Collagen patch cover applied to anastomotic site after laparoscopic colectomy may facilitate recovery of bowel function: Study

Collagen patch cover applied to anastomotic site after laparoscopic colectomy may facilitate recovery of bowel function suggests a new study published in the BMC Surgery.

Numerous factors can influence bowel movement recovery and anastomotic healing in colorectal surgery, and poor healing can lead to severe complications and increased medical expenses. Collagen patch cover (CPC) is a promising biomaterial that has been demonstrated to be safe in animal models and has been successfully applied in various surgical procedures in humans. This study. A retrospective review of medical records from July 2020 to June 2022 was conducted to identify consecutive patients who underwent laparoscopic colectomy. Patients who received CPC at the anastomotic site were assigned to the collagen group, whereas those who did not receive CPC were assigned to the control group. Results: Data from 241 patients (collagen group, 109; control group, 132) were analyzed. Relative to the control group, the collagen group exhibited a faster recovery of bowel function, including an earlier onset of first flatus (2.93 days vs. 3.43 days, p < 0.01), first defecation (3.73 days vs. 4.18 days, p = 0.01), and oral intake (4.30 days vs. 4.68 days, p = 0.04). CPC use was also associated with lower use of postoperative intravenous analgesics. The complication rates in the two groups did not differ significantly. CPCs can be safely and easily applied to the anastomotic site during laparoscopic colectomy, and can accelerate bowel movement recovery. Further studies on the effectiveness of CPCs in colorectal surgery involving larger sample sizes are required.

Reference:

Huang, PY., Tsai, MC., Kiu, KT. et al. Collagen patch cover facilitates recovery of bowel function after laparoscopic colectomy. BMC Surg 24, 66 (2024). https://doi.org/10.1186/s12893-024-02339-w

Keywords:

Collagen patch, cover, anastomotic site, laparoscopic colectomy, recovery, bowel function, BMC Surgery, Huang, PY., Tsai, MC., Kiu, K

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Simple hysterectomy non-inferior to radical hysterectomy for pelvic recurrence in women with low-risk cervical cancer: NEJM

Canada: A recent study published in the New England Journal of Medicine compared simple versus radical hysterectomy in women with low-risk cervical cancer.

The researchers found simple hysterectomy to be not inferior to radical hysterectomy concerning the 3-year incidence of pelvic recurrence in patients with low-risk cervical cancer. A simple hysterectomy was linked with a reduced risk of urinary incontinence or retention.

Retrospective data indicate that parametrial infiltration incidence is low in women with early-stage low-risk cervical cancer, which raises questions regarding the need for radical hysterectomy in these patients. However, there is a lack of data from large, randomized trials comparing outcomes of radical and simple hysterectomy.

To fill this knowledge gap, Marie Plante, the University of British Columbia, Vancouver, Canada, and colleagues conducted a multicenter, randomized, noninferiority trial comparing radical hysterectomy with simple hysterectomy including lymph-node assessment in patients with low-risk cervical cancer (lesions of ≤2 cm with limited stromal invasion).

The study’s primary outcome was cancer recurrence in the pelvic area (pelvic recurrence) at three years. The prespecified noninferiority margin for the between-group difference in pelvic recurrence at three years was 4 percentage points.

Based on the study, the researchers reported the following findings:

  • Among 700 patients who underwent randomization (350 in each group), the majority had tumours that were stage IB1 according to the 2009 International Federation of Gynecology and Obstetrics (FIGO) criteria (91.7%), that had squamous-cell histologic features (61.7%), and that were grade 1 or 2 (59.3%).
  • With a median follow-up time of 4.5 years, the incidence of pelvic recurrence at 3 years was 2.17% in the radical hysterectomy group and 2.52% in the simple hysterectomy group. Results were similar in a per-protocol analysis.
  • The incidence of urinary incontinence was lower in the simple hysterectomy group than in the radical hysterectomy group within 4 weeks after surgery (2.4% vs. 5.5%) and beyond 4 weeks (4.7% vs. 11.0%).
  • The incidence of urinary retention in the simple hysterectomy group was also lower than that in the radical hysterectomy group within 4 weeks after surgery (0.6% vs. 11.0%) and beyond 4 weeks (0.6% vs. 9.9%).

“In patients with low-risk cervical cancer, simple hysterectomy was not inferior to radical hysterectomy concerning the 3-year incidence of pelvic recurrence and was linked with a lower risk of urinary incontinence or retention,” the researchers wrote.

“The study findings challenge our current standards and provide evidence that in selected patients, simple hysterectomy appears to be safe, yielding oncologic outcomes similar to those of radical hysterectomy, but due to the specificity of the disease and patient factors certain points require additional analysis,” Pedro T. Ramirez, MD, chair of the department of obstetrics and gynaecology at Houston Methodist Hospital, wrote in an accompanying editorial.

He added, “It is critical to ensure that simple hysterectomy use is limited to patients having low-risk tumours and meeting the eligibility criteria for this conservative approach. Patients who do not meet such inclusion criteria should continue to be offered radical hysterectomy.”

Reference:

Plante M, Kwon JS, Ferguson S, Samouëlian V, Ferron G, Maulard A, de Kroon C, Van Driel W, Tidy J, Williamson K, Mahner S, Kommoss S, Goffin F, Tamussino K, Eyjólfsdóttir B, Kim JW, Gleeson N, Brotto L, Tu D, Shepherd LE; CX.5 SHAPE investigators; CX.5 SHAPE Investigators. Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer. N Engl J Med. 2024 Feb 29;390(9):819-829. doi: 10.1056/NEJMoa2308900. PMID: 38416430.

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Spontaneous breathing trial techniques: Pressure support tied to more successful extubations compared with T-piece, study finds

Canada: A systematic review and meta-analysis comprising 6716 critically ill adults and children suggested that pressure support (versus T-piece) spontaneous breathing trials (SBTs) are linked with more successful extubations without increasing the risk of reintubation.

“Patients undergoing pressure support compared with T-piece SBTs were more likely to be extubated successfully and more likely to pass a spontaneous breathing trial if the results of an outlier trial were excluded,” the researchers reported in their study published in JAMA Network Open.

About 40% of the time spent on mechanical ventilation is attributed to the weaning process. A randomized clinical trial and a systematic review suggested that weaning protocols shorten the length of stay (LOS) in intensive care units (ICUs), the weaning time, and the duration of mechanical ventilation. Patients typically undergo a spontaneous breathing trial to assess their capacity to breathe spontaneously with little or no support.

Spontaneous breathing trials aid clinicians in minimizing the invasive ventilation duration for patients and stimulate timely discussion regarding readiness for extubation.

Several techniques are commonly used to conduct SBTs, such as continuous positive airway pressure (CPAP), T-piece, automatic tube compensation (ATC; providing flow-dependent ventilator support to overcome the resistance of the endotracheal tube during inspiration and expiration), pressure support (PS) with or without positive end-expiratory pressure (PEEP), and more recently, high-flow oxygen (HFO; offering variable levels of CPAP depending on the flow rate used). However, considerable controversy exists regarding the best spontaneous breathing trial technique to use.

Against the above background, Karen E. A. Burns, Department of Critical Care, St. Michael’s Hospital, Unity Health Toronto, Toronto, Ontario, Canada, and colleagues aimed to summarize trials comparing alternative SBTs.

For this purpose, the researchers searched several online databases from inception to 2023 and 5 conference proceedings (from January 1990 to April 2023). They selected randomized trials directly comparing SBT techniques in critically ill adults or children and reporting at least 1 clinical outcome.

Paired reviewers independently screened citations, abstracted data and assessed quality for the systematic review and meta-analysis using PRISMA guidelines. Data pooling was done using random-effects models. The systematic review and meta-analysis identified 40 trials that included 6716 patients.

Primary outcomes were SBT success, extubation success, and reintubation.

The researchers reported the following findings:

  • Low-quality evidence (14 trials [n = 4459]) suggested that patients were not more likely to pass pressure support (PS) compared with a T-piece SBT (risk ratio [RR], 1.04), unless 1 outlier trial accounting for all heterogeneity was excluded (RR, 1.09 [13 trials; n = 3939]; moderate-quality evidence), but were significantly more likely to be successfully extubated (RR, 1.07; 16 trials [n = 4462]; moderate-quality evidence).
  • Limited data (5 trials [n = 502]) revealed that patients who underwent automatic tube compensation/continuous positive airway pressure compared with PS SBTs had a significantly higher successful extubation rate (RR, 1.10 [low-quality evidence]).
  • Compared with T-piece SBTs, high-flow oxygen SBTs (3 trials [n = 386]) had significantly higher successful extubation (RR, 1.06) and lower reintubation (RR, 0.37 [both low-quality evidence]) rates. Credible subgroup effects were not found.

“These findings suggest that critically ill adults or children undergoing pressure support compared with T-piece SBTs were more likely to pass an SBT and to be extubated successfully,” the researchers wrote. “Pressure support SBTs were not linked with an increased risk of reintubation.”

“Future investigations should include these findings and compare SBT techniques that maximize differences in inspiratory support,” they concluded.

Reference:

Burns KEA, Khan J, Phoophiboon V, et al. Spontaneous Breathing Trial Techniques for Extubating Adults and Children Who Are Critically Ill: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2024;7(2):e2356794. doi:10.1001/jamanetworkopen.2023.56794

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Eli Lilly gets CDSCO Panel Nod to Import, Market Antidiabetic Drug Tirzepatide solution for injection Single dose vial

New Delhi: The drug major Eli Lilly has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to import and market the antidiabetic drug Tirzepatide 2.5 mg/0.5 ml, 5mg/0.5ml, 10mg/0.5 ml, 12.5 mg/0.5 ml and 15mg/.5 ml solution for injection (single dose vial).

However, this approval is subject to the condition that the firm should conduct a Phase IV clinical trial and be required to submit the Phase IV clinical trial protocol to CDSCO within 03 months from the date of approval.

This came after the drug maker Eli Lilly presented the proposal for import and marketing permission of Tirzepatide 2.5 mg/0.5 ml, 5mg/0.5ml, 10mg/0.5 ml, 12.5 mg/0.5 ml and 15mg/.5 ml solution for injection (Single dose vial) along with their justification for bioequivalence (BE) and clinical trial (CT) waiver before the committee.

The firm informed that a similar formulation i.e Tirzepatide 2.5 mg/0.5 ml, 5mg/0.5ml, 10mg/0.5 ml, 12.5 mg/0.5 ml, and 15mg/.5 ml injection in the prefilled pen is already approved by the CDSCO for the same indication and now the firm has proposed for formulation in a single-dose vial presentation.

Tirzepatide is a dual GIP and GLP-1 receptor agonist used for the treatment of type II diabetes in adults as an adjunct to diet and exercise.

Tirzepatide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus or for chronic weight management for adult patients that are obese or overweight with at least one weight-related comorbid condition such as hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease).

Tirzepatide is a peptide molecule that acts as a dual agonist at GLP-1 and GIP receptors. It enhances the insulin response, suppresses glucagon secretion, promotes satiety, and improves insulin sensitivity.

At the recent SEC meeting for Endocrinology and Metabolism held on 13th and 14th February 2023, the expert panel reviewed the proposal for import and marketing permission of Tirzepatide along with their justification for BE and CT waiver.

After detailed deliberation, the committee recommended the import and marketing permission of Tirzepatide 2.5 mg/0.5 ml, 5mg/0.5ml, 10mg/0.5 ml, 12.5 mg/0.5 ml, and 15mg/.5 ml solution for injection (single dose vial) subject to the condition that the firm should conduct Phase-IV clinical trial.

Accordingly, the expert panel suggested that the firm should submit a Phase-IV clinical trial protocol to CDSCO within 03 months from the date of approval for further review by the committee.

Furthermore, the committee opined that the firm should fulfill the requirement of chemistry, manufacturing, and controls (CMC) data along with comparative data with that of the already approved pre-filled pen.

Also Read:Glenmark Gets CDSCO Panel Nod to Study ISB 2001 in Multiple Myeloma

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Quick Review of Adult Vaccines with Dr Anantha Padmanabha

In this video Dr. Anantha Padmanabha talks about range of diseases and their corresponding vaccines crucial for adult health maintenance.
From preventing the debilitating effects of dengue and chickenpox to combating the life-threatening risks posed by malaria, meningitis, influenza, COVID-19, and pneumococcal infections, he sheds light on the significance of vaccination in safeguarding against various infectious diseases.
Furthermore he addresses the current landscape of vaccine availability, particularly highlighting the unavailability of dengue vaccines in India, underscoring the challenges and gaps in vaccine accessibility.
Dr. Padmanabha offers insights into the latest recommendations regarding vaccine administration, including booster doses to bolster waning immunity or enhance protection against emerging variants.
By staying aware of evolving vaccine guidelines and dosage recommendations, viewers can make informed decisions regarding their vaccination schedules, ensuring comprehensive immunity against a spectrum of infectious diseases.

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Doctor allegedly leaves cotton swab inside woman during caesarean delivery, booked

A doctor from a government hospital in Jambusar, Bharuch district, was booked for allegedly leaving a cotton swab inside a woman during a caesarean delivery last September. The woman, Amisha Solanki, underwent surgery at the sub-district hospital in Jambusar, operated by Dr. Charmi Ahir, where she gave birth to a boy. However, after discharge, she experienced stomach pain, leading to further medical consultations.

Tests at a diagnostic center revealed the presence of a cotton swab i, her abdomen. Despite informing Dr. Ahir about the issue, the situation reportedly did not improve. Eventually, the swab was removed through surgery at Yashoda Hospital in Surat on November 28, after the couple’s repeated attempts to resolve the matter.

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