Hassan Morsi MD MRCOG Consultant Obstetrician & Gynaecologist

1. 'Urinary Tract Injuries in Gynaecological Laparoscopic Surgery; What is the role of intra operative cystoscopy ?‘ Hassan Morsi MD MRCOG Consultant Obstetrician & Gynaecologist Special Interest: Minimal Access Surgery Dudley Hospitals NHS Foundation Trust Honorary Senior Clinical Lecturer, University of Birmingham United Kingdom

2. Sir Thomas Spencer Wells 1882 President of the RCS First surgeon to successfully perform an ovarian cystectomy Would there be any experienced gynaecological surgeon who has not injured the urinary tract at some time during pelvic surgery in his career? I have always been obsessed with reducing ureteral injuries. Most are not identified or even suspected without cystoscopy, even if the surgeon is visually able to identify the ureters. Normal peristalsis may occur in a damaged ureter. “I do not see any mode of certainty providing against the mischance of dividing one or both ureters. I fear that, with all possible care, it is an accident which may occasionally be unavoidable”. Harry Reich 3, 2003, 32-40 Laparoscopic Hysterectomy in current gynaecological practice Reviews in Gynaecological Practice

3. Triad of major laparoscopic complications Chronic infection Strictures Calculi Urinary incontinence / fistula Loss of kidney Disability High risk of litigation Referral to urology; loss of contact

4. Are ureter injuries increasing over the past decades ? • Parpala-Spårman T et al; 2008, Scand J Urol Nephrol, reviewed 20 years; ureteric injuries with laparoscopic surgery • Makinen 2001; Finnish study; 10110 hysterectomies, RR 7.2 ureteral injuries with laparoscopic versus abdominal hysterectomy • Medical Negligence claims over 30 years: 70/year 1974, 5965/year 2003 • Cost over 30 years: 1 million to 446 million £ • “Culture of compensation”, ‘for every accident someone is at fault, every injury someone is to blame, for every accident someone has to pay’.

5. Risk factors for urinary tract injury • Harkki-Siren 1998; Bleeding (57%) • Enlarged uterus (24%), endometriosis, adhesions, obesity • ‘Difficulty during surgery’; bladder injury in 53% LH, 37% of TAH • 40% - 50% of all ureter injuries; no identifiable predisposing factors; ‘routine surgery’ • Harkki-Siren 1999; all gynae laparoscopies; urinary injury 2.5/1000. • Total major complications reduced (4.9% to 2.3% over 3 years) • Ureteral complications remained static at 1% of laparoscopic hysterectomies. • Inherent nature / intrinsic nature ? ....apologetic/guilty surgeon • Learning curve ? • Surgical expertise; lower in university hospitals (0.9% vs 2.6%)

6. Laparoscopic Surgery more dangerous ? Injury was in most cases located in the lower ureter (89%). Diagnosis; usually delayed (in 79%), with a median time to diagnosis of 6 days. Urinary tract injury in Gynaecological laparoscopic surgery; 0.3% - 4% (LAVH 0.49%, TLH 4%)

7. Why ? The risk of injuries especially to the ureter, is increased with the laparoscopic approach.

8. lack of tactile sensations; • decreased mobility for manipulation; • reduced visual field, depth perception & panoramic view • reluctance of the gynecologist to gain entry into the retroperitoneal space; • suboptimal knowledge of pelvic anatomy; • reliance on hemostatic energy devices and stapling tools (not commonly used in open surgery); Baggish 2010 – 67% of ureteral injuries due to stapling, harmonic, tissue sealing devices

9. Urinary Tract injury Ureter and bladder are always anatomically close to major vasculature that is cut in major gynaecologic surgery Urinary tract injury in gynaecologic surgery commonly ends in litigation Medical negligence or unavoidable complication ?

10. Urinary tract injury, Gynaecological surgery and litigation • Gynaecologic surgery; causes up to 75% of iatrogenic injury to the ureter • The risk of litigation with Urinary tract injury is increased 70 – 90 x • 18% of litigation cases were recognised intraoperatively • Selzmann ;1996; J Urol, intraoperative detection rates as low as 11% Gilmour; 2005, Obstet Gynecol

11. Urinary tract injury at hysterectomy; universal cystoscopy in 2 prospective studies Gilmour 1999; 11.5% of ureteral injuries and 51.6% of bladder injuries detected intraoperatively without cystoscopy Ibeanu; 2009, Obstet Gynecol; 75% of urinary tract injury were unsuspected prior to cystoscopy Baggish; 2010, Journal Gyneco Surgery; over 24 years, 75 cases of urinary tract injury in gynecologic laparoscopy cases ; only 27% diagnosed intraoperatively, 50% in the late postoperative period Dwyer; 2010, Int Urogynecol J

12. Debate; Routine or Selective CystoscopyIn reality Urinary tract injury is fairly rare, so routine cystoscopy is not common Baggish 2010; “2 patients had kidney loss…… There is no better case example for the proponents of timely diagnosis (liberal use of cystoscopy) and timely treatment than this sort of catastrophe”

13. Urinary tract injury; negligent or an unavoidable complication? • Negligence: failure to act as a reasonably well qualified doctor would have acted under similar circumstances • Not Negligent: body of fellow practitioners would have acted in the same way in the same situation then not negligent • “Reasonable clinical practice”....variations in clinical practice....Clinical Practice guidelines based on expert opinion, clinical research (NICE, RCOG, NHMRC)....will provide answers in court

14. Expert opinion on deciding negligence: • 4 questions: • Operation performed to adequate standard • Urinary tract injury; is it a recognised complication even with careful technique • When should it be detected; intraoperatively or was the delay reasonable (bladder injuries more likely to be recognized than ureteral injuries without cystoscopy). Most injuries are still diagnosed postoperatively (only 1 in 3 bladder injuries, 1 in 10 ureter injuries are diagnosed intraoperatively without cystoscopy) • Would the outcome be different if detected intraoperatively (at present most gynaecologists do not perform cystoscopy even in difficult surgery) therefore not negligent as not widely accepted practice but could be seen as an unavoidable complication Dwyer; 2010, Int Urogynecol J

15. Should Cystoscopy be routine ? • ACOG; 1997, at the conclusion of any pelvic procedure both ureter & bladder should be inspected to confirm their integrity • ACOG; 2007, cystoscopy to rule out cystotomy and intravesical or intraurethral suture or mesh and to check bilateral ureteral patency during or after certain procedures……those procedures with relatively high risk of these complications (1-2%) may benefit from cystoscopy. • Linda Brubaker 2009 Obstet Gynaecol; hysterectomy-associated urinary tract injury is a preventable morbidity; more palatable to incorporate cystoscopy instead of suffering medicolegal action

16. High Quality medical practice • Prevention of injury • Early recognition • If we assume it is unavoidable in some cases, then early recognition becomes an obvious choice especially with increased emphasis on patient safety • Good data supports routine cystoscopy following major laparoscopic surgery (Ko 2008, Vakili 2005, Gustilo-Ashby 2006)

17. Vakili 2005; prospective, multicentre trial, 479 patients, all hysterectomies had routine cystoscopy • 100% detection rate ureteral injury • 94% detection of bladder injury • Negative predictive value; 99.8% • One injury missed, presented with VVF; tissue ischaemia/necrosis (Fasolino 2002; 2 VVF after LH despite normal cystoscopy • Thermal injuries to ureter; later onset

18. Conclusions; • Iatrogenic ureteral injuries have increased markedly during the past two decades. • Gynaecological laparoscopic procedures account for more than half of the injuries, and the most common location is the lower ureter. • To improve the management of ureteral injury there must be a high index of suspicion, especially in laparoscopic operations. • Universal cystoscopy with indigocarmine dye increases the detection rates, avoids diagnostic delay

19. To help you decide ? “Never Events” Would you leave out a swab or instrument count ? “Time out” is a risk management requirement. It is ultimately a surgeon’s individual decision – remember your patient’s safety depends on your decision Selective cystoscopy = low % of patients will leave theatre with an untreated lower urinary tract injury

20. Lawyers and patients will be increasingly asking: “should or could the urinary tract injury have been detected intraoperatively to avoid further complications and delayed corrective surgery ?”

21. Thank You