Description of the Problem[edit | edit source]

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The disparity in the care of surgically-treatable conditions is epitomized by the treatment and clinical course of ectopic pregnancy throughout the world.  Ectopic pregnancy occurs in 1-2% of pregnancies worldwide and is the leading cause of maternal death in the first trimester.1  Additionally, ectopic pregnancy results in fetal loss of life and is associated with recurrence and impairment of fertility.2  The prevalence of ectopic pregnancy is higher in sub-Saharan Africa, ranging from 2-4%, with a maternal mortality rate between 1-2%, 10-fold higher than in high-income countries.2  Ectopic pregnancy is a significant contributor to the obstetrical morbidity and mortality in sub-Saharan Africa, which are the highest in the world.3

In high-income countries, stable patients without rupture are treated with laparoscopic salpingectomy or salpingostomy or methotrexate administration.4,5,6,7  However, in sub-Saharan Africa, patients, regardless of their hemodynamic status, are approached through midline laparotomy, a procedure with significant morbidity, starkly highlighting the treatment disparity.3  Though most patients in low-middle income countries present at a more advanced stage where hemodynamic compromise might necessitate an open approach, a large cohort of patients including stable patients with rupture may benefit from a less invasive technique.1  Early laparoscopy has also been suggested as a tool to accelerate diagnosis and therapy.8,9

Laparoscopic management of ectopic pregnancy has been shown to have significantly shorter operation time, perioperative blood loss, length of stay, and convalescence time compared to its open counterpart.5,10   At present, the lack of trainers, training equipment, and simulation – not cost or lack of equipment - has been identified as the greatest barrier towards the implementation of laparoscopy.11

Because of the potential to decrease morbidity and mortality for women who are critical to the success and vitality of nations, we chose to develop a module to teach the laparoscopic treatment of ectopic pregnancy.  With ALL-SAFE, African Laparoscopic Learners - Surgical Advancement For Ectopic pregnancy, learners become competent and confident in performing all aspects of patient care in the laparoscopic treatment of ectopic pregnancy.  Moreover, proficiency in this module confers a skillset that is applicable towards performance of laparoscopy in the resource-constrained setting in general, inclusive of common diseases such as appendicitis and perforated viscus which contribute to the staggering surgical burden of disease.

The program’s impact on patient care is being evaluated at our three sites: Soddo Christian Hospital in Ethiopia, AIC Kijabe Hospital in Kenya, and Mbingo Baptist Hospital in Cameroon, teaching sites that belong to the Pan-African Academy of Christian Surgeons (PAACS).  Currently, none of these hospitals regularly utilizes laparoscopy in the treatment of ectopic pregnancy.  At the one-year anniversary after the rollout of the pilot, pre- and post-intervention rates of laparotomy and laparoscopy for ectopic pregnancy will be compared to determine adoption of laparoscopy in the treatment of this condition.

The general benefits of laparoscopy over open surgery have been well-established and may be amplified in low-middle income countries where advances in infection rates, length of stay, and convalescence could translate into meaningful and scalable gains in health outcomes, economics, and healthcare utilization regionally and nationally.12

Procedure[edit | edit source]

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In the sections of the module dedicated to pre- and post-operative care, the learner is presented with a patient scenario of a woman with an ectopic pregnancy.  The learner is asked to recognize and assess symptoms and signs, order and interpret appropriate tests, initiate surgical management, and supervise post-operative care on a web-based interactive learning system.  The interactive simulation is intended to engage the learner through a scenario that is relevant, relatable, and representative with the learning occurring as the participant completes the module.

Consistent with adult learning, the material is presented in a case format that will appear immediately relevant and applicable to learners who can move at their own pace with unlimited iterations on a platform that is natural for the “digitally native” generation.13  By using a web-based platform, the simulation is not constrained by physical or time-based barriers.13  In order to overcome the oversimplification of a real living clinical scenario to one that is experienced as a web vignette, the scenario features rich clinical detail, graphics, and relevant supplementary data.13  Recognizing that internet connectivity may be the biggest limitation, the module has been designed to require austere internet data connectivity speeds.

Content is hosted on Rise, a readily-accessible, open-source learning management system.  All content is secured and meets all of the technical requirements of Sharable Content Object Reference Model (SCORM; Scorm.com), ensuring it is portable, reliable, and scalable.

The module is designed to take place in real-time with continuity between the clinical decision making and the performance of the operation.  By creating a comprehensive simulation that essentially covers learning from the initial clinical encounter to the post-operative recovery in a realistic patient simulation, the learner will graduate from the module with a complete roadmap.

Simulation[edit | edit source]

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Following the web-based component that targets knowledge and decision-making surrounding the diagnosis and management of ectopic pregnancy, the second component targets psychomotor skills.  Using a box trainer that can be constructed out of readily available materials innovatively utilizing a cellphone as the laparoscope and a computer as the monitor, the learner develops proficiency in the surgical management of ectopic pregnancy in a field emulating pelvic anatomy.  The learner participates in the sequential steps of a laparoscopic salpingostomy as well as practices and refines essential surgical skills including intracorporeal suturing and knot tying by watching paradigms performed by experts and guided by a validated skills checklist.  The ectopic model uniquely integrates technical skills needed to perform the operation (intracorporeal suturing) with the actual anatomic simulation (Fallopian tube in the pelvis).  The learner’s performance of the procedure is captured on video by the cellphone/laparoscope and can subsequently be self- and peer- assessed.  Because of the ease of reproducibility and low cost of the box trainer and the ectopic model, multiple iterations can be performed until proficiency is established.

The box trainer has also been designed to maintain force feedback capability and focal distance replication that are intrinsic to laparoscopic surgery.13,14,15  Although the box trainer and ectopic simulation are low-cost, the fundamental elements maintain high fidelity as the box trainer conceptually aligns with high-cost simulators available in high-income countries.  The box trainer has the additional unique and powerful feature of replication of a true 30-degree laparoscope view, which is preferred for safe and effective management of pelvic surgery.  Because the box trainer is constructed from cardboard, its longevity will be limited, but ease of build allows for ready replacement.

The learner’s acquired knowledge and surgical skills can then be directly applied in the operating room for safe and effective treatment of ectopic pregnancy.  Because the skills and steps are practiced in a complete, anatomic, case-based model, the learner is able to apply the acquired skills readily to patient care.

Assessment[edit | edit source]

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Assessment of knowledge and psychomotor skills is performed in a way that optimizes the learner’s time while providing meaningful feedback.  Proficiency in knowledge, specifically pre- and post-operative considerations, will be assessed through interactive questions built into the learning management system.  As learners engage in the clinical scenario vignette, they answer relevant questions authentic to the clinical presentation.  Immediate feedback will guide learners as they progress through the scenario, while pre- and post-training summed scores will be compared to assess the program’s impact on learner knowledge.  Learners are required to complete the scenario with 100% answers correct before advancing to the psychomotor skills.

Proficiency in the psychomotor (laparoscopic) skills is assessed through video by self- and peer-assessment using the ALL-SAFE assessment tool, a stepwise verification of proficiency checklist that aligns with the assessments used in the American College of Surgeons and Association of Program Directors in Surgery (ACS/ADPS) Resident Skills Curriculum,16 complemented by the global scale, a modified Global Operative Assessment of Laparoscopic Skills (GOALS) scale.17  The ALL-SAFE assessment will allow learners to easily identify performance gaps and assess overall improvement.

After completion of the simulation, learners upload the video of their performance to the learning platform to allow for immediate self-assessment and asynchronous peer review based on the ALL-SAFE assessment.  The web-based system enables peer review without time zone or geographical constraints.  Assessment and scoring for each unique learner profile supports learner tracking and feedback on individual progress, while a summary reporting feature will support program evaluation.  Ease of platform navigation, video optimization, and access to the assessment rubric promote timely feedback to the learner.  Attainment of competence to perform the procedure is determined by attaining a score threshold on the ALL-SAFE assessment.  The feasibility of utilizing video review through artificial intelligence which would allow for more immediate feedback is also being investigated.

Evaluation[edit | edit source]

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Both components of the full surgical module, the cognitive case scenario and the psychomotor skills component, have undergone multiple rounds of testing, improvements based on pilot feedback, and re-testing at all of our sites.  Following is a list of notable improvements to both components:

  1. Rewording of various pre-test and post-test questions as well as elements of case scenario to improve clarity of comprehension at pilot sites
  2. Improvement in dimensions of box trainer to better emulate pelvic cavity and realistic trocar positions for this procedure
  3. Improvements to ectopic model (fixation of model to table, use of a white paper background to emphasize contrast for visualization)
  4. Establishment of video connection between laparoscope/cell phone and monitor/computer through EpocCam and DroidCam (webcam) rather than Zoom, Skype, Facetime, or Facebook messenger which had prohibitive data transmission speeds at the pilot sites or were not readily available.
  5. Adjustment of recipe for playdough to simulate ectopic contents to improve realistic tactility, ectopic evacuation, and ease of use with laparoscopic graspers.
  6. Technical adjustments to platform including video optimization prior to video upload to accommodate slower data speeds
  7. Availability of all materials in PDF form to accommodate offline use and slower data speeds

Innovation[edit | edit source]

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ALL-SAFE is innovative as it builds on traditional laparoscopic training models.

  1. The teaching content is unified within the context of a clinical case that takes the learner from first encounter with a patient to post-operative recovery.  The all-inclusive comprehensive module is meant to allow for ready transfer of knowledge and psychomotor skills to a literal patient for the adult learner through the use of multiple teaching methods.
  2. The innovative box trainer unites manual skills with anatomy.  Current teaching modules such as the Fundamentals of Laparoscopic Surgery focus on psychomotor skill acquisition through performance of heterogenous manual tasks such as peg transfer or pattern cutting.21  ALL-SAFE focuses on clinically relevant skill acquisition (intracorporeal suturing and knot tying) on the actual anatomy (Fallopian tube).  Proper retraction and port placement are necessary as learners perform the sequential steps of the actual operation.
  3. ALL-SAFE includes teaching on other fundamental components mandatory for safe performance of the operation that may not be a part of conventional simulations including suitability for laparoscopy based on patient presentation and anesthetic considerations, patient positioning, and post-operative care.
  4. Surgeons learn how to perform this operation using the equipment that will be available to them in their austere clinical environments (monopolar electrocautery, intracorporeal suturing and knot tying), rather than equipment that is available in a high-income country (ultrasonic dissection).
  5. The simulation system is easily constructed from low-cost materials readily available in resource-constrained settings.  The design expands on previously published models22,23 by improving the dimensions to emulate the abdominopelvic cavity with higher fidelity.  Our box trainer also has the unique ability to utilize a 30-degree laparoscope view, the first such design to our knowledge.  The model innovatively uses a cell phone as the laparoscope and a computer as the monitor with an internet connection to most closely emulate a laparoscope and monitor.
  6. The use of a cellphone as a laparoscope allows for easy and automatic video recording of the procedure and skills development for assessment purposes.
  7. The simulation platform has been piloted at our sites with feedback for improvement and optimization incorporated in later iterations.
  8. While the module is not “high-tech,” it is innovative and can be practically implemented in low-resources centers for immediate use.

Users[edit | edit source]

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The learner population includes surgeons, gynecologists, and surgical and OB-GYN residents in low-middle income countries, a cohort which has strongly desired training in laparoscopy.11  We performed an internal needs assessment among all the program directors of PAACS and identified technical skills in laparoscopy as areas for which training and proficiency were strongly desired.24  Specific areas of current deficiency included knowledge in port placement, use of an angled laparoscope, and more advanced skills such as intracorporeal suturing and knot-tying.  These concepts are all covered within this module.  These individuals would already have experience in the conventional open management of ectopic pregnancy but would not likely have experience or skill to treat this diagnosis laparoscopically.  We have not experienced barriers to use for interested learners as the module is open source and the material to create the box trainer are universally readily available.

Looking Ahead: Future Modules[edit | edit source]

Appendicitis[edit | edit source]

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Our solution will allow surgeons to become confident and competent in performing all aspects of patient care (pre-, intra-, and post-operative) in the laparoscopic treatment of appendicitis in a resource-constrained setting.

Acute appendicitis is one of the most common causes of acute abdomen and the most frequent indication for emergency surgery worldwide.  The overall global incidence is 52 cases per 100,000 people.  In Africa, the prevalence is increasing, possibly due to the Westernization of diet.  Additionally, acute appendicitis is a more serious disease in the developing world, with increased morbidity and worse clinical outcomes.

The surgical treatment of appendicitis consists of open or laparoscopic appendectomy.  The laparoscopic approach has been shown to have a lower rate of wound infection, less pain on post-operative day one, and shorter duration of hospital stay.  These general benefits of laparoscopy over open surgery may be amplified in low-middle income countries where advances in infection rates, length of stay, and convalescence could translate into meaningful and scalable gains in health outcomes, economics, and healthcare utilization regionally and nationally.

A laparoscopic appendectomy is also, like laparoscopic salpingostomy, a procedure that confers a skillset that would be applicable to laparoscopy in general and is a good “starter” operation for learners.  This especially holds true when this procedure is done in the low-resource setting without use of surgical staplers or ultrasonic dissectors.  In this setting, the mesoappendix and appendiceal stump are ligated with endoloops or intracorporeal sutures and ties.

Small Bowel Resection and Anastomosis[edit | edit source]

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Our solution will allow surgeons to become confident and competent in performing all aspects of patient care (pre-, intra-, and post-operative) in the laparoscopic-assisted small bowel resection and anastomosis for small bowel tumor in a resource-constrained setting.

Bowel resection (enterectomy) and anastomosis is one of the most common surgical procedures performed worldwide.  The indications for bowel resection are numerous and include tumors, obstruction, inflammation, perforation, and bleeding.  In the low-resource setting, bowel resection is commonly performed for incarcerated hernia, trauma, and small bowel tumors.

This module will teach the general technique for laparoscopic-assisted small bowel resection and anastomosis which would be applicable in a myriad of diverse clinical situations.  Additionally, the principles of laparoscopic-assisted bowel resection would be applicable to the advancement of laparoscopy in general.  The psychomotor aspects of this procedure could be applied to more advanced laparoscopic procedures including laparoscopic right and left colectomy.

Penetrating Thoracoabdominal Trauma[edit | edit source]

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Our solution will allow surgeons to become confident and competent in performing all aspects of patient care (pre-, intra-, and post-operative) in the laparoscopic treatment of penetrating thoracoabdominal injury in the resource-constrained setting.

The incidence of occult diaphragmatic injury in the setting of penetrating thoracoabdominal trauma is as high as 43%.  Even with robust imaging options, a missed rate of occult traumatic diaphragmatic injury can be as high as 50% which can have devastating consequences to the patient in the acute and chronic setting.  In developed countries, hemodynamically stable patients with penetrating thoracoabdominal injuries are routinely approached laparoscopically which has been shown to be a safe diagnostic and therapeutic option.  Laparoscopic treatment of traumatic diaphragmatic injuries results in decreased morbidity and shorter hospital stay with a low conversion rate.  However, most patients in the low-resource setting are treated through exploratory laparotomy, an operation with significant morbidity and mortality.

The adoption of laparoscopy for the evaluation and treatment of penetrating thoracoabdominal trauma resulting in diaphragmatic injury would significantly decrease the morbidity for these patients who currently undergo exploratory laparotomy.  While this module will address the specific surgical management of a diaphragmatic injury laparoscopically, the technical principles taught in this case (diagnostic laparoscopy, exposure, running small bowel, and intracorporeal suturing) are widely applicable towards advanced laparoscopy.  Small bowel injury is also a common problem with penetrating trauma.  This module will build off of the acquired skills from previous modules allowing the learner to address multiple intraabdominal traumatic injuries successfully.

References:

1. Lawani OL, Anozie OB, Ezeonu PO. Ectopic pregnancy: a life-threatening gynecological emergency. Int J Womens Health. 2013;5:515-521. doi:10.2147/IJWH.S496723.  Goyaux N, Leke R, Keita N, Thonneau P. Ectopic pregnancy in African developing countries. Acta Obstetricia et Gynecologica Scandinavica. 2003;82(4):305-312. doi:10.1034/j.1600-0412.2003.00175.x

2.  Goyaux N, Leke R, Keita N, Thonneau P. Ectopic pregnancy in African developing countries. Acta Obstetricia et Gynecologica Scandinavica. 2003;82(4):305-312. doi:10.1034/j.1600-0412.2003.00175.x

3.  Onibokun O, Boatin A, Diouf K. The Role of Minimally Invasive Gynecologic Surgery in Sub Saharan Africa. Curr Obstet Gynecol Rep. 2016;5(4):333-340. doi:10.1007/s13669-016-0184-9

4.  ACOG Practice Bulletin No. 191: Tubal Ectopic Pregnancy. Obstetrics & Gynecology. 2018;131(2):e65. doi:10.1097/AOG.0000000000002464

5.  Hajenius PJ, Mol F, Mol BWJ, Bossuyt PM, Ankum WM, Veen FV der. Interventions for tubal ectopic pregnancy. Cochrane Database of Systematic Reviews. 2007;(1). doi:10.1002/14651858.CD000324.pub2

6.  Barnhart KT. Ectopic Pregnancy. New England Journal of Medicine. 2009;361(4):379-387. doi:10.1056/NEJMcp0810384

7.  D’Hooghe T, Tomassetti C. Surgery for ectopic pregnancy: making the right choice.  The Lancet. 2014;383(9927):1444-1445. doi:10.1016/S0140-6736(14)60129-X

8.  Domínguez LC, Sanabria A, Vega V, Osorio C. Early laparoscopy for the evaluation of nonspecific abdominal pain: a critical appraisal of the evidence. Surg Endosc. 2011;25(1):10-18. doi:10.1007/s00464-010-1145-4

9.  Chao TE, Mandigo M, Opoku-Anane J, Maine R. Systematic review of laparoscopic surgery in low- and middle-income countries: benefits, challenges, and strategies. Surg Endosc. 2016;30(1):1-10. doi:10.1007/s00464-015-4201-2

10. Saleh AM, Mahjoub MM, El-Kurdy AM. Laparoscopy versus laparotomy management of tubal pregnancy. Saudi Med J. 2001;22(9):771-775.

11. Robertson F, Mutabazi Z, Kyamanywa P, et al. Laparoscopy in Rwanda: A National Assessment of Utilization, Demands, and Perceived Challenges. World J Surg. 2019;43(2):339-345. doi:10.1007/s00268-018-4797-1.

12. Rosenbaum AJ, Maine RG. Improving Access to Laparoscopy in Low-Resource Settings. Ann Glob Health. 85(1). doi:10.5334/aogh.2573

13. Willis RE, Peterson RM, Dent DL. Usefulness of the American College of Surgeons’ Fundamentals of Surgery Curriculum as a knowledge preparatory tool for incoming surgery interns. The American Journal of Surgery. 2013;205(2):131-136. doi:10.1016/j.amjsurg.2012.11.001

14. Lamata P, Gómez EJ, Sánchez-Margallo FM, Lamata F, del Pozo F, Usón J. Tissue consistency perception in laparoscopy to define the level of fidelity in virtual reality simulation. Surg Endosc. 2006;20(9):1368-1375. doi: 10.1007/s00464-004-9269-z

15. Bholat OS, Haluck RS, Murray WB, Gorman PJ, Krummel TM. Tactile feedback is present during minimally invasive surgery 1. Journal of the American College of Surgeons. 1999;189(4):349-355. doi:10.1016/S1072-7515(99)00184-2

16. American College of Surgeons and Association of Program Directors in Surgery (ACS/ADPS) Surgery Resident Skills Curriculum https://www.facs.org/education/program/resident-skills. Accessed October 8, 2020.

17. Vassiliou MC,  Feldman LS,  Andrew CG, Bergman S, Leffondré K, Stanbridge D,  Fried GM. A global assessment tool for evaluation of intraoperative laparoscopic skills Am J Surg. 2005 Jul;190(1):107-13. doi: 10.1016/j.amjsurg.2005.04.004.

18. American Educational Research Association, American Psychological Association, & National Council on Measurement in Education. (2014). Standards for educational and psychological testing. Washington, DC: American Educational Research.

19. Cook DA, Brydges R, Zendejas, Hamstra SJ, Hatala R, Technology-Enhanced Simulation to Assess Health Professionals: A Systematic Review of Validity Evidence, Research Methods, and Reporting Quality. Academic Medicine, June 2013, 88(6): 872-883.

20. Haladyna, T.M., & Rodriguez, M.C. (2013). Developing and validating test items. New York, NY: Routledge.

21. Sroka G, Feldman LS, Vassiliou MC, Kaneva PA, Fayez R, Fried GM. Fundamentals of Laparoscopic Surgery simulator training to proficiency improves laparoscopic performance in the operating room—a randomized controlled trial. The American Journal of Surgery. 2010;199(1):115-120. doi:10.1016/j.amjsurg.2009.07.035

22. Gheza F, Oginni FO, Crivellaro S, Masrur MA, Adisa AO. Affordable Laparoscopic Camera System (ALCS) Designed for Low- and Middle-Income Countries: A Feasibility Study. World J Surg. 2018;42(11):3501-3507. doi:10.1007/s00268-018-4657-z

23. Van Duren B, Boxel G. Use your phone to build a simple laparoscopic trainer. Journal of Minimal Access Surgery. 2014;J Minim Access Surg.:219–220. doi:10.4103/0972-9941.141534

24.  Addiss DG, Shaffer N, Fowler BS, Tauxe RV. The epidemiology of appendicitis and appendectomy in the United States. Am J Epidemiol. 1990 Nov;132(5):910 doi: 10.1093/oxfordjournals.aje.a115734. PMID: 2239906.

25. Kong VY, Sartorius B, Clarke DL. Acute appendicitis in the developing world is a morbid disease. Ann R Coll Surg Engl. 2015 Jul;97(5):390-5. doi: 10.1308/003588415X14181254790608. PMID: 26264094; PMCID: PMC5096553.

26. Oguntola AS, Adeoti ML, Oyemolade TA. Appendicitis: Trends in incidence, age, sex, and seasonal variations in South-Western Nigeria. Ann Afr Med. 2010 Oct-Dec;9(4):213-7. doi: 10.4103/1596-3519.70956. PMID: 20935419.

27. Koto, Z.M., Mosai, F. & Matsevych, O.Y. The use of laparoscopy in managing penetrating thoracoabdominal injuries in Africa: 83 cases reviewed. World J Emerg Surg 12, 27 (2017). https://doi.org/10.1186/s13017-017-0137-2

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Keywords ALL-SAFE
Authors ALL-SAFE Team
Published 2021
License CC-BY-SA-4.0
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