Alan Moss|Kumanan Nalankilli
Completing the circle of informed consent for EMR versus surgery for nonmalignant large or complex colorectal polyps
Western Health|University of Melbourne|Western Health
process informed consent critical therapeutic relationship procedural physicians patients allows patients legally responsible care make informed decisions intended treatment procedure therefore outline risks benefits procedure also involve discussion alternative management options associated risks benefits studies explored characteristics adequacy informed consent process colonoscopy found patients often inadequately informed procedure australian study surveyed patients colonoscopy demonstrated measures patientperceived knowledge impending colonoscopy significantly lower would preferred patients1gett rm cooray ar gold et alevaluating informed consent colonoscopysurg laparosc endosc percutan tech 2014 24 345352crossref pubmed scopus 5 google scholar study united states evaluating colonoscopy consent process demonstrated significant variability patients understanding colonoscopy2kingmarshall ec mueller n dailey et al another test want patient caregiver understanding colonoscopy procedure patient educ couns epub 2015 nov 2google scholar study also confirmed strong association patients health literacy understanding colonoscopy procedure informed consent process2kingmarshall ec mueller n dailey et al another test want patient caregiver understanding colonoscopy procedure patient educ couns epub 2015 nov 2google scholar therapeutic procedures emr large advanced colorectal polyps complex routine colonoscopy carry significantly greater risks often involve discussion alternative treatments surgical resection sr therefore achieving satisfactory informed consent challenging standard diagnostic colonoscopy much difficulty likely encountered consenting colonoscopy emr context informed consent process must robust complete detailed picture procedural risks alternative options must clearly conveyed patient modern endoscopic innovations emr widened range indications therapeutic colonoscopy western world emr increasingly replacing surgery preferred initial strategy remove large complex colorectal polyps whose features suggestive malignancy increasing body evidence support efficacy safety emr largest emr studies date multicenter australian colonic emr group evaluated efficacy emr sessile colorectal polyps 20 mm greater size success rate 892 first session demonstrated3moss bourke mj williams sj et alendoscopic mucosal resection outcomes prediction submucosal cancer advanced colonic mucosal neoplasiagastroenterology 2011 140 19091918abstract full text full text pdf pubmed scopus 436 google scholar mortality related procedure observed followup study evaluating early late recurrence rates widefield emr advanced colonic mucosal neoplasia found early recurrence rate 4 months 16 late recurrence rate 16 months 44moss williams sj hourigan lf et allongterm adenoma recurrence following widefield endoscopic mucosal resection wfemr advanced colonic mucosal neoplasia infrequent results risk factors 1000 cases australian colonic emr ace studygut 2015 64 5765crossref pubmed scopus 324 google scholar ninetythree percent recurrences able removed endoscopically followup colonoscopy recurrent adenoma usually unifocal diminutive initial emr deemed successful contain submucosal invasion requiring surgery 98 patients adenoma free avoided surgery 16 months emr data form strong basis discussing efficacy emr informed consent process respect emr adverse events aes initial study 479 patients 13 perforation rate documented3moss bourke mj williams sj et alendoscopic mucosal resection outcomes prediction submucosal cancer advanced colonic mucosal neoplasiagastroenterology 2011 140 19091918abstract full text full text pdf pubmed scopus 436 google scholar however followup study significantly larger patient numbers 4 1095 patients 037 required surgery treat emrinduced perforations4moss williams sj hourigan lf et allongterm adenoma recurrence following widefield endoscopic mucosal resection wfemr advanced colonic mucosal neoplasia infrequent results risk factors 1000 cases australian colonic emr ace studygut 2015 64 5765crossref pubmed scopus 324 google scholar similarly large emr study united states rate emrinduced perforation 0365buchner guarnerargente c ginsberg gg outcomes emr defiant colorectal lesions directed endoscopy referral centergastrointest endosc 2012 76 255263abstract full text full text pdf pubmed scopus 190 google scholar rate postemr bleeding 7 2 large studies5buchner guarnerargente c ginsberg gg outcomes emr defiant colorectal lesions directed endoscopy referral centergastrointest endosc 2012 76 255263abstract full text full text pdf pubmed scopus 190 google scholar 6metz aj bourke mj moss et alfactors predict bleeding following endoscopic mucosal resection large colonic lesionsendoscopy 2011 43 506511crossref pubmed scopus 142 google scholar data form strong basis discussing risks emr informed consent process role surgery management colorectal cancer well established large observational studies evaluating surgical outcomes published mortality rates 54 74 colectomy reported birkmeyer et al7birkmeyer jd siewers ae finlayson ev et alhospital volume surgical mortality united statesn engl j med 2002 346 11281137crossref pubmed scopus 4096 google scholar analysis 300000 patients united states 5year period mcnicol et al8mcnicol l story da leslie k et alpostoperative complications mortality older patients noncardiac surgery three melbourne teaching hospitalsmed j aust 2007 186 447452pubmed google scholar reported 5 mortality rate day 30 colonic surgery patients 70 years older 28 incidence serious postoperative aes however studies involved heterogenous patient populations including elderly patients malignancy exclude patients severe systemic illness therefore data might helpful estimating risks sr informed consent process nonmalignant polyps likely overestimate risk many patients large complex polyps asymptomatic may lesions detected via bowel cancer screening programs large emr study showed 87 patients underwent emr classified american society anesthesiologists asa grade ii9ahlenstiel g hourigan lf brown g et alactual endoscopic versus predicted surgical mortality treatment advanced mucosal neoplasia colongastrointest endosc 2014 80 668676abstract full text full text pdf pubmed scopus 119 google scholar therefore difficult complete circle informed consent process accurate data regarding surgical risk resection large advanced colonic polyps without malignancy lacking particular gastroenterologist nonsurgeon proceduralists discussing emr patients difficult reliably inform patients surgical risk neither feasible practical refer every patient surgeons opinion especially suggestion malignancy attempt estimate risk comparing actual emr outcomes predicted surgical outcomes using wellvalidated models association coloproctology great britain ireland score colorectal physiologic operative severity score enumeration mortality morbidity recently published9ahlenstiel g hourigan lf brown g et alactual endoscopic versus predicted surgical mortality treatment advanced mucosal neoplasia colongastrointest endosc 2014 80 668676abstract full text full text pdf pubmed scopus 119 google scholar study showed actual 30day mortality emr 1050 patients 0 versus predicted surgical mortality cohort 33 p 0001 conferring significant theoretical advantage emr surgery9ahlenstiel g hourigan lf brown g et alactual endoscopic versus predicted surgical mortality treatment advanced mucosal neoplasia colongastrointest endosc 2014 80 668676abstract full text full text pdf pubmed scopus 119 google scholar however remains estimate furthermore study assessed mortality aes setting present study keswani et al10keswani rn law r ciolino jd et aladverse events surgery nonmalignant colon polyps common associated increased length stay costsgastrointest endosc 2016 84 296303google scholar titled adverse events surgery nonmalignant colon polyps common associated increased length stay costs timely provides data pertaining actual surgical outcomes cohort retrospective study united states assessed outcomes either surgery emr nonmalignant large complex polyps complex polyp defined polyp referring colonoscopist unable remove sr cohort comprised 359 patients 11year period 2003 2013 underwent sr complex polyps note nonmalignant complex colonic polyps included surgical cohort patients invasive carcinoma excluded endoscopic resection er cohort included 198 patients 3year period 20112013 however er cohort include patients found invasive colon adenocarcinoma time attempted emr histologic analysis emr specimens patients groups asa grades ii 71 sr cohort 82 er cohort primary outcomes measured 12month ae rate hospital costs patient charges length stay aes significantly delayed discharge initial hospital admission caused readmission within 12 months included comparative analyses 2 groups performed overlapping period 2011 2013 sr success rate 99 exceeded er success rate 84 sr cohort aes higher 18 vs 10 p 09 although reach statistical significance common surgical aes delayed discharge included prolonged ileus 2 sr patients wound infection 1 anastomotic leak 1 common reasons readmission infection 2 anastomotic leak 2 additional surgery postoperative aes required 3 sr patients within 12 months surgery 14 mortality 12 months compared zero mortality er sr cohort surgical risks significantly increased every 1point increase asa class odds ratio 250 p 03 body mass index odds ratio 106 p 002 surgical approach open vs laparoscopic lesion location right side vs left side colon median length stay significantly longer sr compared er 5 vs 0 days p 0001 median costs index hospitalization significantly higher sr cohort versus er cohort us15264 vs us2152 p 0001 similarly median patient charges also significantly higher sr vs er us52960 vs us14836 p 0001 furthermore aes occurred sr cohort median total hospital costs us25557 vs us14029 p 0001 patient charges us75302 vs us35362 p 0001 length stay 11 vs 5 days p 0001 increased substantially data quantify economic impact sr hospital costs patient charges hospital bed occupancy compared er financial considerations also likely influence patients decision making informed consent process well impact health budget health insurers therefore warrant discussion experience gastroenterologists performing emr patients prefer emr surgery suspicion malignancy prefer keep colons intact patients usually referred gastroenterologists surgeon colonoscopists emr service expectation proceeding emr attend consultation armed endoscopic photos sometimes histopathology results biopsies lesion question helpful confirming referring colonoscopists impression lesion suitable emr success rates emr high albeit lower surgery however patients feel compensated advantages emr avoidance abdominal wounds sedation rather general anesthesia daystay hospitalization maintaining normal bowel function anatomy fact emr preclude subsequent surgery required factors contribute patients decision making favor emr however keswani et als data showing lower ae rates emr compared surgery nature frequency aes specific surgical cohort final pieces puzzle required complete circle informed consent emr versus surgery nonmalignant large complex colorectal polyps far better position ensure patients informed consent colonoscopy emr truly fully informed authors disclosed financial relationships relevant publication adverse events surgery nonmalignant colon polyps common associated increased length stay costsgastrointestinal endoscopyvol 84issue 2previewendoscopic resection er safe effective treatment nonmalignant complex colorectal polyps complex polyps surgical resection sr remains prevalent despite limited outcomes data aimed evaluate sr outcomes complex polyps compare sr outcomes er fulltext pdf