evidence med, robotic sx, urosurgery .pptx

Usefulness of robots in medicine.
Pro's and cons of using robots in general surgery, gynecology, laproscopy

1. Theory Questions Dr. Arulmozhi R amarajan PG Forum 30-09-2018

2. Question 1 1 . a) What is evidence based medicine?      b) Enumerate the types of clinical studies.      c) What is hierarchy of evidence in medical literature? 2+4+4

3. What is evidence based medicine? Evidence-based medicine is the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients . (Sacket et al. BMJ 1996) Evidence alone is never enough to make a clinical decision Decisions & Recommendations should be guided by a hierarchy of strength of evidence.

4. Types of clinical studies

5. Case series or Case reports C ollections of reports on the presentation / treatment of patients or a report on a single patient. They are just reports and there are no control groups No statistical validity

6. Case Control studies S tudies in which patients who already have a specific condition are compared with people who do not have the condition. Based on medical records and patient recall for data collection. Less reliable than RCTs and Cohort studies because showing a statistical relationship does not mean than one factor necessarily caused the other. 

7. Cohort Studies Identify a group of patients who are already taking a particular treatment or have an exposure , follow them forward over time, and then compare their outcomes with a similar group that has not been affected by the treatment or exposure being studied. Observational studies Not reliable as RCTs

8. Randomized Controlled Trials A study in which people are allocated at random (by chance alone) to receive one of several clinical interventions. One of these interventions is the standard of comparison or control . The control may be a standard practice, a placebo ("sugar pill"), or no intervention at all . Disadvantages Expensive in terms of time and money Volunteer biases: the population that participates may not be representative of the whole Does not reveal causation Advantages Good randomization will “wash out” any population bias Easier to blind/mask than observational studies

9. Systematic Review It is a type of literature review that collects and critically analyzes multiple research studies or papers . Eg . Cochrane Review Advantages Less costly to review prior studies than to create a new study Less time required than conducting a new study Results can be generalized and extrapolated into the general population more broadly than individual studies.

10. Meta analysis A method for systematically combining pertinent qualitative and quantitative study data from several selected studies to develop a single conclusion that has greater statistical power . This conclusion is statistically stronger than the analysis of any single study, due to increased numbers of subjects, greater diversity among subjects, or accumulated effects and results.

11. Evidence -based medicine (EBM), is about finding evidence and using that evidence to make clinical decisions. A cornerstone of EBM is the hierarchical system of classifying evidence . This hierarchy is known as the levels of evidence . Levels of Evidence

12. Levels of Evidence A ranking system used to describe the strength of the results measured in a Scientific study The design of the study – Case Report / Double blind trial T he endpoints measured (such as survival / quality of life) affect the strength of the evidence

13. Grades of Recommendation A Directly based on Level I evidence B Directly based on Level II evidence or extrapolated recommendations from Level I evidence C Directly based on Level III evidence or extrapolated recommendations from Level I or II evidence D Directly based on Level IV evidence or extrapolated recommendations from Level I, II, or III evidence

14. Practice Guideline A statement produced by a panel of experts that outlines current best practice to inform health care professionals and patients in making clinical decisions. The statement is produced after an extensive review of the literature and is typically created by professional associations, government agencies, and / or public or private organizations. Eg : NICE Guidelines

15. 2. a ) Prophylactic salpingectomy       b ) Robotic surgery in gynecology 5+5 Question 2

16. Surgical removal of the normal Fallopian tubes to prevent ovarian cancer It is suggested that this approach would yield a 20-40 % population risk reduction for ovarian cancer over the next 20 years. Prophylactic salpingectomy – what is it? 5 marks McAlpine JN, et al. Opportunistic salpingectomy: uptake, risks, and complications of a regional initiative for ovarian cancer prevention. Ovarian Cancer Research Program of British Columbia. Am J Obstet Gynecol 2014;210:471.e1–471.e11.

17. At pelvic surgery for benign disease of the uterus or ovaries In peri -menopausal women with a genetic predisposition for ovarian cancer When tubal ligation is desired for contraception Prophylactic salpingectomy – when is it done? ACOG Committee Opinion, January 2015 (Reaffirmed 2017 )

18. Should remove the tube from its fimbriated end and up to the uterotubal junction; the interstitial portions of the tubes do not need to be removed. Any fimbrial attachments on the ovary should be cauterized or removed. Care should be taken not to interrupt blood supply to the ovary. The HPE should include representative sections of the fallopian tube, any suspicious lesions, and an entire sectioning of the fimbriae. Prophylactic salpingectomy – how is it done?

19. Why? Because in these women, lesions have been found in the fallopian tubes that closely resemble ovarian high-grade serous carcinomas or serous tubal intraepithelial carcinomas. These lesions are thought to be the primary source of ovarian carcinoma that secondarily involves the ovary. Genetic studies show that these tubal lesions express a common  TP53 mutation , as do high-grade serous and endometrioid cancers. Prophylactic salpingectomy – for whom? W omen with a genetic predisposition for ovarian cancer

20. Gene expression of high-grade serous carcinomas is more closely related to the fallopian tube morphology than the ovarian surface epithelium. High-grade serous carcinomas express a müllerian marker ( PAX8 ) but not a mesothelial marker ( calretinin ). T hose at population risk undergoing routine pelvic surgery are also offered prophylactic salpingectomy . Prophylactic salpingectomy – for whom? Women with NO genetic predisposition for ovarian cancer

21. “Salpingectomy at the time of hysterectomy or as a means of tubal sterilization appears to be safe, without an increase in complications, such as the need for blood transfusions and readmissions, compared with hysterectomy alone or tubal ligation. Additionally , ovarian function does not appear to be affected by salpingectomy at the time of hysterectomy based on surrogate serum markers or response to in vitro fertilization.” Findley AD, et al. Short-term effects of salpingectomy during laparoscopic hysterectomy on ovarian reserve: a pilot randomized controlled trial. Fertil Steril 2013;100:1704–8.  Morelli M, et al. Prophylactic salpingectomy in premenopausal low-risk women for ovarian cancer: primum non nocere . Gynecol Oncol 2013;129:448–51.  Almog B, et al. Effects of salpingectomy on ovarian response in controlled ovarian hyperstimulation for in vitro fertilization: a reappraisal. Fertil Steril 2011;95:2474–6.  Prophylactic salpingectomy – how safe is it?

22. What is Robotic surgery? How does it compare with conventional and laparoscopic surgeries? What are the indications for robotic surgery in Gynecology? What are the pros and cons of robotic surgery in Gynecology? What does evidence say? Robotic surgery in Gynecology 5 marks

23. FDA approved Da Vinci Surgical System in 2005 for gynecological surgery.  Currently, hysterectomy , sacro - colpopexy , myomectomy, adnexal surgery, and lymphadenectomy are being performed. G ynecologic procedures of short duration and low complexity are unlikely to benefit from robotic-assisted surgery.  No advantage, possible disadvantage. Current status of robotic surgery in Gynecology

24. A console where the surgeon sits, views the screen, and controls the robotic instruments and camera via finger graspers and foot pedals; A robotic cart with three or four interactive arms that hold instruments through trocars attached to the patient; A three D camera and vision system; and W risted instruments with computer interfaces that translate the mechanical movements of the surgeon’s hands into computer algorithms that direct the instruments’ movements within the patient . C omponents of the current Robotic surgical system

25. Three-dimensional imaging with improved depth perception. The surgeon has autonomous control of the camera and instruments. T he robotic arm, with its wristed joint and six degrees of freedom, allows for greater dexterity than unassisted surgery and decreases normal hand tremors . Useful in complex endometriosis surgery, tubal recanalization. Less fatigue and stress for the surgeon. Advantages of robotic surgery

26. Longer operative time, higher costs No differences in short term morbidity I ncreased postoperative pneumonia? Higher incidence of vaginal cuff dehiscence likely with robotic-assisted hysterectomy? Disadvantages

27. The adoption of robotic technology for gynecologic surgery is not supported by high-quality patient outcomes, safety, or cost data.  Four RCTs compared robot-assisted surgery for benign gynecologic disease with laparoscopy, and none showed any benefit from using the robotic approach  What does evidence say? Sarlos D, et al. Robotic compared with conventional laparoscopic hysterectomy: a randomized controlled trial. Obstet Gynecol 2012 Paraiso MF, Ridgeway B, Park AJ, Jelovsek JE, Barber MD, Falcone T, et al. A randomized trial comparing conventional and robotically assisted total laparoscopic hysterectomy. Am J Obstet Gynecol 2013 Anger JT, et al. Robotic compared with laparoscopic sacrocolpopexy : a randomized controlled trial. Obstet Gynecol 2014

28. Reporting of adverse events is currently voluntary and unstandardized, and the true rate of complications is not known Overall, the current literature shows conflicting evidence and is of poor quality.  ACOG Committee opinion March 2015 (Reaffirmed 2017 ) Continued …

29. Benign hysterectomy: the College continues to recommend vaginal hysterectomy as the approach of choice for benign disease whenever feasible Myomectomy: the current literature is insufficient to comment on post-procedure conception rates or pregnancy outcomes. S acro-colpopexy : Robot-assistance is believed to facilitate this technically difficult procedure and allow more surgeons to offer a minimally invasive approach. G ynecologic procedures of short duration and low complexity are unlikely to benefit from robotic-assisted surgery. Gynec oncology: more studies are required to identify patients who would benefit from the robotic approach. ACOG Committee opinion March 2015 (Reaffirmed 2017 )

30. a ) Indications of uterine artery embolization  b ) Procedure and post-procedure care of a patient          after uterine artery embolization 4+6 Question 3

31. Obstetric Post partum hemorrhage Placenta previa Adherent placenta Cesarean Scar Pregnancy Gynecological Symptomatic fibroids AV malformation in the uterus causing AUB Indications: UAE has been tried for controlling acute and chronic genital bleeding in a wide variety of obstetric and gynecologic disorders.  Contraindications : Pregnancy , recent pelvic infection, incidental fibroids 4 marks

32. Counseling – what it is, length of stay in hospital, cost, expected outcomes, recovery time, complications including post embolization syndrome, extrusion of sub-mucous fibroid, non-target embolization, amenorrhea), alternatives to UAE Communication with the interventional radiologist Written consent 3+3 marks Pre-procedure

33. Correct diagnosis - MRI is more sensitive than US in detection of adenomyosis , identification of which may have an effect on outcome. Pregnancy & pelvic infection to be excluded; IUCD to be removed. Prophylactic antibiotics as per policy. Prophylactic Heparin if at increased risk of thromboembolic disease. Pre-treatment GnRH – optional. Pre treatment assessment: MRI is more sensitive than ultrasound

34. A dedicated C-arm machine and pulsed fluoroscopy facility. Experienced interventional radiologist and senior radiographer Pre-procedure analgesic. IV access, parenteral conscious sedation. Pre-procedure voiding. Catheter ideally avoided. NIBP monitoring, emergency medicines. Total procedure time about 60 to 90 minutes. The procedure

35. Right sided or bilateral femoral arterial access 4 or 5 French catheter is introduced under fluoroscopic guidance into the anterior division of the internal iliac and then the uterine artery The embolizing agent is injected under fluoroscopic guidance. The opposite uterine artery is also embolized Catheter is removed, hemostasis obtained manually or with a vascular closure device

36. Analgesic / anti-inflammatory medication / IV narcotics via pump Monitoring for complications: Immediate complications - groin hematoma, arterial thrombosis, dissection Early complications - post-embolization syndrome with pain, fever, nausea and malaise. Later complications - ovarian artery embolization leading to permanent amenorrhea, offensive vaginal discharge & urine infection. Fibroid expulsion and impaction may occur. Assess fibroid status after 3 months / 6 months Post-procedure care – Gynecologist / Radiologist / both

37. EMMY REST

38. EMMY Embolization versus Hysterectomy Randomized trial of Embolization versus Surgical Treatment for fibroids REST