Barriers to training in laparoscopic surgery in low- and middle-income countries: A systematic review

Laparoscopic surgery has the potential to improve care in resource-deprived low- and-middle-income countries (LMICs). This study aims to analyse the barriers to training in laparoscopic surgery in LMICs. Medline, Embase, Global Health and Web of Science were searched using ‘LMIC’, ‘Laparoscopy’ and ‘Training’. Two researchers screened results with mutual agreement. Included papers were in English, focused on abdominal laparoscopy and training in LMICs. PRISMA guidelines were followed; 2992 records were screened, and 86 full-text articles reviewed to give 26 key papers. Thematic grouping identified seven key barriers: funding; availability and maintenance of equipment; local access to experienced laparoscopic trainers; stakeholder dynamics; lack of knowledge on effective training curricula; surgical departmental structure and practical opportunities for trainees. In low-resource settings, technological advances may offer low-cost solutions in the successful implementation of laparoscopic training and improve access to surgical care.

Assessment of Laparoscopic Instrument Reprocessing in Rural India: A Mixed Methods Study

Background
Laparoscopy is a minimally-invasive surgical procedure that uses long slender instruments that require much smaller incisions than conventional surgery. This leads to faster recovery times, fewer infections and shorter hospital stays. For these reasons, laparoscopy could be particularly advantageous to patients in low to middle income countries (LMICs). Unfortunately, sterile processing departments in LMIC hospitals are faced with limited access to equipment and trained staff and poses an obstacle to safe surgical care. The reprocessing of laparoscopic devices requires specialised equipment and training. Therefore, when LMIC hospitals invest in laparoscopy, an update of the standard operating procedure in sterile processing is required. Currently, it is unclear whether LMIC hospitals, that already perform laparoscopy, have managed to introduce updated reprocessing methods that minimally invasive equipment requires. The aim of this study was to identify the laparoscopic sterile reprocessing procedures in rural India and to test the effectiveness of the sterilisation equipment.
Methods
We assessed laparoscopic instrument sterilisation capacity in four rural hospitals in different states in India using a mixed-methods approach. As the main form of data collection, we developed a standardised observational checklist based on reprocessing guidelines from several sources. Steam autoclave performance was measured by monitoring the autoclave cycles in two hospitals. Finally, the findings from the checklist data were supported by an interview survey with surgeons and nurses.
Results
The checklist data revealed the reprocessing methods the hospitals used in the reprocessing of laparoscopic instruments. It showed that the standard operating procedures had not been updated since the introduction of laparoscopy and the same reprocessing methods for regular surgical instruments were still applied. The interviews conrmed that staff had not received additional training and that they were unaware of the hazardous effects of reprocessing detergents and disinfectants.
Conclusion
As laparoscopy is becoming more prevalent in LMICs, updated policy is needed to incorporate minimally invasive instrument reprocessing in medical practitioner and staff training programs. While reprocessing standards improve, it is essential to develop instruments and reprocessing equipment that is
more suitable for resource-constrained rural surgical environments.

Steerable and Reusable Bipolar Vessel Sealer: Design, Development and Validation

A new radical design approach arose from the need to develop a bipolar electrosurgical instrument that is modular and cleanable, thus reusable and therefore suitable for low- and middle-income countries (LMICs). Advanced Bipolar Vessel Sealer (BVS) instruments that are currently on the market cannot be cleaned or maintained well and are therefore most often sold as disposables. Especially in LMICs it is a significant financial burden for hospitals. This possibly leads to the re-use of single-use intended instruments which in turn jeopardizes patient safety. Simultaneously, designing a reusable instrument fits well in the transition to a more circular and sustainable society. To perform advanced laparoscopic surgery with cleanable and affordable electrosurgical instruments, a new design approach is needed. A first phase was initiated by the creation of a cable less steering principle called Shaft Actuated Tip Articulation (SATA) mechanism [6]. Unfortunately, by adding electrically conductive wires to a SATA instrument it loses its modularity and thus cleanability, precisely for which the SATA technology offered a solution in the first place. In addition, there are no non-robotically controlled and reusable BVS instruments with two DOFs available on the market. By being steerable, the user of the instrument is able to deliver a higher quality seal as well as to seal more difficult-to-reach blood vessels and tissue. In this thesis project the goal is to redesign a SATA instrument which sustains bipolar vessel sealing and thus designing a BVS that is easy to clean, easily disinfected and sterilized and which is reusable for a vast amount of surgical procedures. Ideas have been gained by analysing the SATA mechanism and studying commonly used BVS devices. A systematic selection procedure based on the design requirements has resulted in a winning concept for the conduction of electricity through the SATA instrument. For the design of the tip, determining factors were elaborated on, including the construction of the open and close mechanism and the force transmission ratio between the required seal force on the blood vessel or tissue and the necessary tensile force in the core of the instrument. The most critical components of the final model have been identified and evaluated by means of FEM simulations and an experiment. The FEM simulations of the tip components show that the design is satisfactory and that a safety factor of ~1.5 has been achieved. This means that these components do not fail due to normal use and they have a long lifespan as well. In the experiment a flexible nitinol guidewire with Teflon coating was tested for wear by pulling the guidewire through an angled SATA hinge. After some necessary adjustments and additions to the design of the BVS, the results were improved but not optimal. The outcome of this project is a good basis for the BVS design where the steerability has been maintained as well as the modularity and cleanability. The reusability depending on the flexible coating around the core needs to be further investigated and improved.

Barriers and facilitators of laparoscopic surgical training in rural north-east India: a qualitative study

Introduction:
Laparoscopic surgery has advantages for treating many abdominal surgical conditions, but its use in low and middle-income countries (LMICs) is limited by many factors, including a lack of training opportunities. The aim of this study was to explore the training experiences of surgeons in rural north-east India to highlight the barriers and facilitators to laparoscopic surgery.

Methods:
Eleven surgeons with experience in laparoscopy in rural north-east India were recruited using purposive and convenience sampling. Ethical approval was obtained from the Institutional Ethics Committee, Maulana Azad Medical College, New Delhi, India and the Leeds Institute of Health Sciences Research Ethics Sub-Committee, West Yorkshire, England. Consenting participants took part in semi-structured interviews, either between May 20 and 25, 2019 in rural north-east India or via Skype or at the University of Leeds in June 2019. Interviews were audio-recorded and transcribed and thematic content analysis performed.

Results:
Exposure to laparoscopy during postgraduate training was common, but training experiences were inconsistent and informal. Alternative training opportunities are limited by availability and cost. There is high demand for a structured curriculum, incorporating formal assessment and credentialing, to include observation and assistance in live surgery and laparoscopic simulation.

Conclusions:
Laparoscopic training experiences are highly variable, with limited training resources and lack of a curriculum. Poor accessibility is consistent with that recorded in literature. Current recommendations include government support and funding to guide development of a standardized curriculum and widen access to training programs for surgeons in rural settings.

Laparoscopic vs open colorectal surgery: Economic and clinical outcomes in the Brazilian healthcare

Laparoscopic surgery has become the preferred surgical approach of several colorectal conditions. However, the economic results of this are quite controversial. The degree of adoption of laparoscopic technology, as well as the aptitude of the surgeons, can have an influence not only in the clinical outcomes but also in the total procedure cost. The aim of this study was to evaluate the clinical and economic outcomes of laparoscopic colorectal surgeries, compared to open procedures in Brazil.All patients who underwent elective colorectal surgeries between January 2012 and December 2013 were eligible to the retrospective cohort. The considered follow-up period was within 30 days from the index procedure. The outcomes evaluated were the length of stay, blood transfusion, intensive care unit admission, in-hospital mortality, use of antibiotics, the development of anastomotic leakage, readmission, and the total hospital costs including re-admissions.Two hundred eighty patients, who met the eligibility criteria, were included in the analysis. Patients in the laparoscopic group had a shorter length of stay in comparison with the open group (6.02 ± 3.86 vs 9.86 ± 16.27, P < .001). There were no significant differences in other clinical outcomes between the 2 groups. The total costs were similar between the 2 groups, in the multivariate analysis (generalized linear model ratio of means 1.20, P = .074). The cost predictors were the cancer diagnosis and age.Laparoscopic colorectal surgery presents a 17% decrease in the duration of the hospital stay without increasing the total hospitalization costs. The factors associated with increased hospital costs were age and the diagnosis of cancer.

Safe Laparoscopy in Low and Middle Income Countries by reducing Surgical Site Infections through Laparoscopic Instrument Cleaning

Access to safe and affordable surgery is nothing short of a basic human right and people from all walks of life are entitled to it. But, five people from resource-constrained low and middle-income countries are vulnerable and left to fend for themselves when the need for surgery is a life governing event. Inhabitants of these regions are scourged by high mortality and morbidity due to surgical infection caused by the use of unclean and unsterile surgical instruments. Reduction in infections can be achieved by using clean and sterile surgical instruments. Laparoscopy, is a promising technique of surgery developed to efficiently perform complex abdominal surgeries with the use of small and minimum incisions on the patient. Laparoscopy’s minimally invasive nature allows complex surgeries to take place without the need of an absolutely sterile operating room, although the sterility of the surgical instruments cannot be compromised. The added benefit of faster recovery from smaller wounds makes it even more desirable for this context. The Minimally Invasive Surgery and Interventional Techniques Lab of the TU Delft has initiated projects addressing the health and well-being of resource-constrained, underdeveloped communities like rural India through frugal innovation. Rural Indian hospitals are grossly underfunded, under-maintained, and understaffed. Sterile processing practices in rural India are rudimentary compared to high-income hospitals like the ones in the Netherlands. In high-income hospitals, all used surgical instruments are cleaned and sterilized in dedicated central sterile processing departments (CSSD) by highly trained and well protected sterile processing technicians. However, rural India usually employs small teams of local undertrained and semi-literate nurses to carry out every primary and ancillary duty in the hospital. The lack of dedicated CSSDs exacerbates the nurse’s workload and exposure to harmful pathogenic surgical instruments. Laparoscopic instruments developed in high-income nations are seldom designed keeping low resource contexts in mind. The geometrical complexity of instruments keeps increasing but cleaning methods in rural India have stagnated. Resource constraints are a major reason as to why proper international and national guidelines for reprocessing cannot be followed. Hence hospitals cannot guarantee 100% safe and sterile instruments as compared so standardized outcomes in high-income hospitals. In this graduation project, the distinct reprocessing journey of surgical instruments for the two diverse economic contexts were studied. A comparative analysis of both reprocessing journeys uncovered severe unsafe and unfavorable practices in rural India. Significant data and insights from the research have hence paved the way for focusing on the “Cleaning” stage of the laparoscopic instrument reprocessing journey in rural India. This MSc graduation project aims at designing a frugal solution for cleaning and repurposing laparoscopic instruments, dedicated to hospitals in rural India where the demand for laparoscopy is high but surgeries are less due to resource constraints like lack of laparoscopic instruments and repurposing devices. The involvement of an Indian nurse and laparoscopic surgeon provided first-hand information about the problems and requirements in the rural Indian context. Prototyping and testing of various cleaning setups were conducted to extract the most viable design solution. Insights from the research and testing were combined into the concept design of a frugal mechanical washer and subsequently an “Envisioned Reprocessing Journey” for rural Indian hospitals to suggest a standard protocol for keeping most of their existing infrastructure in mind. Evaluations with the Indian nurse revealed that this device could indeed be a game-changer to the existing practices of reprocessing laparoscopic instruments in rural India.

Gasless Laparoscopic Surgery for Minimally Invasive Surgery in Low-Resource Settings: Methods for Evaluating Surgical Field of View and Abdominal Wall Lift Force

Laparoscopic surgery has advantages over open surgery for several abdominal conditions due to improved short-term outcomes. Performing laparoscopic surgery in many low and middle-income country (LMIC) settings is restricted by the lack of general anaesthesia (GA) and carbon dioxide (CO2) insufflation. Gasless laparoscopic surgery employs the use of a mechanical anterior abdominal wall lift device to create internal space within the abdomen. This negates the need for GA and CO2 which may help increase adoption of laparoscopic surgery in LMIC settings.

The safety and efficacy of gasless techniques appear to be non-inferior when compared to conventional laparoscopic surgery for many gastrointestinal and gynaecological conditions.3 However, concerns from surgeons before adopting this technique are operative field of view and safety concerns including damage to the abdominal wall during the lift.3 Many lift devices produce a tenting effect, creating an angular cavity that can restrict view. Monitoring to ensure a ‘safe’ force is applied is also essential, as lifting the abdominal wall carries the potential for trauma if too much force is applied. Our aim was to develop methods that may be used in future clinical studies aimed at mitigating these concerns by assessing field of view and force exerted on tissues during gasless lift procedures.

Establishing a Sustainable Training Program for Laparoscopy in Resource-Limited Settings: Experience in Ghana

Background:
Healthcare equipment funded by international partners is often not properly utilized in many developing countries due to low levels of awareness and a lack of expertise. A long-term on-site training program for laparoscopic surgery was established at a regional hospital in Ghana upon request of the Ghana Health Service and local surgeons.

Objective:
The authors report the initial 32-month experience of implementing laparoscopic surgery focusing on the trainees’ response, technical independence, and factors associated with the successful implementation of a “new” surgical practice.

Methods:
Curricular structure and feedback results of the trainings for doctors and nurses, and characteristics of laparoscopic procedures performed at the Greater Accra Regional Hospital between January 2017 and September 2019 were retrospectively reviewed.

Findings:
Comprehensive training including two weeks of simulation workshops followed by animal labs were regularly provided for the doctors. Among the 97 trainees, 27.9% had prior exposure in laparoscopic surgery, 95% were satisfied with the program. Eleven nurses attained professional competency over 15 training sessions where none had prior exposure to laparoscopic surgery. Since the first laparoscopic cholecystectomy in February 2017, 82 laparoscopic procedures were performed. The scope of the surgery was expanded from general surgery (n = 46) to gynecology (n = 33), pediatric surgery (n = 2), and urology (n = 1). The volume of local doctors as primary operators increased from 0% (0/17, February to December 2017) to 41.9% (13/31, January to October 2018) and 79.4% (27/34, November 2018 to September 2019), with 72.5% of the cases being assisted by the expatriate surgeon. There were no open conversions, technical complications, or mortalities. Local doctors independently commenced endoscopic surgical procedures including cystoscopies, hysteroscopies, endoscopic neurosurgeries and arthroscopies.

Conclusion:
Sensitization and motivation of the surgical workforce through long-term continuous on-site training resulted in the successful implementation of laparoscopic surgery with a high level of technical independence.

Optical Trocar Causing Aortic Injury: A Potentially Fatal Complication of Minimal Access Surgery

Trocar injury to abdominal aorta is uncommon and even rare with optical trocars. Such injury, resulting from umbilical trocar insertion, is potentially fatal. It often causes on-table death due to torrential life-threatening haemorrhage and unavailability of expert vascular help. We present a rare case of an injury to infra-renal abdominal aorta, caused by optical trocar insertion for bariatric surgery. Immediate recognition of the injury, deployment of life-saving manoeuvres, timely resuscitation, followed by definitive repair of aorta by vascular surgeon was life-saving for this patient. The recovery phase was uneventful and patient had no residual clinical problems during follow-up.

Propensity score matching comparison of laparoscopic versus open surgery for rectal cancer in a middle-income country: short-term outcomes and cost analysis.

Laparoscopic surgery for rectal cancer is associated with improved postoperative outcomes compared to open surgery; however, economic studies have yielded contradictory results. The aim of this study was to compare the clinical and economic outcomes of laparoscopic versus open surgery for patients with rectal cancer.Propensity score matching analysis was performed in a retrospective cohort of patients who underwent elective low anterior resection for rectal cancer treatment by laparoscopic and open surgery in a single Brazilian cancer center. Matched covariates included age, gender, body mass index, pTNM stage, American Society of Anesthesiologists score, type of anesthesia, neoadjuvant chemoradiotherapy, and interval between neoadjuvant chemoradiotherapy and index surgery. The clinical and economic outcomes were evaluated. The follow-up period was within 30 days of the index procedure. The clinical outcomes were reoperation, postoperative complications, operative time, length of stay in the intensive care unit, and postoperative hospital stay. For economic outcomes, a cost analysis was used to compare the costs.Initially, 220 patients were evaluated. After propensity score matching, 100 patients were included in the analysis (50 patients in the open surgery group and 50 patients in the laparoscopic surgery group). There were no differences in patients’ baseline characteristics. Operative time was longer for laparoscopic surgery (247 minutes vs 285 minutes, P=0.006). There were no significant differences in other clinical outcomes. The hospital costs were similar between the two groups (Brazilian reais 21,233.15 vs Brazilian reais 21,529.28, P=0.115), although the intraoperative costs were higher for laparoscopic surgery, mainly owing to the surgical devices and the theater-related costs. The postoperative costs were lower for laparoscopic surgery, owing to lower intensive care unit, ward, and reoperation costs.Laparoscopic surgery for rectal cancer is not costlier than open surgery from the health care provider’s perspective, since the intraoperative costs were offset by lower postoperative costs. Open surgery tends to have a longer length of stay.