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Evaluation of Gasless Laparoscopy as a Tool for Minimal Access Surgery in Low- to Middle-Income Countries: A Phase II Non-Inferiority Randomized Controlled Study.

ABSTRACT: BACKGROUND:Minimal access surgery [MAS] is not available to most people in the rural areas of Low Middle-Income Countries [LMIC]. This leads to an increase in the morbidity and the economic loss to the poor and the marginalized. The Gasless laparoscopic surgeries [GAL] are possible in rural areas as they could be carried out under spinal-anaesthesia. In most cases, it does not require the logistics of providing gases for pneumoperitoneum and general anaesthesia. The current study compares GAL with conventional Laparoscopic surgeries [COL] for general surgical procedures METHODS: A single-centre, non-blinded randomized control trial [RCT] was conducted to evaluate non - inferiority of GAL versus COL at a teaching hospital in New Delhi. Patients were allocated into two groups and underwent MAS (Cholecystectomies and appendectomies). The procedure was carried out by two surgeons by randomly choosing between GAL and COL. The data was collected by postgraduates and analyzed by a biostatistician. RESULTS:100 patients who met the inclusion criteria were allocated into two groups. No significant difference was observed in the mean operating time between GAL group (52.9 min) vs COL group (55 minutes) [p=0.3]. The intraoperative vital signs were better in the GAL group [p < 0.05]. The postoperative pain score was slightly higher in the GAL group [p = 0.01]; however, it did not require additional analgesics. CONCLUSIONS:No significant differences were found between the two groups. GAL can be classed as non-inferior compared to COL and has the potential to be adopted in low resource settings.

SUBMITTER: Mishra A

PROVIDER: S-EPMC7435287 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Evaluation of Gasless Laparoscopy as a Tool for Minimal Access Surgery in Low-to Middle-Income Countries: A Phase II Noninferiority Randomized Controlled Study.

Mishra Anurag A Bains Lovenish L Jesudin Gnanaraj G Aruparayil Noel N Singh Rajdeep R Shashi

Journal of the American College of Surgeons 20200819 5

<h4>Background</h4>Minimal access surgery is not available to most people in rural areas of low-to middle-income countries. This leads to an increase in morbidity and economic loss to the poor and marginalized. Gasless laparoscopic (GAL) procedures are possible in rural areas because they can be performed under spinal anesthesia. In most cases, it does not require the logistics of providing gases for pneumoperitoneum and general anesthesia. The current study compares GAL with conventional laparo ...[more]

PMID: 32827645

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Project description:ImportanceGastrointestinal stromal tumor (GIST) is a rare cancer treated with the tyrosine kinase inhibitors imatinib mesylate or sunitinib malate. In general, in low- and middle-income countries (LMICs), access to these treatments is limited.ObjectiveTo describe the demographic characteristics, treatment duration, and survival of patients with GIST in LMICs treated with imatinib and sunitinib through The Max Foundation programs.Design, setting, and participantsThis retrospective database cohort analysis included patients in 2 access programs administered by The Max Foundation: the Glivec International Patient Assistance Program (GIPAP), from January 1, 2001, to December 31, 2016, and the Max Access Solutions (MAS) program, January 1, 2017, to October 12, 2020. Sixty-six countries in which The Max Foundation facilitates access to imatinib and sunitinib were included. Participants consisted of patients with approved indications for imatinib, including adjuvant therapy in high-risk GIST by pathologic evaluation of resected tumor or biopsy-proven unresectable or metastatic GIST. All patients were reported to have tumors positive for CD117(c-kit) by treating physicians. A total of 9866 patients received treatment for metastatic and/or unresectable disease; 2100 received adjuvant imatinib; 49 received imatinib from another source and were only included in the sunitinib analysis; and 53 received both imatinib and sunitinib through The Max Foundation programs. Data were analyzed from October 13, 2020, to January 30, 2024.Main outcomes and measuresDemographic and clinical information was reported by treating physicians. Kaplan-Meier analysis was used to estimate time to treatment discontinuation (TTD) and overall survival (OS). An imputation-based informed censoring model estimated events for patients lost to follow-up after treatment with adjuvant imatinib. Patients who were lost to follow-up with metastatic or unresectable disease were presumed deceased.ResultsA total of 12 015 unique patients were included in the analysis (6890 male [57.6%]; median age, 54 [range, 0-100] years). Of these, 2100 patients were treated with imatinib in the adjuvant setting (median age, 54 [range 8-88] years) and 9866 were treated with imatinib for metastatic or unresectable disease (median age, 55 [range, 0-100] years). Male patients comprised 5867 of 9866 patients (59.5%) with metastatic or unresectable disease and 1023 of 2100 patients (48.7%) receiving adjuvant therapy. The median OS with imatinib for unresectable or metastatic disease was 5.8 (95% CI, 5.6-6.1) years, and the median TTD was 4.2 (95% CI, 4.1-4.4) years. The median OS with sunitinib for patients with metastatic or unresectable GIST was 2.0 (95% CI, 1.5-2.5) years; the median TTD was 1.5 (95% CI, 1.0-2.1) years. The 10-year OS rate in the adjuvant setting was 73.8% (95% CI, 67.2%-81.1%).Conclusions and relevanceIn this cohort study of patients with GIST who were predominantly from LMICs and received orally administered therapy through the GIPAP or MAS programs, outcomes were similar to those observed in high-resource countries. These findings underscore the feasibility and relevance of administering oral anticancer therapy to a molecularly defined population in LMICs, addressing a critical gap in cancer care.

Project description:BackgroundAntimicrobial misuse is common in low-income and middle-income countries (LMICs), and this practice is a driver of antibiotic resistance. We compared community-based antibiotic access and use practices across communities in LMICs to identify contextually specific targets for interventions to improve antibiotic use practices.MethodsWe did quantitative and qualitative assessments of antibiotic access and use in six LMICs across Africa (Mozambique, Ghana, and South Africa) and Asia (Bangladesh, Vietnam, and Thailand) over a 2·5-year study period (July 1, 2016-Dec 31, 2018). We did quantitative assessments of community antibiotic access and use through supplier mapping, customer exit interviews, and household surveys. These quantitative assessments were triangulated with qualitative drug supplier and consumer interviews and discussions.FindingsVietnam and Bangladesh had the largest proportions of non-licensed antibiotic dispensing points. For mild illness, drug stores were the most common point of contact when seeking antibiotics in most countries, except South Africa and Mozambique, where public facilities were most common. Self-medication with antibiotics was found to be widespread in Vietnam (55·2% of antibiotics dispensed without prescription), Bangladesh (45·7%), and Ghana (36·1%), but less so in Mozambique (8·0%), South Africa (1·2%), and Thailand (3·9%). Self-medication was considered to be less time consuming, cheaper, and overall, more convenient than accessing them through health-care facilities. Factors determining where treatment was sought often involved relevant policies, trust in the supplier and the drug, disease severity, and whether the antibiotic was intended for a child. Confusion regarding how to identify oral antibiotics was revealed in both Africa and Asia.InterpretationContextual complexities and differences between countries with different incomes, policy frameworks, and cultural norms were revealed. These contextual differences render a single strategy inadequate and instead necessitate context-tailored, integrated intervention packages to improve antibiotic use in LMICs as part of global efforts to combat antibiotic resistance.FundingWellcome Trust and Volkswagen Foundation.

Project description:Currently, more than five times more people live in low- and middle-income countries (LMICs) than in high-income countries (HICs). As such, the downward trend in cardiac surgical needs in HICs reflects only the situation of one sixth of the world population while the vast majority living in LMICs has still no or limited access to life saving heart operations. In these countries, rheumatic heart disease (RHD) still accounts for a significant proportion of cardiac surgical needs. In low- and lower-middle income countries it remains the single most common cardiovascular disease in young adult and adolescent patients in need of heart surgery outweighing other indications such as congenital cardiac defects almost 4-fold. Compared to HICs with their predominance of calcific aortic stenosis in the elderly mitral valve surgery is required in >90% of the largely young patients with RHD in low-income countries (LICs) and still in 70% of the often middle aged patients in middle-income countries (MICs). Although recent government initiatives in LICs led to the establishment of local, independent cardiac surgical services gradually replacing fly-in missions, these centers still only cover less than 2% of the needs of their populations. In MICs, cardiac surgical needs continually grow with the emergence of degenerative diseases. As such, in spite of the concomitant growth of cardiac surgical capacity, significantly less than half the estimated patients in need have access. Capacities in LICs range from 0.5 to 7 cardiac operations/million population; 100-481/million in MICs and >1,200/million in HICs such as the USA and Germany. While a new level of awareness of the scope and magnitude of the problem has begun to emerge in LICs and the establishment of local cardiac surgical capacity has given rise to a glimpse of hope, the challenges of expanding these fledgling services to a significant proportion of the population still seem insurmountable. Challenges in MICs are on the other hand the widening gap between private cardiac medicine for the affluent few and overwhelmed public services for the many and the rural urban divide with the underappreciation of the ongoing dominance of RHD in the rural and indigent population on the other. Overshadowing all LMICs is the low level of valve-repair skills associated with insufficient cardiac surgical capacity and the unavailability of suitable replacement valves which address the young age of the patients and the difficulties of anticoagulation in a socioeconomic environment distinctly different from the elderly patients of HICs.

Dataset Information

Evaluation of Gasless Laparoscopy as a Tool for Minimal Access Surgery in Low- to Middle-Income Countries: A Phase II Non-Inferiority Randomized Controlled Study.

Publications

Evaluation of Gasless Laparoscopy as a Tool for Minimal Access Surgery in Low-to Middle-Income Countries: A Phase II Noninferiority Randomized Controlled Study.

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