The Responsible Use of Minimally Invasive Surgery in Remote Areas of Brazil: Feasibility and Safety of a Temporary Gynecologic Operative Expedition

Abstract

Objective: To evaluate the feasibility and safety of a novel model for providing minimally invasive surgical (MIS) care to underserved populations. Design: A prospective pilot study with patients affected by diverse benign pathologies of the female urogenital tract undergoing MIS in the context of a temporary expedition. Methods: In 2013, the Bandeira Científica Project implemented the use of MIS in one of the most underserved areas of Brazil. Results: During 4 days, 54 different procedures were performed on a cohort of 30 selected women. The mean age of the patients was 44.5 years (SD 8.3), while body mass index averaged 28.4 kg/m² (SD 4.3). The primary indications for surgery were as follows: 14 symptomatic uterine leiomyomatosis/adenomyosis, 6 stress urinary incontinence, 6 endometriosis, and 4 pelvic floor defects. Forty percent of the patients underwent laparoscopy, 53% vaginal surgery, and 7% combined procedures. The mean estimated blood loss and operative time were 148 cc (0–1000) and 94 (24–180) minutes, respectively. No casualty or conversion to laparotomy occurred. The median hospital stay was 1 day (1–2). Significant complications occurred in two cases (6%); one postoperative bleeding and one pelvic infection. A satisfaction survey revealed that 100% of the participants were very satisfied. Conclusion: This series demonstrates that it may be feasible and secure to establish temporary MIS services in remote/distant locations. The correct selection of local facilities allied to the provision of modern equipment and experienced surgeons is essential to guarantee safety for patients. (J GYNECOL SURG 31:255)

Introduction

Despite unequivocal benefits provided by minimally invasive surgery (MIS) for the treatment of diverse benign gynecologic conditions, the capacity to provide access to such modern medical technology is a major issue for a large number of developing nations.^1–4 In this part of the world, delivery of advanced healthcare is always challenging due to the absence of adequate infrastructure and limited financial resources.^5,6

The high initial costs to acquire equipment allied to restricted access to surgical training are major obstacles to the implementation of MIS in underprivileged areas. The existence of a complex and expensive infrastructure is crucial for providing the technical feasibility while preserving the safety of the patients. This situation leads, for example, to a higher percentage of abdominal in comparison to vaginal or laparoscopic hysterectomies. To illustrate, the abdominal hysterectomy rate in the United States in 2009 was 64% in comparison to ∼90% in Brazil during the same period.^7,8

Surgery is considered a highly specialized medical field that requires long years of training and qualification.⁹ Responsible surgical care demands trained doctors to provide safe operative and anesthesia services. In the developing world, there is a shortage of quality professionals as a consequence of limited medical education and exchange programs especially with regard to endoscopic procedures.⁵

To overcome such challenges and promote the widespread use of minimally invasive techniques, a protocol was established to provide MIS care in an underserved area in Brazil while offering an educational program. The Bandeira Científica Project (BCP), funded by the University of São Paulo Medical School, has delivered healthcare services to underprivileged populations in Brazil since 1957. In 2013, BCP developed a mobile surgical expedition that was conducted with adequate infrastructure and experienced medical staff. The aim of the present study is to determine the feasibility and safety of this protocol in establishing a surgical mission given the local resources.

Patients and Methods

The object of this initiative was to offer state-of-the-art surgical therapies to women with benign gynecologic conditions and restricted access to medical care. A structured educational program, which focused on the teaching of minimal invasive techniques to medical students, residents, and local doctors, was an integral part of the mission. The collected data will be useful for designing future strategies for healthcare policies in Brazil.

The design of the project was structured according to the following steps (Table 1).

Table 1.

Summary of the Most Important Technical Aspects of the Project

Essential aspects of the protocol
• Location selection based on availability of hospital facilities
• Financial support: partnership with industry and government
• Involvement of an experienced medical/surgical staff
• Provision of modern surgical equipment
• Precampaign patient screening visit
• Use of advanced sonography techniques for patient triage
• Strict patient selection criteria: low risk (ASA<II), benign pathology
• Educational program to local professional and medical students

Selection of city and hospital facility

Initially, a careful search was developed to select a city with a low Human Development Index (HDI) in a remote area of Brazil, based on the availability of essential medical/surgical infrastructure. A pre-campaign inspection visit was organized, in which the healthcare facilities were evaluated. After selection of a potential hosting site, the concept of a temporary surgical expedition was presented to the local authorities who needed to embrace the protocol. The Regional Hospital Dr. Alvaro Fontoura Silva in the city of Coxim in the state of Mato Grosso do Sul was selected for the project. Geographically, the municipality of Coxim is ∼1500 km from the cities of São Paulo and Rio de Janeiro. The location has a current population of 32,159 and an HDI of 0.703.¹⁰

Financial support and partnership with local industry and government

The project was financed by the University of São Paulo in partnership with sponsors Sanofi; Mindray; Karl Storz and Covidien. These institutions delivered supplies for the surgical mission consisting of medical and nonmedical items. A large variety of laparoscopic, vaginal, and laparotomic surgical instruments, as well as ultrasound equipment, were ceded to the campaign. Some weeks before the beginning of the activities, the equipments were transported by truck from São Paulo to the site of the expedition and were set up in the local hospital.

Establishment of surgical team and medical students

Six board-certified gynecologists, including an international faculty well-versed with mission projects, two residents in obstetrics and gynecology (Ob/Gyn), five anesthesiologists, two pathologists, two radiologists, and two scrub nurses composed the staff. Five medical students (MS) and official members of the Bandeira Científica Project from the University of São Paulo Medical School designed and organized the expedition. After a selection process based on academic performance, seven other MS from the same institution were included in the expedition. None of the participants received any financial compensation for their activities.

Selection of patients

After the ethics board review approval (Plataforma Brasil 18123213.7.0000.0065), we conducted an on-site screening visit in May 2013. During this opportunity, a group composed of two consultant gynecologists, three radiologists, and two MS evaluated 80 women with potential indication for surgery due to benign gynecologic pathologies. These patients were inhabitants of the region identified by the local doctors along 6 months before the expedition. They underwent clinical evaluation, pelvic examination, transvaginal ultrasonography, and cervical cytology to exclude possible malignancies and to confirm the indication for surgery. Inclusion criteria were as follows: (a) absence of clinical, radiologic, or cytologic signs for malignancy; (b) age >18 years and <65 years; and (c) low anesthetic risk (ASA<II).¹¹ All the patients demonstrated significant impairment of their quality of life and had no other prospect of receiving adequate surgical therapy in the short term. After the identification of the subjects who fulfilled the inclusion criteria, each case was discussed to decide the most appropriate operative procedure.

Program of the expedition: surgical and educational activities

The period needed for the preparation and organization of the mission was 6 months, and the expedition itself was at the location for 8 days. All the patients were reevaluated to confirm the surgical indication. The surgeries were performed in the 4 following days so that the postoperative (PO) course of the patients could be followed during the remaining period of the initiative.

In parallel to the clinical activities, an educational symposium in MIS was organized. Aiming for an exchange of knowledge, the specialists presented several lectures and seminars to the MS, the local doctors, and health workers. Operative training in MIS with digital simulators was developed in a mobile facility. The students and the local personnel were directly instructed in hands-on activities by the consultant gynecologists.

With the aim of enhancing medical education, emphasis was given to providing practical experience for the MS. During the expedition, the MS actively participated in all surgical procedures, from anesthesia to PO care. They were constantly supervised in their clinical activities.

Outcome parameters

Patient outcomes and satisfaction rates

The following preoperative information was collected: the age of the patients and the body mass index (BMI) at diagnosis. Analyzed intraoperative (IO) data were as follows: the executed procedure(s), surgical route, estimated blood loss (EBL), operating time, and IO complications. Finally, PO results were also documented: the final pathology, hospital stay, and short and late PO complications. The continuous variables are presented as means and SDs (standard deviations), while the categorical variables are presented as numbers of cases or percentages. The surgical PO complications were classified in five different grades (I–V) according to Dindo et al.¹² Significant morbidity was considered grade ≥2.

All the operated patients were evaluated 7 days and 4 months after the intervention with the intention of detecting complications and to access operative and anatomic outcomes. To evaluate the patients' satisfaction with the procedures, all participants were asked to complete a PO questionnaire based on a semantic and visual scale, namely, very satisfied, quite satisfied, quite unsatisfied, or very unsatisfied.¹³

Medical students' learning experience

The participating MS were asked to objectively evaluate this extramural immersive experience by completing a postcampaign questionnaire based on a semantic scale of grades (0 low–5 high) given to three particular activities: surgery, anesthesia, and PO care.

Results

The surgical mission occurred in April 2013. During the period of the study, 30 women with different gynecologic conditions fulfilled the inclusion criteria and were operated on, utilizing diverse minimally invasive techniques. The epidemiologic and clinical features of the included patients are summarized in Table 2. The mean age of the patients at the time of intervention was 44.52 years old (SD 8.3), while BMI was on average 28.4 kg/m² (SD 4.3).

Table 2.

Epidemiologic Features of the Operated Patients

Mean age (years)	44.52 (SD 8.3)
Mean BMI (kg/m²)	28.42 (SD 4.3)
Primary preoperative diagnoses
Uterine leiomyomatosis	13 (44%)
Stress urinary incontinence	6 (20%)
Endometriosis	5 (17%)
Symptomatic cystocele	2 (7%)
Vaginal vault prolapse	1 (3%)
Uterine adenomyosis	1 (3%)
Chronic pelvic pain	1 (3%)
Second-degree perineal tear	1 (3%)

BMI, body mass index.

The primary preoperative diagnoses of the patients were as follows (Table 3): l4.4% (13) uterine leiomyomatosis, 20% (6) stress urinary incontinence, 17% (5) endometriosis, 7% (2) symptomatic cystocele, 3.3% (1) vaginal vault prolapse, 3.3% (1) uterine adenomyosis, 3.3% (1) chronic pelvic pain, and 3.3% (1) second-degree perineal tear. The total number of procedures was 54, including 10 vaginal hysterectomies, 4 total laparoscopic hysterectomies (TLH) with bilateral salpingo-oophorectomy, 4 TLH with bilateral salpingectomy, 7 midurethral slings, 4 cystocele repairs, 4 rectocele repairs, 3 cystoscopies, 3 endometriosis excisions, 2 diagnostic laparoscopies, 1 laparoscopic adhesiolysis, 1 vaginal vault prolapse repair, and 1 perineoplasty (Table 4). Among the operated patients, 12 (40%) underwent laparoscopy, 16 (53%) vaginal surgery, and 2 (7%) had a combined procedure.

Table 3.

Operative Outcomes, Including Patients' Satisfaction Survey

Procedures performed
Total hysterectomy	10
Sling TVT/TVTO	7
Hysterectomy with salpingo-oophorectomy	4
Hysterectomy with salpingectomy	4
Cystocele repair	4
Rectocele repair	4
Cystoscopy	3
Endometriosis excision	3
Diagnostic laparoscopy	2
Vaginal vault prolapse repair	1
Perineoplasty	1
Adhesiolysis	1
Total	54
Surgical route (%)
Vaginal	53%
Laparoscopic	40%
Combined (vaginal/laparoscopic)	7%
Mean operating time (minutes)	93.9 (24–180)
Mean estimated blood loss (cc)	148.3 (0–1000)
Median hospital stay (days)	1 (1–2)
Satisfaction survey	n=30
Very satisfied	30
Quite satisfied	0
Very unsatisfied	0
Quite unsatisfied	0
Follow-up (months)	4

Table 4.

Postoperative Relevant Complications (Grade ≥2), According to Dindo Et Al. Classification ¹²

Characteristic	N	%	Grade
Pelvic infection treated with oral antibiotics	1	3.3	2
Reoperation for bleeding	1	3.3	3
Total	3	6.6

No casualties, IO complications, or conversions to laparotomy occurred. One patient submitted to vaginal hysterectomy developed intra-abdominal bleeding. She was laparoscopically reoperated and the source of bleeding was identified and successfully managed. No blood transfusion was necessary and the EBL in this case was 1000 cc. The mean EBL, including the above-mentioned complication, was 148 cc (0–1000). The mean operative time was ∼94 minutes, ranging from 24 to 180 minutes. The median hospital stay was 1 day (1–2).

Among the operated women, we observed only one case of pelvic infection, which was treated by oral antibiotics. After histopathologic analysis of the pertinent specimens, no case of malignancy was detected. In the late reassessment (4 months later), all patients (30) were evaluated and no relevant complication was observed.

A satisfaction survey was completed by 100% of the participants and all women reported significant improvements in their previous symptoms and were very satisfied with the intervention. The majority of these women described positive psychologic and physical effects after surgery, such as enhanced self-esteem. Data concerning the operative outcomes and details related to surgical complications are shown in Tables 3 and 4, respectively.

With regard to medical education, the postexpedition survey was completed by 11 students (85%) and the mean grade given to all different activities was 4.1. The stratified evaluation revealed a mean grade of 3.9 (SD±0.54) for surgical activities, 4.7 (SD±0.46) for anesthetic procedures, and 3.1 (SD±1.1) for the PO care.

Discussion

The provision of essential surgical care is clearly inadequate in most low-income countries.¹⁴ Recently, there have been a number of initiatives aimed at integrating intensive surgical camps or missions into health systems such as the Global Initiative on Emergency and Essential Surgical Care (GIESSC),¹⁵ the WHO Integrated Management of Emergency and Essential Surgical Care, and the Italian NGO Comitato Collaborazione Medica (CCM).⁶ Available data show that as good standards of surgical care are utilized, this may be a safe strategy for providing operative therapy for benign conditions.⁵

Irrespective of the economic growth recently experienced by many countries in South America, there are fundamental differences between the developed and developing countries in terms of the availability of quality medical care. First, due to the great demand and the limited local resources, many patients need to be referred to medical centers located in large metropolises to receive essential surgical therapy. The delay in implementation of operative treatment leads to an impairment of the patient's quality of life and represents a relevant economic burden. The availability of healthcare facilities for dispersed populations is not likely to change in the near future; consequently, redesign of these services is urgently needed. Our study gives new insights for overcoming this situation and demonstrates that surgery for benign conditions in low-risk patients may be safely delivered.

After the introduction of operative MIS into clinical practice, a number of gynecologic conditions are preferably endoscopically or vaginally treated rather than with open surgery.¹⁶ Local general hospitals and even referral services in Brazil have been slow to follow this trend because of the large initial investments required for the acquisition of equipment and the dearth of highly trained surgeons and anesthetists. On the other hand, endoscopic expertise is normally concentrated in university centers situated in urban areas that rarely interact with local healthcare services. In contrast to previously published initiatives, the present reported experience substantiates the fact that modern surgical techniques can be safely brought to remote regions.

Medical ethics highlight the necessity of providing the best standard of care to patients irrespective of location.¹⁷ Patients should ideally be treated as close to their homes as possible to avoid unnecessary relocations.⁹ The absence of available strategies concerning the temporary use of sophisticated gynecologic surgery in underserved communities have motivated us to study a viable alternative to provide on-site services.

Due to the lack of data, it is difficult to evaluate the demand on gynecologic procedures in Brazil. A number of women affected by different gynecologic conditions remain physically, economically, and socially handicapped due to the inadequate services. Our project made possible the treatment of women with the best available resources and executed by qualified professionals. Notably, the observed overall complication rate in the present series was significantly low. In our opinion, the incorporation of endoscopic surgery in underprivileged areas is only possible with the implementation of the above-mentioned preconditions.

The choice of having a constant flow of surgery performed by surgeons in well-equipped facilities is not financially realistic in distant locations.¹³ The implementation of temporary MIS services may represent a viable alternative to solve the problem of the unmet demand for gynecologic surgery. Despite the fact that the presented strategy utilizes advanced technology, unequivocal benefits, such as shorter hospital stays and early return to normal activities, might compensate for the investments. Logistic optimization, including the decrease in the necessity for patients' transportation, may also contribute to reducing costs.

Possible positive psychologic effects of the minimally invasive procedures in these populations are seldom discussed in the literature. The present study is one of the few that has looked carefully at this aspect and observed that the operated patients were highly satisfied with the treatment. A number of women referred to enhanced self-esteem and improved quality of live after operation.

One of the major issues regarding medical education is surgical teaching. Instruction in endoscopic procedures demands innovative strategies to connect MS and residents with modern methods. The experience reported here included the provision of quality medical education through active participation in surgical procedures and through seminars and instruction in MIS. The surgical training for residents in many developing countries cannot be completely performed in teaching hospitals, as these facilities are frequently understaffed and have poorly maintained equipment.⁶ In our opinion, extramural immersive activities for MS and residents may play, in the near future, an important role in surgical specialization.

In conclusion, temporary surgical expeditions to the underprivileged areas aiming to perform sophisticated operations on low-risk patients with benign gynecologic conditions appear to be feasible and safe. The participation of experienced surgeons, the use of quality equipment, and the provision of adequate infrastructure are paramount to obtaining acceptable morbidity. We believe that the strategy described here may be extremely beneficial for a great number of women who would otherwise have a long wait for gynecologic interventions but deserve the best standard of care irrespective of location. Despite the fact that financial expenses of these mobile MIS services were not addressed in this article, they are apparently cost-effective and affordable by developing economies. Our data also support the view that surgical expeditions with educational purposes may be effective for MS, residents, and local professionals. Future studies and initiative are needed to attest the safety of this strategy and to consider financial aspects in more detail.

Footnotes

Acknowledgments

The authors are very grateful to all the other participants in the mission, namely Joaquim Edson Vieira, MD, PhD, Julia Zavariz, MD, Lidia Myung, MD, Ligia Lopes, MD, Luiz Fernando Ferraz da Silva, MD, Manoel Orlando, MD, Maria Candida Baracat, MD, Mario Junqueira D Avila, MD, Marta Privato, Karina Elmaes, Vivian Curcio, Adolfo Sasaki, Ananda Ise, Fernanda Terzi, Gisela Llobet, Liege Gomes, Mariana Herig, Rafael Vilares, and Rebecca Rossener.

Disclosure Statement

No competing financial interests exist.

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