study evaluated two formulations of aceclidine, LNZ100 and LNZ101 by demonstrating their potential to enhance the near vision in individuals with presbyopia.

Presbyopia is characterized by the gradual loss of near vision typically experienced by the individuals over 45 years and affects millions throughout the globe. This impacts the daily activities like reading and close-up work. The breakthrough of LENZ involves the development of aceclidine-based eye drops to reduce the effects of this condition to alternate the traditional corrective aids like reading glasses.

The Phase 3 trials comprised CLARITY 1 and 2 that showed compelling efficacy and safety profiles for LNZ100 with statistically significant improvements in Best Corrected Distance Visual Acuity (BCDVA) at near observed in the participants. Also, LNZ100 expressed rapid onset, sustained efficacy and reproducible near vision improvement across the diverse age groups and refractive ranges. Both LNZ100 and LNZ101 met primary and secondary endpoints, with LNZ100 emerging as the lead candidate due to its superior performance. Also, LNZ100 demonstrated a elevated responder rate and prolonged efficacy which garnered positive feedback from participants and investigators alike.

The President and CEO of LENZ Therapeutics expressed satisfaction with the study outcomes that emphasized the potential of LNZ100 as a promising therapy for presbyopia. With plans to submit a New Drug Application (NDA) in mid-2024, LENZ advances toward the commercialization to address the needs of the vast presbyopic population in the United States. The Chief Medical Officer of LENZ Therapeutics elucidated the transformative impact of LNZ100 by highlighting its ability to reduce the burdens associated with presbyopia and provide a convenient treatment option for affected individuals.

The successful completion of the CLARITY trials underlines the commitment of LENZ Therapeutics to the pioneering advancements in ophthalmic care. With further data presentations anticipated, the company remains poised to move the landscape of presbyopia management. LENZ Therapeutics is set to host a conference call and webcast to discuss the major results by providing stakeholders with insights into the potential of aceclidine-based eye drops in reshaping the treatment paradigm for presbyopia. This prevalent age-related vision disorder stands to witness a trend shift with the innovative approach of LENZ Therapeutics by offering hope to millions with presbyopia.

Reference:

LENZ Therapeutics announces positive topline data from phase 3 CLARITY presbyopia trials. News release. LENZ Therapeutics. April 6, 2024. https://www.businesswire.com/news/home/20240403843686/en/LENZ-Therapeutics-Announces-Positive-Topline-Data-from-Phase-3-CLARITY-Presbyopia-Trials.

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Eli Lilly Gets CDSCO Panel Nod To Market Mirikizumab for ulcerative colitis in adults

New Delhi: Pharmaceutical major Eli Lilly has got marketing authorization from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) for Mirkizumab Injection 300mg/15mL solution in vial and 100mg/mL solution in Prefilled Syringe (PFS) indicated for the treatment of moderate to severe active ulcerative colitis in adult.

This came after the drug maker Eli Lilly presented the proposal to import and market Mirikizumab Injection 300mg/15mL solution in vial and 100mg/mL solution in PFS indicated for the treatment of moderate to severe active ulcerative colitis in adults based on the results of global clinical trials conducted by the firm including the Indian population.

The committee noted that the drug is approved in USA, Europe, Canada, Japan, Australia and other countries.

Mirikizumab is a monoclonal antibody directed against the p19 subunit of human interleukin-23 (IL-23). The binding of mirikizumab to its target inhibits the interaction between IL-23 and the IL-23 receptor, thereby normalizing the overproduction of effector cytokines driving the pathogenesis of inflammatory diseases, including ulcerative colitis.

Mirikizumab is an anti-IL-23 monoclonal antibody used as a second-line therapy for moderate-to-severe active ulcerative colitis.

Mirikizumab-mrkz injection is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults.

At the recent SEC meeting for Gastroenterology and Hepatology held on 13th March 2024, the expert panel reviewed the proposal presented by Eli Lilly to import and market Mirikizumab Injection 300mg/15mL solution in vial and 100mg/mL solution in PFS indicated for the treatment of moderate to severe active ulcerative colitis in adults based on the results of global clinical trials conducted by the firm including the Indian population.

After detailed deliberation, the committee recommended a grant of marketing authorization to the firm for Mirkizumab Injection 300mg/15mL solution in vial and 100mg/mL solution in PFS subject to the condition that the firm should conduct Phase IV clinical trial in the country.

Accordingly, the expert panel suggested that the firm should submit a Phase IV clinical trial protocol to CDSCO within 3 months of marketing approval.

Also Read: CDSCO Panel grants Novo Nordisk’s Protocol Amendment Proposal For Antidiabetic Drug Semaglutide study

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NCDRC Grants Rs 9.77 Crore Relief to Surgeons, says MBBS doctors can perform Hair Transplant Procedures:

New Delhi: Holding that there was no medical negligence during the hair transplant procedure, the National Consumer Disputes Redressal Commission (NCDRC) recently exonerated a Hyderabad-based Hair Transplant Clinic and its two surgeons, who were sued by the patient for a compensation of Rs 9,77,15,000.

Although the patient challenged the qualifications of the doctors to conduct the hair transplant procedure, the top consumer court held that a person having an MBBS degree can perform the procedure of hair transplant, in which vital organs of the body are not affected.

Relying on the observations made by the Supreme Court in the case of Jacob Mathew v. State of Punjab, where the top court had clarified what constitutes medical negligence, the Apex Consumer Court dismissed the complaint.

The matter goes back to 2016 when the 60-year-old patient/complainant consulted the concerned Hair Transplant clinic with complaints of his receding hairline and baldness. After paying the advance amount, the doctors conducted tests. It was alleged that even though the blood sugar level of the patient was on the higher side, the doctors commenced the procedure on 25.07.2016 without controlling the blood sugar.

It was also alleged that the operation theatre was in appalling condition, poorly managed, unhygienic, and lacking the necessary infrastructure as required per medical science for procedure of the hair transplant. Allegedly, there was neither any arrangement to tackle the eventuality of a medical emergency nor it was equipped with any life-saving equipment.

Although the doctors started the procedure and implanted 2800 grafts to make hair grow from the tissues out of 3500 grafts, the patient developed an adverse reaction due to which the doctors discontinued the procedure and discharged the complainant saying that the remaining grafting would be done 4 days later.

Meanwhile, the patient developed unabated pain and discomfort on the scalp, swelling in head and face, discolouration of skin, and blisters on forehead and scalp. When he approached the treating centre, one of the two doctors allegedly opened the wound without even sanitizing his hand and burst the blisters by pinching through a figure at the reception counter. Referring to this, the patient argued that opening the wounds unhygienically, and unprofessionally that too at the reception counter was against Standard Medical Protocol and amounted to sheer negligence.

Further, it was alleged that the doctors did not make any investigations to find out the real issue of severe body reaction and committed grave negligence in this manner. Allegedly, the oedema soon extended from face to neck, resulting into a choking throat and it became difficult for the patient to consume even liquid.

Thereafter, the patient approached another hospital, where he remained admitted in the Emergency Ward due to a serious condition and was put into the Life Support System. The investigation at the second Hospital revealed (a) Facial Oedema including scalp extending to the neck; and (b) Bluish discolouration with Blebs. At this hospital, the patient  was under the treatment of various specialists. After treatment, the complainant got discharged from the hospital on 12.09.2016 and had to spend a lot for treatment.

The patient alleged that even though he survived he became disabled and lost his immune system from his body. He lost his right eye completely together with the skin from face to scalp. It was submitted that he was still under the medical supervision of various doctors and specialists attending him at home to monitor his health. Further, he claimed that the attending doctors have suggested more surgeries in the future to repair the damage caused to him. Therefore, filing the consumer complaint, the patient demanded around Rs 9.8 crore compensation from the Hair Transplant Centre and its two doctors.

On the other hand, the clinic and the doctors denied all charges of negligence and the doctors also referred to their qualification to argue that they were fully qualified to conduct the procedure. It was further submitted that the patient had been explained about the procedure, side effects and risks involved in such treatment.

They also claimed that the patient did not reveal the fact that he was dependent on the drugs for diabetes mellitus-II and hypertension. After finding his blood sugar level just above normal, he was advised to discuss about the dose of medication with his physician and the repeat blood sugar test revealed that the sugar level was within limit.

The clinic and its doctors claimed that the hair transplant procedure was conducted with full care and caution and by adopting Standard Medical Protocol. They claimed that the patient was discharged in good condition with proper dressing and he had been advised to check blood sugar levels twice a day in case the blood sugar level went 150/100 mg/dl, he was asked to consult with his physician.

It was further submitted by the clinic and its doctors that the maximum limit of extraction of graft in one session is 3000 grafts and therefore the procedure used to be done in two sessions i.e. one major session and other minor session after 3-4 days. Therefore, they denied that the transplant was discontinued after 2800 grafts and also the allegation that the complainant had developed reaction.

Further allegations that there was discolouration on the complainant’s forehead, that the doctor burst the blisters through hand on the reception counter etc were denied. It was submitted that the doctor removed the dressing in the proper dressing room under total aseptic precautions and while putting on a sterile surgical cap and at that time there was no blister.

When the complainant’s brother informed about discolouration on the forehead, the doctor expected the possibility of infection and advised to bring the patient at the centre. The doctor rushed to the complainant’s house and asked for blood sugar checking apparatus to check the blood sugar level. However, since there was no such apparatus when the complainant’s wife showed a recent report showing the RBS level 220 mg/dl, the doctor advised for immediate hospitalization. 

The clinic and its doctors submitted that the patient suffered from Necrotising Fasciitis, which happens in rare to rare case. In hair transplantation procedure, Necrotising Fasciitis disease is very rare and rarely happens in a common and healthy person except in persons whose immunity is less due to comorbidities like diabetes mellitus. Further, they pointed out that the doctor diagnosed his disease in time and referred him to a proper hospital.

Meanwhile, the NCDRC bench in its order dated 13.07.2017 had called for an expert opinion from All India Institute of Medical Sciences, New Delhi (AIIMS) and an Expert Committee was constituted. The panel, after examining the papers, opined in its meeting that the blood test report before the procedure showed RBS 160 mg/dl and the Acucheck value the next day showed RBS 105 mg/dl. The panel opined that this was an elective procedure for a nonurgent indication and pre-operative work-up for assessment and control of diseases of the patient should have been performed more rigorously by the doctor.

“Had the doctor been more proactive at this point, condition would have been better. Immediate hospitalization on 26.07.2016 in evening could have improved the outcome,” the panel further observed. However, due to the lack of documents, the board was unable to comment on intraoperative component of the hair transplant procedure, which may have influenced the postoperative complications, particularly since complications arose within 24 hours of the procedure.

While considering the matter, the top consumer court noted that the patient challenged the qualifications of the two doctors for conducting the hair transplant procedure. Against this, the doctors submitted documents to prove their qualifications.

NCDRC noted that even though Telangana State Medical Council in its order dated 10.01.2018 found that the degrees and certificates relating to hair transplant of the doctors were not from any recognised institution, both the doctors were MBBS and duly enrolled with the Medical Council.

At this outset, the NCDRC bench observed,

“Hair transplant is a surgical technique that removed hair follicles from one part of body to another balding part of body. In this procedure vital organs of the body are not affected. Dermis is in syllabus of study of M.B.B.S. course. A person having MBBS degree can perform the procedure of hair transplant. Board of Governors, In Supersession of Medical Council of India, in its dated 11.01.2019, did not find lack of qualification. OP-1 had qualification and experience of minor surgery, therefore he was competent for hair transplant on 25.07.2016.”

Regarding the allegation that the operation theatre was in unhygienic condition, the Commission noted that the complainant did not file any application for local inspection and therefore it could not be said that the operation theatre was not maintained properly.

Referring to the allegation that the procedure was conducted without controlling the blood sugar levels, the NCDRC bench noted,

“OP-1 (doctor) proceeded with the procedure of hair transplant on 25.07.2016, when the blood sugar was within normal range then at the most, it was an error of judgment not negligence.”

“A perusal of ‘Operate Note’ shows that the procedure for hair transplant was started at 9:00 hours and after transplant of 2800 grafts his condition was checked up 15:00 hours. Figure of transplant of 2800 grafts is admitted to the complainant. This figure shows that it was a targeted figure and not that transplant was stopped due to reaction. Medical check-up shows that his condition was normal. ‘Operate Note’ shows that he was discharged in good general condition at 15:15 hours with special instruction for diabetes and hypertension control,” it further noted.

NCDRC also observed that the complainant had admitted before Telangana State Medical Council that there was oedema on face and fever and no discolouration on his forehead in the morning after the procedure. It also perused the “Operation Note” dated 26.07.2016 that mentioned that the patient “came for dressing removal. C/O pain. Dressing removed. Donor and transplant area healing well, and dry. Oedema on forehead present. Expected. Enquired about blood sugar level. Attender said, it was normal. Discharged home in good general condition & sterile surgical cap. Cap. Sporidex-500 T D added.”

Further, the top consumer court also took note of a photo filed by both the patient, the clinic and doctors. “In this photo, the complainant was bearing sterile surgical cap and he had oedema on the face and eyes. In this photo, no mark of blister on forehead appears as such allegation that in morning on 26.07.2016 blisters appeared on the forehead, before removal of dressing, is not proved. Allegation of the complainant that due to serious and abnormal condition, he visited to the centre on 26.07.2016 in morning does not appear to be correct rather his visit for removal of the bandage appears more probable,” noted the Commission.

“On 26.07.2016 at 11:00 hours, when the complainant visited the OPs for removal of dressing, there was oedema on the face and eyes, with pain and temperature which was normal reaction and symptoms after hair transplant. From these symptoms, it is not expected that the OPs would have diagnosed ‘Necrotising Fasciitis’ on 26.07.2016 at 11:00 hours, which was rare complication in hair transplant and got the complainant admitted in the hospital. As soon as, OP-1 was informed about serious symptoms on 26.07.2016 in evening, he visited the house of the complainant and advised for immediate hospitalization,” it further observed.

The Commission opined that there are various sources of infection of the bacteria of ‘Necrotising Fasciitis’. It also opined that the subsequent suffering of the complainant was due to his being a diabetes patient as at the time of his admission at the second hospital, his Random Blood Sugar level was found 469 mg/dl.

Therefore, dismissing the complaint, the top consumer court noted, “Thus medical negligence is not proved. Medical Council of India has considered all the aspects and found that there was no negligence on the part of the OPs as alleged.”

To view the order, click on the link below:

https://medicaldialogues.in/pdf_upload/ncdrc-hair-transplant-235791.pdf

Also Read: Mushrooming hair transplant centers: Court orders National Level Protocol for Doctors performing Hair Transplantation, Aesthetic Surgeries

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Odisha Govt lays down stringent measures to curb fake doctors menace

Cuttack: In a significant move aimed at ensuring the safety and well-being of citizens, the Odisha government has decided to establish anti-quack cells in all districts. The government has pledged to eliminate the presence of quacks, across the state.  

Responding to the Orissa High Court, the government has outlined a series of measures to crack down on this menace. One of the key initiatives announced by the state government is the establishment of anti-quack cells in all districts and these cells will serve as dedicated units to investigate complaints and take swift action against individuals practising medicine without proper qualifications. Upon receiving reports of fake doctors, the authorities will promptly register complaints at police stations and initiate arrests, reports Prameyanews.

Also Read:Odisha: Quack caught red handed in Gynaecology dept of District Headquarters Hospital

Furthermore, the government has taken steps to enhance transparency in the medical profession by uploading the names of registered doctors on the website of the Odisha Council of Medical Registration. This online database will provide easy access to information about legitimate healthcare practitioners, enabling the public to verify the credentials of doctors practising in their locality. 

Recognizing the importance of spreading awareness among the rural population, the government plans to disseminate information about registered doctors in panchayats and rural areas. Local public representatives will play a crucial role in this endeavour by ensuring that communities are informed about the availability of authentic medical services, reports The Daily.

To facilitate accessibility to this vital information, the government has introduced the Sanjog toll-free helpline number 1916. Individuals who cannot access the online database can call this helpline to inquire about the legitimacy of a particular doctor. These initiatives come in response to directives from the Orissa High Court, which had urged the state health department to take proactive measures to identify and eliminate fake doctors.

With these stringent measures in place, the Odisha government is committed to safeguarding the health and well-being of its citizens by ensuring that only qualified and registered medical professionals provide healthcare services across the state. 

Also Read:Bhubaneshwar Doctor Couple murder case: 5 persons sentenced to life imprisonment

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Amritsar doctor arrested in case of cheating, forgery for death of patient in 2018

Amritsar: A city-based doctor from a private hospital located in the posh Ranjit Avenue area has been recently arrested on charges of cheating and forgery related to a case of alleged post-operative negligence resulting in a patient’s death. 

The complainant in this case, Gokul Chand Aneja accused the doctor and the hospital staff of gross negligence in the post-operative care of his wife, leading to her untimely death in October 2018. A resident of the Airport Road area, Aneja filed complaints in 2021, sparking a two-year police investigation into the 3 years old alleged cheating and forgery case. 

Following the complaint, the doctor and the private hospital were booked under Sections 420 (cheating), 465 (forgery), 468 (forgery for cheating), and 471 (using as genuine a forged document or electronic record) of the Indian Penal Code (IPC).

Also read- Punjab: Medical Officer, Nurse Booked Under IPC 304A For Death Of Woman Post Delivery

After his arrest, the state health authorities led by Assistant Civil Surgeon Dr Rajinderpal Kaur raided her private hospital and seized records of surgeries, CCTV footage and accounts of financial transactions of the hospital on April 5. 

This raid was conducted based on a complaint from Gokul Chand Aneja who gave a tip-off to the health department that the accused was practising medicine despite his license being suspended by the Punjab Medical Council (PMC) and handed over an application to the district administration and Assistant Civil Surgeon Dr Rajinderpal Kaur in this connection.

The accused license was revoked after the complainant, Aneja submitted a complaint to the Health Department for a high-level probe into the alleged negligence case. A medical board, constituted by the Civil Surgeon, investigated the case and found evidence of tampering with attendance records, false claims of doctor presence in the ICU recovery room, and forged signatures in the hospital treatment file.

In response to the probe report, the PMC suspended the doctor’s registration for six months and debarred him from practice due to alleged negligence towards patients as reported by The Tribune.

In the order, the PMC pointed out that “all the council members unanimously decided that Dr Parveen Devgan failed to demonstrate due skills and care towards the patients and it decides to suspend his registration for six months and debar him from practice during the period.” 

The council further stated that the duration may be prolonged in case the accused does not meet the requirements of providing a root cause analysis regarding the patient’s death and a laparoscopic hysterectomy training certificate from an accredited institution.

Additionally, it was mentioned that the accused performed surgery on another patient, following the incident, in addition to his wife Sunita. Unfortunately, she also experienced comparable complications post-surgery and eventually passed away.

Later, the complainant urged the police to add Section 304 (death by negligence) of the IPC against him and his other staff members to the FIR and the accused was arrested in connection with this case on Thursday, three years after the initial complaint.

He was produced in a court recently which remanded him in judicial custody. Meanwhile, the police have instructed the PMC to revoke her license as they continue to investigate the case of criminal negligence.

Also read- Woman Dies After Gallbladder Surgery, Doctor Booked Under IPC 304A

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