Gasless laparoscopy in rural India-registry outcomes and evaluation of the learning curve.

BACKGROUND: A program of gasless laparoscopy (GL) has been implemented in rural North-East India. To facilitate safe adoption, participating rural surgeons underwent rigorous training prior to independent clinical practice. An online registry was established to capture clinical data on safety and efficacy and to evaluate initial learning curves for gasless laparoscopy. METHODS: Surgeons who had completed the GL training program participated in the online RedCap Registry. Patients included in the registry provided informed consent for the use of their data. Data on operative times, conversion rates, perioperative complications, length of stay, and hospital costs were collected. Fixed reference cumulative sum (CUSUM) model was used to evaluate the learning curve based on operative times and conversion rates published in the literature. RESULTS: Four surgeons from three rural hospitals in North-East India participated in the registry. The data were collected over 12 months, from September 2019 to August 2020. One hundred and twenty-three participants underwent GL procedures, including 109 females (88.6%) and 14 males. GL procedures included cholecystectomy, appendicectomy, tubal ligation, ovarian cystectomy, diagnostic laparoscopy, and adhesiolysis. The mean operative time was 75.3 (42.05) minutes for all the surgeries. Conversion from GL to open surgery occurred in 11.4% of participants, with 8.9% converted to conventional laparoscopy. The main reasons for conversion were the inability to secure an operative view, lack of operating space, and adhesions. The mean length of stay was 3 (2.1) days. The complication rate was 5.7%, with one postoperative death. The CUSUM analysis for GL cholecystectomy showed a longer learning curve for operative time and few conversions. The learning curve for GL tubal ligation was relatively shorter. CONCLUSION: Gasless laparoscopy can be safely implemented in the rural settings of Northeast India with appropriate training programs. Careful case selection is essential during the early stages of the surgical learning curve.

The RAIS Device for Global Surgery: Using a Participatory Design Approach to Navigate the Translational Pathway to Clinical Use.

BACKGROUND: Over 5 billion people worldwide have no access to surgery worldwide, typically in low-resource settings, despite it being a primary life-saving treatment. Gas Insufflation-Less Laparoscopic Surgery (GILLS) can address this inequity, by improving current GILLS instrumentation to modern surgical standards. OBJECTIVE: to develop and translate a new Retractor for Abdominal Insufflation-less Surgery (RAIS) into clinical use and thus provide a context-appropriate system to advance GILLS surgery. METHODS: A collaborative multidisciplinary team from the UK and India was formed, embedding local clinical stakeholders and an industry partner in defining user and contextual needs. System development was based on a phased roadmap for 'surgical device design in low resource settings' and embedded participatory and frugal design principles in an iterative process supported by traditional medical device design methodologies. Each phase of development was evaluated by the stakeholder team through interactive workshops using cadaveric surgical simulations. A Commercialisation phase undertook Design to Manufacture and regulatory approval activities. Clinical validation was then conducted with rural surgeons performing GILLS procedures using the RAIS system. Semi-structured questionnaires and interviews were used to evaluate device performance. RESULTS: A set of user needs and contextual requirements were defined and formalised. System development occurred across five iterations. Stakeholder participation was instrumental in converging on a design which met user requirements. A commercial RAIS system was then produced by an industry partner under Indian regulatory approval. This was successfully used in clinical validation to conduct 12 surgical procedures at two locations in rural India. Surgical feedback showed that the RAIS system provided a valuable and usable surgical instrument which was appropriate for use in low-resource contexts. CONCLUSIONS: Using a context-specific development approach with close engagement of stakeholders was crucial to develop the RAIS system for low-resource regions. The outcome is translation from global health need into a fully realized commercial instrument which can be used by surgeons in low-resource regions across India.

Training programme in gasless laparoscopy for rural surgeons of India (TARGET study) - Observational feasibility study.

BACKGROUND: Benefits of laparoscopic surgery are well recognised but uptake in rural settings of low- and middle-income countries is limited due to implementation barriers. Gasless laparoscopy has been proposed as an alternative but requires a trained rural surgical workforce to upscale. This study evaluates a feasibility of implementing a structured laparoscopic training programme for rural surgeons of North-East India. METHODS: A 3-day training programme was held at Kolkata Medical College in March 2019. Laparoscopic knowledge and Fundamentals of Laparoscopic Skills (FLS) were assessed pre and post simulation training using multiple choice questions and the McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS), respectively. Competency with an abdominal lift device was assessed using the Objective Structured Assessment of Technical Skills (OSATS) and live operating performance via the Global Operative Assessment of Laparoscopic Skills (GOALS) scores during live surgery. Costs of the training programme and qualitative feedback were evaluated. RESULTS: Seven rural surgeons participated. There was an improvement in knowledge acquisition (mean difference in MCQ score 5.57 (SD = 4.47)). The overall normalised mean MISTELS score for the FLS tasks improved from 386.02 (SD 110.52) pre-to 524.40 (SD 94.98) post-training (p = 0.09). Mean OSATS score was 22.4 out of 35 (SD 3.31) indicating competency with the abdominal lift device whilst a mean GOALS score of 16.42 out of 25 (SD 2.07) indicates proficiency in performing diagnostic laparoscopy using the gasless technique during live operating. Costs of the course were estimated at 354 USD for trainees and 461 USD for trainers. CONCLUSION: Structured training programme in gasless laparoscopy improves overall knowledge and skills acquisition in laparoscopic surgery for rural surgeons of North-East India. It is feasible to deliver a training programme in gasless laparoscopy for rural surgeons. Larger studies are needed to assess the benefits for wider adoption in a similar context.

Clinical effectiveness of gasless laparoscopic surgery for abdominal conditions: systematic review and meta-analysis.

BACKGROUND: In high-income countries, laparoscopic surgery is the preferred approach for many abdominal conditions. Conventional laparoscopy is a complex intervention that is challenging to adopt and implement in low resource settings. This systematic review and meta-analysis evaluate the clinical effectiveness of gasless laparoscopy compared to conventional laparoscopy with CO2 pneumoperitoneum and open surgery for general surgery and gynaecological procedures. METHODS: A search of the MEDLINE, EMBASE, Global Health, AJOL databases and Cochrane Library was performed from inception to January 2021. All randomised (RCTs) and comparative cohort (non-RCTs) studies comparing gasless laparoscopy with open surgery or conventional laparoscopy were included. The primary outcomes were mortality, conversion rates and intraoperative complications. SECONDARY OUTCOMES: operative times and length of stay. The inverse variance random-effects model was used to synthesise data. RESULTS: 63 studies were included: 41 RCTs and 22 non-RCTs (3,620 patients). No procedure-related deaths were reported in the studies. For gasless vs conventional laparoscopy there was no difference in intraoperative complications for general RR 1.04 [CI 0.45-2.40] or gynaecological surgery RR 0.66 [0.14-3.13]. In the gasless laparoscopy group, the conversion rates for gynaecological surgery were high RR 11.72 [CI 2.26-60.87] when compared to conventional laparoscopy. For gasless vs open surgery, the operative times were longer for gasless surgery in general surgery RCT group MD (mean difference) 10 [CI 0.64, 19.36], but significantly shorter in the gynaecology RCT group MD - 18.74 [CI - 29.23, - 8.26]. For gasless laparoscopy vs open surgery non-RCT, the length of stay was shorter for gasless laparoscopy in general surgery MD - 3.94 [CI - 5.93, - 1.95] and gynaecology MD - 1.75 [CI - 2.64, - 0.86]. Overall GRADE assessment for RCTs and Non-RCTs was very low. CONCLUSION: Gasless laparoscopy has advantages for selective general and gynaecological procedures and may have a vital role to play in low resource settings.

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.

Transfusion-associated anxiety: Recognised and overcome in an adolescent child.

A 12-year-old boy presented to our palliative care cancer clinic with Ewing Sarcoma and anaemia in failure. Transfusion reactions were noted during several blood transfusions, which manifested as acute onset of breathlessness, mild chest pain, sweating, general discomfort, increased heart rate, respiratory rate, and blood pressure. All the possible causes of transfusion reaction were ruled out, other than transfusion-associated anxiety resembling transfusion reaction. In this case, adequate reassurance, counselling about the blood transfusion, distraction techniques, and the visual technique of masking the blood bag with black polythene foil helped overcome the patient's anxiety during the blood transfusion, and was uneventful henceforth. Since transfusion-associated anxiety is not an established and well-studied aspect of transfusion medicine yet, there is a need to have high clinical suspicion to recognise, assess, and forthwith prevent any such transfusion reactions without any delay.

Disseminating technology in global surgery.

BACKGROUND: Effective dissemination of technology in global surgery is vital to realize universal health coverage by 2030. Challenges include a lack of human resource, infrastructure and finance. Understanding these challenges, and exploring opportunities and solutions to overcome them, are essential to improve global surgical care. METHODS: This review focuses on technologies and medical devices aimed at improving surgical care and training in low- and middle-income countries. The key considerations in the development of new technologies are described, along with strategies for evaluation and wider dissemination. Notable examples of where the dissemination of a new surgical technology has achieved impact are included. RESULTS: Employing the principles of frugal and responsible innovation, and aligning evaluation and development to high scientific standards help overcome some of the challenges in disseminating technology in global surgery. Exemplars of effective dissemination include low-cost laparoscopes, gasless laparoscopic techniques and innovative training programmes for laparoscopic surgery; low-cost and versatile external fixation devices for fractures; the LifeBox pulse oximeter project; and the use of immersive technologies in simulation, training and surgical care delivery. CONCLUSION: Core strategies to facilitate technology dissemination in global surgery include leveraging international funding, interdisciplinary collaboration involving all key stakeholders, and frugal scientific design, development and evaluation.

Cystometrogram: the low-cost method for rural areas and its benefits.

Cystometrography (CMG) is a means of studying bladder pressure. It is a very useful diagnostic tool in patients with lower urinary tract symptoms for which a simple cystoscopy will not offer sufficient information to form a diagnosis. Of the 8893 patients who underwent screening for urological conditions in rural northeast India during 2010-2014, 280 with lower urinary tract symptoms were investigated with a combination of cystoscopy and CMG. By corresponding CMG diagnosis and treatment, we could examine patients' overall satisfaction with both the procedure and the treatment. We describe a low-cost method of CMG and our results using this method in rural areas of India.

Low cost endo-loop for rural surgeons.

Readymade endo-loops can make laparoscopic surgery convenient and faster. Commercially made endo-loops are expensive. We describe a method of making low-cost endo-loops from materials available in the operating room.

Laparoscopic surgery in middle- and low-income countries: gasless lift laparoscopic surgery.

INTRODUCTION: Surgically treatable conditions are an increasing burden in low- and middle-income countries, and recent studies suggest they have overtaken the "big three" (malaria, tuberculosis and HIV) as a cause of mortality. AIM: In this context, we have worked to modify standard laparoscopic equipment to allow laparoscopy in remote areas without support services such as bottled gases or disposable instruments. RESULTS: A simple and reliable system of gasless laparoscopy has been developed using robust reusable instruments, widening the potential availability of laparoscopic surgery in remote and rural areas. CONCLUSION: Our findings suggest that, using this equipment, appropriately trained surgeons can provide minimally invasive surgery in even the most remote locations.

Growth and characterization of Cadmium Thiosemicarbazide Bromide crystals for antibacterial and nonlinear optical applications.

Semiorganic nonlinear optical crystals of Cadmium Thiosemicarbazide Bromide was grown by slow evaporation solution growth technique. The unit cell parameters were estimated by subjecting the crystals to single crystal X-ray diffraction. The grown crystals were subjected to Powder X-ray diffraction for analyzing the crystalline nature of the sample. FTIR studies reveal the functional groups and the optical characters were analyzed by UV-Vis spectral studies. Mechanical stability of the sample was assessed by Vicker's micro hardness test. The presence of surface dislocations was identified by chemical etching technique. Antibacterial study was carried out against ACDP declared harmful pathogens. SHG efficiency of CTSB crystal was tested using Nd: YAG laser and it was found to be ∼1.8 times that of potassium dihydrogen phosphate.

Single-incision lift laparoscopic appendicectomy: a less expensive technique easy to learn.

Appendicectomy is the most common abdominal operation performed on an emergency basis in most parts of the world. The laparoscopic technique has many advantages over conventional open surgery especially in women and obese patients. A further improved version introduced recently is using a single-incision (SILS). Inducing a pneumoperitoneum, as a necessary precondition of laparoscopic procedures, represents a restriction of the surgeon's freedom of movement and can lead to typical though rare complications. Gasless laparoscopic surgery has most of the advantages of laparoscopic surgery without many of the disadvantages. It is also less expensive, and can be combined with regional anaesthesia. Furthermore, fewer disposable materials are necessary. We describe a series of single umbilical incision gasless laparoscopic appendicectomies performed in rural areas of India.

Salvaging a diabetic foot: a new cost-effective method.

The method that we use has an initial cost (£ 150) and uses fewer materials for dressing daily than other methods. It is easy to use at the extremities and is effective in preventing amputation in some diabetics.

The use of Hegar's dilator for finding correct planes around the uterus.

The Hegar's dilator could be used during both laparoscopic and open surgeries to find the correct planes to enter into either posterior or anterior fornix with minimal blood loss and with ease.

Ureterorenoscopic removal of renal stones: cost-effective patient friendly method in rural areas.

Treatment of moderate-sized renal stones is difficult; we describe here a simple noninvasive method of removing them using the ureterorenoscope, the lithoclast and prior Double 'J' stenting. This method was successful in 101 out of 133 patients.

Low-cost topical negative pressure wound dressing system.

Poorly healing wounds are a bane to any surgical unit, but particularly in rural areas, and require a lot of effort to manage. One of the most effective recent methods that has been described is the application of topical negative pressure. We describe here a simple system made from the locally available materials that achieves this effect.

Diagnostic laparoscopies in rural areas: a different use for the cystoscope.

Minimally invasive surgeries are gaining popularity even in rural areas. Diagnostic laparoscopies overcome the disadvantages of open surgical procedures and provide useful diagnostic information. We describe a method of carrying out diagnostic laparoscopies using the cystoscope in rural areas.

Healthcare planning in north-east India: a survey on diabetes awareness, risk factors and health attitudes in a rural community.

AIMS AND OBJECTIVES: To determine the level of awareness and knowledge about diabetes in the community, to identify their risk factors for diabetes, the relationship between anthropometric measures and diabetes risk and estimate the burden of diabetes in this rural North-East Indian population with an objective to identify target areas for future healthcare planning. MATERIALS AND METHODS: A healthcare team conducted a community-based survey of the residents of Khowai district, Tripura. All household members above the age of 25 years were eligible to participate, following voluntary consent. Survey questionnaires were administered with interpreter assistance including demographic information, diabetes knowledge, family history, smoking, diet, healthcare access and the international physical activity questionnaire (IPAQ). Anthropometric measurements were taken and blood glucose testing performed. RESULTS: One hundred and forty four participants completed the survey, 66 males and 78 females with a mean age of 44.4 +/- 14.8 years Although 91% had heard about diabetes and 44% were concerned about developing it in the future, only 39% were aware of its association with overweight status and 37% knew it required long-term treatment. Nine percent were known to have pre-existing diabetes mellitus and a further 9% were newly detected to have diabetes mellitus or impaired glucose tolerance. Fifteen percent were hypertensive and 8% had a family history of diabetes. Their mean BMI was 21.2 kg/m2 and 31% were overweight, despite high levels of physical activity in 47%. For each predictor of increased risk--waist circumference (female >80 cm, male >94 cm), waist-height ratio >50% or BMI>23 kg/m2, subjects measuring above the cut-off were more likely to have abnormal glucose tolerance than those in the normal range (27% vs. 14.3% p = 0.08, 26.5% vs. 9.5% p = 0.008, 27.3% vs. 13.3% p = 0.043, respectively.) with waist-height ratio being the best predictor of an abnormal BGL: OR 3.45 CI (1.34 - 8.88). CONCLUSION: This is the first rural survey for diabetes in North-East India. This population had a low baseline knowledge and awareness about diabetes, despite significant diabetes prevalence. A greater emphasis on health education and risk factor modification for diabetes is warranted in the North-East part of the country.

Endometrial resection/vaporization: a patient-friendly first-option treatment for menorrhagia in rural areas.

Hysterectomy, a major surgical procedure, is often an unacceptable procedure for many patients from rural areas who attend small rural hospitals. Near total endometrial resection/vaporization is a more acceptable procedure which can control menorrhagia. This procedure can be carried out with standard urology instruments.