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Indian Journal of Surgical Oncology logoLink to Indian Journal of Surgical Oncology
letter
. 2020 May 23;11(4):613–614. doi: 10.1007/s13193-020-01093-8

Robotic Surgery-Safety and Effectiveness, in Comparison with Traditional Surgery, Present Context and Recent FDA Safety Warning

Kiran Kumar Boyina 1,, Saubhik Dasukil 2
PMCID: PMC7714869  PMID: 33299279

Introduction

Recent developments in robotic surgery are being spread to almost all the specialities of medicine. Surgical specialities like urology, cardiology and gynaecology are using robots with great success and as over as 65% of radical prostatectomies are done robotically in the US.3. Robotic surgeries come with inherent benefits; this technology is being shown as safe and effective compared with traditional surgical approaches [1,2]. The authors want to reinforce the fact that the long-term survival benefits to the patients in comparison with traditional surgery and robotic surgery are not established until date [3].

Evolution of Robotic Surgery

Puma 560 (1985) was the first robotic system used in neurosurgery to perform biopsy [4]. da Vinci Surgical robotic system (Intuitive Surgical Inc., Sunnyvale, CA, USA) is the widely accepted robotic system all over the world with FDA approval. By the end of 2017, there were a total number of 8,77,000 surgical procedures (approximately) performed by the da Vinci robotic surgical system with the help of 4409 surgical systems installed worldwide, compared with 7,53,000 in 2016 and 6,52,000 procedures done in 2015, respectively. [5] Many other robotic systems like Zeus surgical system and automated endoscopic system for optimal positional (AESOP) are also being used [4].

Purported advantages of robotic surgery are as follows:

S.no
1 Enhanced visualization of the field in three-dimensional high definition
2 Elimination of physiologic tremors
3 Multi-articulated instruments can be used
4 Fatigue reduction
5 Enhanced ergonomics
6 Possibility of telesurgery
7 Resident training
8 Reduced pain
9 Less blood loss
10 Minimal scarring
11 Low infection rate
12 Short recovery time
13 Surgical precision

Limitations of robotic surgery are as follows:

  1. Cost

  2. Appropriate training for the domain-specific robotically assisted surgeries

  3. Operating time

  4. Oncologic surgical outcome and their long-term survival benefits not established

FDA warning

In February 2019, FDA has issued a warning intended for patients and health care providers that the use of robotically assisted surgeries/minimally invasive surgeries and their long-term survival benefits to the patients, when compared with traditional surgeries, has not been established until date [2]. Hence, the FDA warns the patients and doctors to be aware of the lack of evidence regarding safety and effectiveness of the robotically assisted surgeries and it reinstates that marketing authorization has not been granted for the same. FDA also recommends the healthcare providers and patients to discuss the potential risk benefits and alternative surgical options to finally make a patient-informed treatment decision while dealing with surgeries involving robot-assisted or minimally invasive procedures.

Recent evidence from a phase III multicentre randomised LACC (laparoscopic/robotic-assisted approach to cervical cancer) trail done to evaluate the disease-free survival state in patients after 4.5 years of post-radical hysterectomy procedure showed that minimally invasive or robotic-assisted radical hysterectomy is associated with a higher rate of recurrence than with traditional open approach [6].

Conclusion

In summary, the term robotic surgery is a misnomer, as the procedures done by the robots are actually done by a surgeon behind an operating console, and hence, the terminology that should be used ideally is robotic-assisted surgery. In conclusion, robotic surgery is here to stay and the technology will continue to evolve. In the near future, robotic surgeries might take the centre stage and become the mainstream in all the medical specialities, but as of now, there is no formidable evidence to prove the safety, effectiveness and long-term survival benefits of robotically assisted surgeries in comparison with traditional surgeries.

Footnotes

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Contributor Information

Kiran Kumar Boyina, Email: kirankumar99200059@gmail.com.

Saubhik Dasukil, Email: souvikdasukil@gmail.com.

References

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