Analysis Of The Impact Of Gills (gas Insufflation-less Laparoscopic Surgery) In The Selected Rural Hospitals In India.

The article “Global Surgery 2030: Evidence and solutions for achieving health, welfare, and economic development” by Meara and Greenberg, published by the Lancet Commission on Global Surgery, sets ambitious goals for global surgical care. It advocates for all nations to monitor surgical volume and aim to perform at least 5,000 procedures per 100,000 people annually by 2030. Highlighting the critical shortage of surgical services in low- and middle-income countries (LMICs), the report emphasizes the potential of basic surgical care to prevent significant morbidity and mortality. It calls for substantial investment in surgical and anesthesia resources to meet current and future demands, underscoring the economic and health benefits of such investments.[1]

In India, the Pradhan Mantri Jan Arogya Yojana (PMJAY) is a national health insurance program covering the poorest 40% of the population.[2] Despite its scope, the surgical rate remains low at 166 surgeries per 100,000 eligible beneficiaries, hindered by slow hospital empanelment, uneven care access, and low awareness among beneficiaries.[3] Universal health coverage (UHC) aims to ensure affordable, high-quality medical treatment for all, but incorporating surgical procedures into existing healthcare frameworks remains challenging despite the rising global demand. Gas-Less Laparoscopic Surgery (GILLS), have the potential to significantly improve surgical coverage in rural and underserved areas. GILLS, which does not require carbon dioxide insufflation, offers a practical solution for regions where conventional laparoscopic equipment might be impractical due to cost or infrastructure limitations[4]

In many rural and underprivileged areas of India, access to advanced surgical care remains limited.[5] Traditional laparoscopic surgeries are often impractical in rural areas due to high costs and specialized equipment needs.[6] To address these challenges, gas-less laparoscopic surgery has emerged as a promising alternative. This technique eliminates the need for gas insufflation, making it more feasible and cost-effective for rural settings.[4]

The TARGET Program

Many rural hospitals and clinics lacked the necessary equipment and trained personnel to perform advanced laparoscopic surgeries, which are less invasive and have quicker recovery times compared to traditional open surgeries.[7] Hence, in March 2019, the TARGET program was introduced at Kolkata Medical College to train surgeons in laparoscopic skills and gas-less procedures. Seven surgeons from rural northeastern states participated, and their hospitals were required to document all abdominal surgeries.[8] While laparoscopic surgery offers benefits like reduced infection rates and shorter recovery times, its adoption in LMICs is slow. [9]. Despite its potential benefit, GILLS faces obstacles in functionality, resilience, and the need for more comprehensive training. [10]The WHO emphasizes the importance of affordability, availability, accessibility, and appropriateness in medical device development to improve global access to healthcare technologies.[11]

The German Society for the Promotion of Surgery in Developing Countries (DTC), established in 1990, partnered with the Association of Rural Surgeons of India and the International Federation of Rural Surgeons to promote gasless laparoscopic surgeries in rural India and to study the impact of such a program using the Proctorship Method.

This study aims to determine if GILLS can reduce costs and infrastructure requirements, making laparoscopic surgery more accessible to underserved rural populations. By analyzing surgical volume data from February 2022 to February 2024, the study tests the hypothesis that GILLS increases surgical volumes in these hospitals. The methodology includes a comparative retrospective analysis using data from 17 hospitals with GILLS training and five control hospitals. The results will inform recommendations for improving surgical care and resource allocation in rural India.

The study’s main research question is: – “Analysis of the effects of GILLS (gas insufflation-less laparoscopic surgery) in the selected rural hospitals in India.”

Main goal of this research is to analyse the adoption of (GILLS) Gas Insufflation Less Laparoscopic surgery increases the surgical coverage rate.

Therefore, this study is intended to achieve the following objectives: –

• To record and analyse the surgical volume in the selected hospitals during the time period of Feb 2022 to Feb 2024 after empowering with GILLS in the selected hospitals. This data was gathered during the Proctorship program of the project by the visiting team in the standardized format and were compiled and sent to the German partner of the program.
• Compare the surgical volume data prior to empowering with GILLS during the same time period to identify the changes or trends
• To provide evidence-based insights into the potential benefits, challenges of adopting GILLS surgical technique in the selected hospitals of rural India.

Additionally, this study will investigate the possibility that the introduction of GILLS could lead to an increase in the surgical procedures. Hospitals may be able to perform a greater number of laparoscopic procedures if they adopt this technique

Hypothesis for the case hospitals (n=17) and hypothesis for control hospital (n= 5) will be tested to provide evidence-based insights into the potential benefits, challenges of adopting GILLS surgical technique in the selected hospitals of rural India.

Case Hospitals (n=17)

• H0: – Empowering with Gas Less Laparoscopic technique did not increase the surgical volume at the selected hospitals of rural India during Feb 2022 to Feb 2024
• H1: – Empowering with Gas Less laparoscopic technique increases the surgical volume at the selected hospital of rural India during Feb 2022 to Feb 2024.

Control Hospitals (n=5):

• H0: No significant difference in surgical volume two years before and after 2022.
• H1: Significant difference in surgical volume two years before and after 2022.

According to the findings of the investigation, it can be concluded that empowering with GILLS may have witness the higher surgical coverage and can be compared with the control hospital, there may have been a change in the kinds of surgical procedures that were carried out after the introduction of GILLS. It’s possible that hospitals will witness a rise in laparoscopic procedures while simultaneously experiencing a decline in open surgical procedures.

This study undertakes a comparative retrospective analysis to evaluate the significance of gas-less laparoscopic surgery in rural and underprivileged areas of India. Conducted from an Indian perspective, the investigation aims to assess the effects of gas insufflation-less laparoscopic surgical innovation through data gathered during a Partnership project in selected regions of India. Seventeen remote hospitals with trained and equipped surgeons using the Gas Insufflation-Less Laparoscopic Surgery (GILLS) technique, and for which surgical volume data is available, were identified for the study. Additionally, five control hospitals interested in starting GILLS but not yet initiated are included for comparison. The study documents the number of operations carried out before and after GILLS implementation.

Data collection spans from February 2022 to February 2024, under the Klink partnership program, in collaboration with the Association of Rural Surgeons of India. Since 2022, affiliated institutions have been compiling monthly reports, which will be used to evaluate the primary focus areas for rural hospitals in India. The effectiveness of the GILLS training program will be assessed by proctoring the documented number of surgical procedures. By analysing hospital records from the year before and after the last surgical camp, the annual number of operations performed post-GILLS implementation will be determined. Alternatively, if data for a few months is available, it will be extrapolated to a year. The extrapolation was carried out by calculating average statistics for a month from the data available and multiplying by 12.

Inclusion Criteria:

• Hospitals empowered with GILLS and proctorship programs for gas-less laparoscopic surgeries are part of the study group.
• Hospitals interested but unable to start GILLS during the study period serve as controls.

Exclusion Criteria:

• Hospitals without online proctorship and not empowered with GILLS.

Target Areas: The target population is based on the local hospital’s usual outpatient and surgical patients. Associated hospitals and their immediate and extended target populations for surgical care are listed.

Limitations: The study’s limitations include potential unaccounted confounding variables and limited generalizability due to the small sample size, which may not represent the entire rural hospital population in India. The extrapolated data may not represent the complete year data because the seasonal variations in the number of surgical procedures carried out as many patients do not want surgical procedures in summer.

The control groups could have been taken from hospitals near the area of the study group serving similar populations and could have been from a larger number of hospitals. However, it would have been difficult to get accurate information from the hospitals who have no reason to share their data with us. On the other hand, the smaller control group hospitals gave access to their data.

The surgical coverage rate was calculated using the formula:

Surgical Coverage Rate = [ (No. of Surgeries per year / Target Population)] x 100000

Table 1 summarizes the surgical coverage rates for the immediate and extended populations before and after empowering hospitals with GILLS. Table 2 highlights statistics for case hospitals showing the mean, standard deviation, minimum, maximum, and median number of surgeries per year before and after implementing the GILLS technique. 

Mean value for case hospitals before empowering and after empowering with GILLS

In regard to that, the percentage rise in the mean number of surgeries that occurred after empowerment was certainly 245% higher than it was before. Along the same lines, the percentage increase in the mean surgical coverage rate for the immediate population is 270%. In a similar vein, the average percentage increase in surgical coverage rate for broad populations is 662 percent

Test of Normality: The Shapiro-Wilk test indicated that the dataset does not follow a normal distribution (p < 0.05).

Wilcoxon Signed-Rank Test Results:

Surgeries per year / Surgical coverage for immediate population / Surgical coverage rate per 100,000 for extended population

• Negative Ranks: 0
• Positive Ranks: 17
• Ties: 0
• Z statistic: -3.622
• p value: 0.000
• Effect size (r): 0.88

All comparisons between pre- and post-intervention data showed statistically significant improvements (p < 0.001) with a large effect size (r = 0.88).

These results indicate a statistically significant increase in surgical coverage rate after the implementation of the GILLS technique, supporting the alternative hypothesis.

Linear Regression Results:

Surgeries/year prior to empowering:

• R2=0.32R^2 = 0.32R2=0.32
• Significant F-test: F = 6.91, p = 0.018

Surgical coverage rate for immediate population:

• R2=0.42R^2 = 0.42R2=0.42
• Significant F-test: F = 10.92, p = 0.004

Linear Regression Analysis:

• The variable “Surgeries/year after empowering” had the greatest influence on “Surgeries/year prior to empowering” with a standardized beta coefficient indicating strong predictive power.
• The p-value for “Surgeries/year after empowering” was 0.019, confirming the coefficient is significantly different from zero.
• The p-value for “Surgical coverage rate for immediate population after empowering” was 0.005, indicating a significant positive impact.
• However, the p-value for “Surgical coverage rate for extended population /100,000 after empowering” was 0.856, suggesting no significant difference.

Summary of Results for Control Hospitals

Table 3 shows statistics for control hospitals showing the mean, standard deviation, minimum, maximum, and median number of surgeries two years prior to 2022 and two years after 2022.

Mean value for control hospitals two years before and after 2022

A twenty percent rise in the average number of surgical procedures is seen, with twenty-one percent being the immediate goal and twenty percent being the extended target group.

Key findings include:

1. Surgical Volume: The median number of surgeries per year slightly increased from 720 before February 2022 to 830 after February 2022. However, this increase was not statistically significant.
2. Immediate Population Coverage: The median surgical coverage rate for the immediate population increased from 1200 to 1383, but this change was also not statistically significant.
3. Extended Population Coverage: The median surgical coverage rate per 100,000 for the extended population increased from 639.8 to 770.8, but again, the change was not statistically significant.
4. Statistical Analysis:

• Descriptive Statistics: The mean surgeries per year increased from 740 (SD = 675.4) to 891.8 (SD = 838.08). The mean surgical coverage rates for immediate and extended populations also showed slight increases.
• t-Tests for Independent Samples: The t-tests revealed no statistically significant differences between the pre- and post-periods in terms of surgeries per year and surgical coverage rates for both populations.

The null hypothesis, stating there is no difference between the surgeries performed before and after the specified period, was retained. Thus, for the control hospitals, there is no significant difference in surgical volumes or coverage rates before and after February 2022.

The study found that hospitals using Gas Insufflation-Less Laparoscopic Surgery (GILLS) saw significant increases in coverage rates from February 2022 to February 2024. In this sense, the average number of procedures increased by 245% after empowerment. Similarly, the immediate population’s mean surgical coverage rate increased by 270%. In a similar vein, the average percentage increase in surgical coverage rate for extended target populations is 662%. Hospitals that implemented GILLS saw a statistically significant increase in the number of procedures conducted (r = 0.88). Linear regression analysis also confirmed the positive impact of GILLS on surgical volumes.

While control hospitals showed no significant changes in surgical volumes or coverage rates during the same period. It is seen that increase the average number of surgical procedures by 20%, with 21% as the immediate target and 20% as the extended target group. Five control hospitals interested in the GILLS technique but not yet implementing it were studied from February 2022 to February 2024. Surgical coverage rates were calculated for both the immediate and extended populations before and after this period as shown in Table 4. Overall, the results support the effectiveness of GILLS in enhancing surgical access in rural and underprivileged areas of India.

While the study provides strong evidence for the effectiveness of GILLS in increasing surgical volumes in rural Indian hospitals, the findings may not be directly generalizable to other LMICs with different healthcare systems and infrastructures. Future research should explore the applicability of GILLS in diverse settings.

This result underscores the relevance and potential impact of this study on a global scale. Global surgery initiatives aim to improve access to safe, affordable surgical and anesthesia care worldwide.  The GILLS contributes to these global efforts by demonstrating an innovative surgical approach that can be adapted for use in resource-constrained settings, thereby expanding access to essential surgical services. So far public health challenges in low middle income countries are concerned, In LMICs, public health systems often face significant challenges, including limited healthcare infrastructure, shortages of trained healthcare professionals, and inadequate medical equipment. These challenges are compounded by the high burden of surgical conditions that require timely intervention. Minimally invasive surgeries like GILLS, which reduce reliance on advanced infrastructure and specialized equipment, are particularly relevant in these contexts. By showcasing how GILLS can be effectively implemented in rural and underserved areas, the study provides a model for improving surgical care where traditional laparoscopic methods may not be feasible.

The data collected through this study not only informs clinical practices but also provides valuable insights for policymakers and health system planners. The evidence generated can guide the allocation of resources, the development of training programs for healthcare professionals, and the implementation of surgical techniques that are both cost-effective and scalable in LMICs. This evidence-based approach is critical for making informed decisions that enhance the sustainability and effectiveness of healthcare interventions.

This study lays the groundwork for future research into minimally invasive techniques and their adaptation in various healthcare settings. It encourages further exploration into how these innovations can be refined and scaled to meet the diverse needs of LMICs.

Limitations

The study has certain limitations, such as unaccounted confounding variables. Various factors beyond surgical empowerment could influence the outcomes observed, such as changes in healthcare policies, local socioeconomic conditions, availability of skilled healthcare personnel, and patient health-seeking behaviors. These confounding variables may not have been adequately controlled or accounted for in the study. Due to the small sample size, it is possible that the findings of the study cannot be generalized to all rural hospitals in India or to other healthcare settings. This is because the sample size may not correctly represent the population of rural hospitals as a whole. The characteristics, patient demographics, infrastructure, and resources of each hospital might vary greatly, which can have an impact on the outcomes of surgical procedures and the percent of patients who are covered. It is difficult to draw general conclusions from this study that are applicable to a variety of healthcare settings because the sample size is quite small. In spite of the fact that the study offers insightful information regarding the effects of surgical empowerment in certain rural hospitals, the findings of the study must to be evaluated with caution because to the limitations that were discussed before.

The GILLS technique represents a significant advancement in making laparoscopic surgery more accessible and feasible for rural and underprivileged areas. This study provides strong evidence of its positive impact on surgical volumes and coverage rates in Indian rural hospitals. Future efforts should focus on scaling up training programs, addressing potential barriers, and ensuring the long-term sustainability of these advancements to continue improving surgical care access and outcomes in underserved populations.

Recommendations

Based on our findings, we recommend the following:

1. Encourage the wider adoption of gas-less laparoscopic surgery in rural healthcare settings, both within India and globally, to improve surgical access and capacity in resource-limited regions. Given the significant impact of interventions like GILLS, there is a need to expand and scale-up similar empowering initiatives across rural healthcare settings. Policymakers should include gas-less laparoscopic surgery in the UHC benefit package to ensure that it is accessible to all patients, especially in rural and underserved areas. Develop and implement standardized protocols and guidelines for gas-less laparoscopic surgery to maintain high-quality care[5]
2. Provide training and educational programs for healthcare professionals on the implementation and utilization of gas-less laparoscopic techniques to ensure safe and effective surgical practice.
3. Advocate for policy initiatives and funding support to facilitate the integration of gas-less laparoscopic surgery into rural healthcare systems, recognizing its potential to address surgical disparities and improve population health outcomes.[4]
4. Foster collaborative partnerships between healthcare institutions, government agencies, non-profit organizations, and industry stakeholders to facilitate the dissemination and implementation of gas-less laparoscopic surgery in underserved communities.
5. Implement robust data collection and monitoring systems to evaluate the outcomes and impact of gas-less laparoscopic surgery under UHC. Use the data to inform continuous quality improvement initiatives and ensure that the surgical care provided meets the highest standards.[5]
6. Conduct awareness campaigns to educate communities about the availability and benefits of gas-less laparoscopic surgery under UHC. Provide continuous education opportunities for healthcare professionals to stay updated with the latest advancements in laparoscopic techniques.
7. Establish comprehensive training programs for surgeons and healthcare workers on gas-less laparoscopic techniques to ensure proficiency and safety. Invest in the necessary infrastructure and equipment to support the widespread adoption of gas-less laparoscopic surgery in rural hospitals.[6]
8. Conduct longitudinal studies to assess the long-term impact of empowerment programs. This can provide more comprehensive insights into how such interventions influence surgical coverage over time.
9. Improve data collection methods for the extended population to ensure accuracy and completeness. This might involve using technology for remote data collection and engaging local communities in the data gathering process.
10. Implement complementary strategies to address socioeconomic barriers, such as subsidies for transportation, health education campaigns, and collaborations with local organizations.[12]

By understanding and addressing these specific challenges, future interventions can be more effectively designed to improve surgical coverage rates for extended populations in rural and underserved areas. By embracing these recommendations and continuing to innovate in surgical care delivery, we can work towards achieving equitable access to high-quality healthcare for all, irrespective of geographical location or socioeconomic status. Gas-less laparoscopic surgery represents a promising avenue for realizing this vision and transforming surgical care in rural settings in India.

In conclusion, the GILLS plays a crucial role in advancing global surgery initiatives and can address public health challenges in LMICs. Its findings not only improve surgical care access and quality but also contribute to broader global health efforts aimed at achieving equitable healthcare for all. Through evidence-based practices, international collaboration, and a focus on sustainability, this study exemplifies how innovative healthcare solutions can have a profound impact on global health.

Above all, I would want to express my sincere gratitude to Prof. Dr. Georgi Chaltikyan, my supervisor, whose advice, support, and knowledge were vital during this process. Your resolute assistance and perceptive criticism have greatly enhanced my writing and study.
I owe a great deal to my co-supervisor, Prof. Dr. Gnanaraj Jesudian, and Prof. Dr. Henning Mothes for his invaluable assistance with my thesis at every stage, from developing the methodology to coming up with the title, as well as for his careful evaluation and on-going direction. Your commitment and wise counsel have greatly influenced my effort.
A special acknowledgment goes to my spiritual Guide, Guru Maharaj Krishna Kant Sharma Ji. Your teachings and blessings have been a source of immense inspiration and strength throughout my academic journey. Your wisdom has profoundly impacted my approach to both my studies and my life, and for that, I am eternally grateful
Tanisha and Karan Bisht, my younger sister and brother, have my everlasting thanks for the moral support they have provided and for the fact that they have made this trip both memorable and enjoyable. The importance of your assistance and participation in my academic path cannot be overstated.
I would want to convey my appreciation to Dr. Deepali Upadhyay and my family, in particular to my mother Renu Devi, my father Nawal Kishor Mallik, my elder brother Rahul Mallick, Anjali Mallik and Mukul Mallik, for their unflinching love, their perseverance, and their selflessness. The trust that you have placed in me has always been a source of inspiration and strength for me.
Finally, I want to thank Dr. Nikita Mokal and Nitish Kumar Gaurav for their unwavering support during the writing of my thesis.