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Robotic Assisted Laparoscopic Surgery in Gynaecology in the South African setting

Robotic Assisted Laparoscopic Surgery

1. Introduction

During the past 15 years, minimally invasive surgery (MIS) has become the standard of surgical treatment for almost all benign and malignant gynaecological conditions. It is widely accepted that MIS reduces hospital stay, is associated with less pain, and morbidity, and is associated with a quicker recovery and return to normal function.

The first robotic-assisted laparoscopic (RAL) surgery system (Da Vinci Surgical System, Intuitive Surgical, Sunnyvale, California) was approved by the US Food and Drug Administration in 2000 for general laparoscopic procedures, and in 2005 for gynaecological conditions. Since then there has been a rapid and wide uptake of the use of this system in the USA and Europe, resulting in major changes in the surgical care of women with gynaecological malignancies.1 Before the availability of RAL in these settings, most women underwent laparotomy procedures, with few women benefitting from standard laparoscopic (SL) surgery. Limitations impeding the uptake of SL surgery include limitation of instrument movement, two-dimensional view, difficult hand-eye coordination, the fulcrum effect, as well as physical strain and discomfort for the surgeon.2-3

In the rest of the world, the discipline of Gynaecology is the single largest user of the robotic platform.4

2. Gynaecological indications for the use of the Robotic platform

2.1 Endometrial Cancer

Although cervical cancer is the most common gynaecological cancer in South African women, endometrial cancer is the most common gynaecological cancer in women appropriately screened for cervical cancer, which largely reflects the majority of the female population in the private health care system in South Africa. Endometrial cancer is mainly a disease of post-menopausal women, is strongly associated with obesity, and these women frequently have co-morbidities such as type 2 diabetes mellitus and hypertension with its associated risks.

Endometrial cancer is surgically staged, and the primary modality of treatment is surgery. After staging and risk stratifying of early-stage patients, adjuvant treatment in the form of whole pelvic radiation therapy or vaginal brachytherapy or systemic chemotherapy or combinations thereof is offered as indicated. The surgical treatment of endometrial cancer consists of hysterectomy, removal of both ovaries, pelvic lymphadenectomy with or without para-aortic lymphadenectomy, or alternatively, pelvic sentinel lymph node biopsy using indocyanine green (ICG). The internationally accepted standard of care for surgical treatment is minimally invasive surgery (MIS), using either robotic-assisted laparoscopy (RAL) or standard laparoscopy (SL).5

Women diagnosed with endometrial hyperplasia with atypia or endometrial carcinoma in situ will also fall in this category, as up to 37% of these women will have invasive endometrial carcinoma diagnosed on the final histology of the uterus.6

2.2 Cervical Cancer

With regards to cervical cancer, the standard treatment for operable disease at this point is open radical hysterectomy, as it has superior outcomes compared to radical hysterectomy performed through MIS.7 However, there is a subset of women who are candidates for laparoscopic hysterectomy, trachelectomy and/or sentinel lymph node biopsy or lymphadenectomy. This includes women undergoing fertility-sparing procedures and women who had pre-operative conization for small tumours.8

Lymphadenectomy via MIS is also preferred to confirm nodal spread suspected on imaging in selected cases and to address adnexal masses prior to radiation therapy due to a reduction in adhesion formation.

2.3 Ovarian Cancer

There is a subset of women with stage 1 ovarian cancer who will benefit from MIS for staging purposes, and the surgery will consist of hysterectomy, bilateral salpingo-oophorectomy, omentectomy and pelvic with or without para-aortic lymphadenectomy. MIS is also appropriate for completing staging surgery for unstaged patients. Selected solitary recurrences especially in the upper abdomen can be removed by MIS with reduced morbidity.

2.4 Endometriosis

Endometriosis affects 1 in 10 women and has proven to be poorly managed by surgeons probably because of the complexity of the disease process and the long learning curve to master traditional laparoscopy.

The learning curve to train laparoscopic versus robotic surgeons has been shown to be shorter for robotics. A randomised controlled trial showed a shorter uptake time with robotic surgery versus laparoscopic surgery (GALL 2020) which should result in fewer errors during the traditional learning curve and hence improved patient outcome. (Leijte E, de Blaauw I, Van Workum F, Rosman C, Botden S. Robot-assisted versus laparoscopic suturing learning curve in a simulated setting. Surg Endosc. 2020 Aug;34(8):3679-3689. doi: 10.1007/s00464-019-07263-2. Epub 2019 Nov 21. PMID: 31754849; PMCID: PMC7326898.) A recent systematic review showed shorter operating times and even lower complications in the robotic arm. (Flynn 2021)

Advanced endometriosis surgery is possibly the most complex surgery to master. Robotic-assisted surgery for ASRM stage 3 and 4 endometriosis cases offers several advantages for both patients and surgeons. The superior 3D vision, precision and obvious ergonomic advantages of robotic-assisted laparoscopic surgery make it particularly beneficial in managing severe endometriosis cases.

One specific advantage is the use of indocyanine green fluorescence angiography during surgery. This helps in assessing the vascularization of ureters and bowel anastomosis, which can be crucial in preventing postoperative complications such as leakage. By providing real-time imaging, this technique improves the accuracy and safety of the surgical procedure. (lanieri 2021, Cela 2021)

Moreover, advanced endometriosis cases often require lengthy and complex surgeries. The use of robotics can make the surgical procedure easier for the surgeon, less physically demanding, and therefore more efficient.

It is strongly recommended that advanced endometriosis cases only be done at dedicated endometriosis centres with high volume cases. SASGE recommends that such centres perform a minimum of 2 cases per week of advanced stage 3/4 endometriosis. SASGE recommends that the surgeon should ideally have performed 40 advanced cases under the supervision of a recognised proctor and include a multi-disciplinary team skilled in performing endometriosis surgery.

2.5 Sacrocolpopexy

The same issues described for the treatment of endometrial cancer are valid for surgical treatment of pelvic organ prolapse. MIS procedures have the same outcomes compared to open surgery. Because of the complexity of the procedure, SL has not gained any momentum in this field. RAL MIS for organ prolapse has also resulted in an increase in the MIS for organ prolapse, with the procedure reported to be cost-effective compared to open surgery, but not SL.9

3. Benefits of robotic-assisted laparoscopy

The efficacy and safety of this platform have been well established, as it is the most used platform for MIS for women in Europe and in the USA.

3.1 Cost-effectiveness

The cost of RAL in women with endometrial cancer in South Africa should be compared to the cost of open surgery performed on women with endometrial cancer in South Africa, as the vast majority of these women are undergoing open surgery. Comparing the cost of RAL to that of SL will not provide the appropriate bigger picture, as there is not more than five gynaecologic oncologists currently performing SL MIS for women with endometrial cancer in South Africa. Data from the USA show a similar perioperative 30-day total cost when open surgery is compared to RAL for endometrial cancer.10-11

As already alluded to, most of these cases in SA are done by the laparotomy route. This results in longer hospital stays and more morbidity. It is, therefore, reasonable to suggest that if more women are treated with RAL compared to open surgery, it will inevitably result in, if not a saving in costs, at least not an increase in overall cost.

3.2 Robotic surgery increases the uptake of MIS

One of the most important effects of the robotic platform is certainly that of resulting in significant uptake of MIS by open surgeons not previously performing standard laparoscopic procedures, with a consequent drop in the percentage of open surgery. Over time, there has been a larger uptake of MIS through the robotic platform compared to conventional laparoscopy. The main drivers for this are the shorter learning curve and probably the added improved surgeon ergonomics provided by the robotic platform.

Data from the USA have shown a 43% (from 27.6% in 2008 to 70.6% in 2015) increase in the proportion of women undergoing treatment for uterine cancer. In one study, endometrial cancer treatment showed an absolute increase of 47.3% (from 9.5% in 2008 to 56.8% in 2015), with a 42.3% absolute decrease in open surgery. Similar to the situation in SA, SL surgery for endometrial cancer rates in the USA have remained static at around 17% of all procedures.10 In one institution, after the introduction of the robotic platform, the rate of minimally invasive surgery increased from 17% performed by laparoscopy to 98% performed on the robotic platform over a period of two years in the treatment of uterine cancer with an overall lower cost compared to open surgery.11

3.3 Improved ergonomics for the surgeons performing MIS

The one important part of the equation that is frequently ignored in the cost-related discussions around MIS, is that of ergonomics. The disadvantages to the physical well-being of surgeons performing complex MIS procedures, especially on obese women, have been well described. The available evidence suggests robotic surgery has drastically decreased musculoskeletal fatigue over time in surgeons and perhaps improves overall productivity and longevity of practice.12-15

3.4 Robotic Surgery in the Public Sector in South Africa

In the public sector, both Tygerberg Hospital and Groote Schuur Hospital have introduced robotic surgery. Robotic surgery can bring several benefits to both surgeons and patients. (https://www.westerncape.gov.za/news/tygerberg-hospital-first-government-institution-perform-robotic-surgery#:~:text=It%20truly%20is%20an%20incredible,were%20impacted%20by%20the%20pandemic.)

The implementation of robotic surgery at Tygerberg Hospital has been successful, with three gynaecolological surgeons already trained and performing cases since May 2022. (https://www.sun.ac.za/english/Lists/news/DispForm.aspx?ID=9237#:~:text=This%20minimally%20invasive%20procedure%2C%20which,every%20year%2C%20including%20cancer%20patients.)

The areas where the hospital has found benefit so far are in advanced endometriosis (with over 40 cases at the time of publication) and oncology, specifically endometrial cancers (with 16 cases thus far). Robotic surgery has proven especially advantageous in these complex procedures, offering improved precision and control for the surgeons.

One of the main advantages of robotic surgery is the reduced mental and physical fatigue experienced by surgeons. (Shugaba, A., Lambert, J.E., Bampouras, T.M. et al. Should All Minimal Access Surgery Be Robot-Assisted? A Systematic Review into the Musculoskeletal and Cognitive Demands of Laparoscopic and Robot-Assisted Laparoscopic Surgery. J Gastrointest Surg 26, 1520–1530 (2022). https://doi.org/10.1007/s11605-022-05319-8

The robotic systems allow for better ergonomics and provide more comfortable working positions compared to traditional laparoscopic or open surgeries. This can lead to improved mental function, reduced physical fatigue, improved surgical outcomes and decreased risk of errors or complications.

Additionally, robotic surgery has benefited patients with a high BMI (Body Mass Index). Traditional laparoscopic surgery can be technically challenging in patients with a high BMI due to limited visualization and manoeuvrability. The enhanced visualization, dexterity, and control offered by robotic systems can help overcome these challenges, allowing surgeons to perform procedures more effectively and safely in patients with higher BMIs.

Overall, the introduction of robotic surgery at both hospitals is a positive development that offers benefits to both surgeons and patients.

4. Summary

The following procedures in general gynaecology and gynaecologic oncology should be considered for MIS on the robotic platform where available:

  • Women treated for presumed early-stage endometrial cancer as follows: hysterectomy, BSO, pelvic with or without para-aortic lymphadenectomy or sentinel lymph node biopsy algorithm.
  • Women diagnosed with endometrial hyperplasia with atypia or endometrial carcinoma in situ as follows: hysterectomy, with sentinel lymph node biopsy algorithm.
  • Selected women with stage one cervical cancer as follows: trachelectomy or hysterectomy, with or without BSO, pelvic lymphadenectomy or sentinel lymph node biopsy algorithm.
  • Selected women with stage one ovarian cancer requiring completion surgery consisting of: BSO with or without hysterectomy, pelvic and/or paraaortic lymphadenectomy and omentectomy.
  • Endometriosis surgery for stage 3 and 4 diseases with appropriately trained surgeons
  • Sacrocolpopexy with mesh. In some of these women, subtotal hysterectomy will be indicated as well.

References

  1. Bush SH, Apte SM. Robotic-assisted surgery in gynecological oncology. Cancer Control. 2015; 22(3):307-13. doi:10.1177/107327481502200308
  2. Capozzi VA, Scarpelli E, Armano G, Monfardini L, Celardo A, Munno GM, et al. Update of robotic surgery in benign gynecological pathology: Systematic review. Medicina (Kaunas). 2022; 58(4) doi:10.3390/medicina58040552
  3. Nicklin J. The future of robotic-assisted laparoscopic gynaecologic surgery in Australia – a time and a place for everything. Aust N Z J Obstet Gynaecol. 2017; 57(5):493-8. doi:10.1111/ajo.12688
  4. Xie Y. Cost-effectiveness of robotic surgery in gynecologic oncology. Curr Opin Obstet Gynecol. 2015; 27(1):73-6. doi:10.1097/gco.0000000000000134
  5. Janda M, Gebski V, Davies LC, Forder P, Brand A, Hogg R, et al. Effect of total laparoscopic hysterectomy vs total abdominal hysterectomy on disease-free survival among women with stage 1 endometrial cancer: A randomized clinical trial. Jama. 2017; 317(12):1224-33. doi:10.1001/jama.2017.2068
  6. Rakha E, Wong SC, Soomro I, Chaudry Z, Sharma A, Deen S, et al. Clinical outcome of atypical endometrial hyperplasia diagnosed on an endometrial biopsy: Institutional experience and review of literature. Am J Surg Pathol. 2012; 36(11):1683-90. doi:10.1097/PAS.0b013e31825dd4ff
  7. Ramirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med. 2018; 379(20):1895-904. doi:10.1056/NEJMoa1806395
  8. Greggi S, Casella G, Scala F, Falcone F, Visconti S, Scaffa C. Surgical management of early cervical cancer: When is laparoscopic appropriate? Curr Oncol Rep. 2020; 22(1):7. doi:10.1007/s11912-020-0876-1
  9. Oliver JL, Kim JH. Robotic sacrocolpopexy – is it the treatment of choice for advanced apical pelvic organ prolapse? Curr Urol Rep. 2017; 18(9):66. doi:10.1007/s11934-017-0715-6
  10. Casarin J, Song C, Multinu F, Cappuccio S, Liu E, Butler KA, et al. Implementing robotic surgery for uterine cancer in the United States: Better outcomes without increased costs. Gynecol Oncol. 2020; 156(2):451-8. doi:10.1016/j.ygyno.2019.11.016
  11. Gomolin A, Gotlieb W, Lau S, Salvador S, Racovitan F, Abitbol J. Mandate to evaluate robotic surgery implementation: A 12-year retrospective analysis of the impact and future implications. J Robot Surg. 2022; 16(4):783-8. doi:10.1007/s11701-021-01327-z
  12. Chen SH, Li ZA, Huang R, Xue HQ. Robot-assisted versus conventional laparoscopic surgery for endometrial cancer staging: A meta-analysis. Taiwan J Obstet Gynecol. 2016; 55(4):488-94. doi:10.1016/j.tjog.2016.01.003
  13. Franasiak J, Ko EM, Kidd J, Secord AA, Bell M, Boggess JF, et al. Physical strain and urgent need for ergonomic training among gynecologic oncologists who perform minimally invasive surgery. Gynecol Oncol. 2012; 126(3):437-42. doi:10.1016/j.ygyno.2012.05.016
  14. Hotton J, Bogart E, Le Deley MC, Lambaudie E, Narducci F, Marchal F. Ergonomic assessment of the surgeon’s physical workload during robot-assisted versus standard laparoscopy in a French multicenter randomized trial (robogyn-1004 trial). Ann Surg Oncol. 2023; 30(2):916-23. doi:10.1245/s10434-022-12548-3
  15. Moss EL, Sarhanis P, Ind T, Smith M, Davies Q, Zecca M. Impact of obesity on surgeon ergonomics in robotic and straight-stick laparoscopic surgery. J Minim Invasive Gynecol. 2020; 27(5):1063-9. doi:10.1016/j.jmig.2019.07.009