Problemi non risolti in coloproctologia: emorroidectomia o emorroidopessi?

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1 Ospedale S. Maria dei Battuti U.O.C. Chirurgia Generale (Dir.: G. Munegato) Conegliano (TV) Problemi non risolti in coloproctologia: emorroidectomia o emorroidopessi? Dr. Michele Schiano di Visconte U.O.S. di Colonproctologia

2 Problemi non risolti in coloproctologia: emorroidectomia o emorroidopessi? Emorroidectomia vs Emorroidopessi Edward Thomas Campbell Milligan Milligan ETC, Morgan CN, Jones LE, Officer R Surgical anatomy of the anal canal, and the operative treatment of haemorrhoids. Lancet 1937; 233: Antonio Longo Longo A Treatment of Hemorrhoid Disease by Reduction of Mucosa and Hemorrhoid Prolapse with a Circular- Suturing Device: a New Procedure. Proceedings of the 6th World Congress of Endoscopic Surgery, pp Rome, Italy, June 3 6, 1998

3 Problemi non risolti in coloproctologia: emorroidectomia o emorroidopessi? Fisiopatologia della malattia emorroidaria Età, familiarità, stili di vita Aumento della pressione addominale (stipsi, gravidanza, ecc.) Anopessi Cedimento del tessuto connettivo di supporto PROLASSO Doppia PPH 03 Alterato ritorno venoso Emorroidectomia CONGESTIONE Fragilità dei plessi ( flogosi) SANGUINAMENTO BMJ 2008;336: Gastroenterology 2004;126:

4 Problemi non risolti in coloproctologia: emorroidectomia o emorroidopessi? Emorroidectomia: tecnica APERTA (Milligan-Morgan, 1937) excision-ligation open technique A partire dalla metà degli anni cinquanta diverse varianti tecniche sono state proposte al fine di ridurre il discomfort postoperatorio. Per lo stesso scopo, in anni più recenti, sono stati ideati dispositivi per la dissezione chirurgica sempre più sofisticati (Harmonic Scalpel TM, laser, Ligasure TM, ecc.). SOTTOMUCOSA (Parks, 1956) CHIUSA (Ferguson, 1959) DIATERMICA (Loder-Phillips, 1993) diathermy excision without ligation open tecnique

5 Problemi non risolti in coloproctologia: emorroidectomia o emorroidopessi? Emorroidopessi con stapler (PPH): tecnica Anche la tecnica dell emorroidopessi con stapler nasce dall esigenza di offrire al paziente un trattamento chirurgico meno doloroso. Tuttavia il meccanismo d azione su cui si basa (riduzione del prolasso muco-emorroidario) è radicalmente diverso rispetto all emorroidectomia (asportazione del prolasso muco-emorroidario). Corman ML et al. Stapled haemorrhoidopexy: a consensus position paper by an international working party indications, contraindications and technique. Colorectal Dis 2003;5:

6 Problemi non risolti in coloproctologia: emorroidectomia o emorroidopessi? Linee guida a confronto I grado II grado III grado IV grado Terapia medica Terapia medica Terapia ambulatoriale (legatura elastica) oppure Terapia chirurgica (emorroidectomia) Stapled hemorrhoidectopexy is a new alternative available for individuals with significant hemorrhoidal prolapse Terapia chirurgica (emorroidectomia) National UK audit Procedure for PPH is a safe and effective procedure for symptomatic haemorrhoids with good short-term outcomes. Long-term follow up is required perhaps through a compulsory national register Dis Colon Rectum 2005;48: Tech Coloproctol 2006;10: Colorectal Disease 2008;10:

7 NICE Recommendation 2007 Stapled haemorrhoidopexy, using a circular stapler specifically developed for haemorrhoidopexy, is recommended as an option for people in whom surgical intervention is considered appropriate for the treatment of prolapsed internal haemorrhoids.

8 Problemi non risolti in coloproctologia: emorroidectomia o emorroidopessi? Emorroidectomia vs Emorroidopessi: outcomes Dolore postoperatorio Complicanze acute (emorragia, ritenzione urinaria, secrezione anale persistente, trombosi emorroidaria esterna, ecc.) Degenza e ripresa dell attività lavorativa Costi Complicanze tardive (incontinenza fecale, stenosi, disturbi della defecazione, dolore cronico, ecc.) Recidiva (sanguinamento/prolasso)

9 Problemi non risolti in coloproctologia: emorroidectomia o emorroidopessi? Analisi della letteratura: outcomes Outcomes No. metanalisi Emorroidopessi Emorroidectomia NS Dolore postoperatorio 8 Emorragia postoperatoria (reintervento) 6 Ritenzione urinaria 7 Durata della degenza 8 Ripresa dell attività lavorativa 6 Secrezione anale/guarigione 7 Soddisfazione del paziente (QoL) 6 Costi 2 Stenosi 9 Incontinenza 9 Recidiva 8 = metanalisi favorevole

10 PPH short-term outcomes Ho Mehigan Rowsell Ganio Shalaby Boccasanta Pavlidis Ortiz Correa-Rovelo Hetzer Kairaluoma Palimento Year No. Pain Hospital Stay Normal Activity Cx s Better Same Not recorded

11 Valutazione del dolore postoperatorio in pt. sottoposti a Milligan & Morgan V6 A 5 4 S giorni Sielezneff Personale Senagore Sielezneff I et al: J.Chir. (Paris) Nov; 134(5-6): (71% pz severo) Rilevazione personale (54 Ferguson 54 Milligan-Morgan) A.G. Senagore et al. - DCR 2004; 47: (Ferguson)

12 Content of meta - analysis Meta-analysis for following outcomes: persistent urgency, persistent pain, skin tags, internal analsphincter damage as well as patient satisfaction was not performed due to methodological problems (in homogeneity of studies and types of measurements) Meta-analysis for following outcomes: 1. postoperative anal incontinence, 2. anal stenosis, 3. bleeding at stool, 4. recurrence of prolapsing hemorrhoids 5. incidence of re-prolapse related redo-surgery

13 Incontinenza Fecale Review: Comparison: Outcome: PPH_U PPH versus MM 01 Anal Incontinence Study PPH MM RR (random) Weight RR (random) or sub-category n/n n/n 95% CI % 95% CI Quality 01 Small studies Au-Yong 1/11 2/ [0.04, 3.82] D v.d.stadt 0/20 0/20 Not estimable D Subtotal (95% CI) [0.04, 3.82] Total events: 1 (PPH), 2 (MM) Test for heterogeneity: not applicable Test for overall effect: Z = 0.78 (P = 0.43) 02 large studies Racalbuto 0/50 3/ [0.01, 2.70] D Gravie 6/52 5/ [0.43, 4.05] D Subtotal (95% CI) [0.08, 5.26] Total events: 6 (PPH), 8 (MM) Test for heterogeneity: Chi² = 2.04, df = 1 (P = 0.15), I² = 50.9% Test for overall effect: Z = 0.40 (P = 0.69) Total (95% CI) [0.22, 2.36] Total events: 7 (PPH), 10 (MM) Test for heterogeneity: Chi² = 2.49, df = 2 (P = 0.29), I² = 19.6% Test for overall effect: Z = 0.53 (P = 0.59) Favours PPH Favours MM

14 Stenosi Anale Review: Comparison: Outcome: PPH_U PPH versus MM 03 Stenosis Study PPH MM RR (random) Weight RR (random) or sub-category n/n n/n 95% CI % 95% CI Quality 01 Small studies Au-Yong 2/9 2/ [0.16, 4.93] D v.d.stadt 0/20 2/ [0.01, 3.92] D Subtotal (95% CI) [0.14, 2.71] Total events: 2 (PPH), 4 (MM) Test for heterogeneity: Chi² = 0.78, df = 1 (P = 0.38), I² = 0% Test for overall effect: Z = 0.65 (P = 0.52) 02 large studies Racalbuto 0/50 0/50 Not estimable D Gravie 0/52 1/ [0.02, 8.76] D Subtotal (95% CI) [0.02, 8.76] Total events: 0 (PPH), 1 (MM) Test for heterogeneity: not applicable Test for overall effect: Z = 0.62 (P = 0.53) Total (95% CI) [0.15, 2.14] Total events: 2 (PPH), 5 (MM) Test for heterogeneity: Chi² = 0.86, df = 2 (P = 0.65), I² = 0% Test for overall effect: Z = 0.85 (P = 0.40) Favours PPH Favours MM

15 Sanguinamento post-operatorio Review: Comparison: Outcome: PPH_U PPH versus MM 07 Bleeding at stool Study PPH MM RR (random) Weight RR (random) or sub-category n/n n/n 95% CI % 95% CI Quality 01 small studies Au-Yong 5/11 4/ [0.39, 2.71] D Smyth 5/20 4/ [0.32, 3.12] D v.d.stadt 5/20 6/ [0.30, 2.29] D Subtotal (95% CI) [0.52, 1.72] Total events: 15 (PPH), 14 (MM) Test for heterogeneity: Chi² = 0.09, df = 2 (P = 0.95), I² = 0% Test for overall effect: Z = 0.18 (P = 0.86) 02 large studies Racalbuto 0/50 8/ [0.00, 0.99] D Subtotal (95% CI) [0.00, 0.99] Total events: 0 (PPH), 8 (MM) Test for heterogeneity: not applicable Test for overall effect: Z = 1.97 (P = 0.05) Favours PPH Favours MM

16 Conclusion of the Meta-analysis in terms of anal incontinence, anal stenosis and bleeding at stool Meta-analysis showed less numeric incidence of the anal incontinence as well as the anal stenosis in favor of stapler hememorrhoidopexy compared to MM but without statistical significance. Meta-analysis for bleeding at stool showed numeric similar incidence rate in the subgroup of 3 small studies without statistical significance. The trial Racalbuto et al showed statistically significant less incidence of symptom - bleeding at stool- in favor of PPH.

17 Recidiva del prolasso/malattia emorroidaria

18 Reinterventi Review: Comparison: Outcome: PPH_U PPH versus MM 12 Re-surgery due to prolapse Study PPH MM RR (random) Weight RR (random) or sub-category n/n n/n 95% CI % 95% CI Quality 01 small studies Au-Yong 1/11 0/ [0.11, 54.87] D v.d.stadt 4/20 0/ [0.52, ] D Subtotal (95% CI) [0.61, 40.62] Total events: 5 (PPH), 0 (MM) Test for heterogeneity: Chi² = 0.37, df = 1 (P = 0.54), I² = 0% Test for overall effect: Z = 1.50 (P = 0.13) 02 large studies Racalbuto 1/50 0/ [0.13, 71.92] D Subtotal (95% CI) [0.13, 71.92] Total events: 1 (PPH), 0 (MM) Test for heterogeneity: not applicable Test for overall effect: Z = 0.68 (P = 0.50) Total (95% CI) [0.74, 24.60] Total events: 6 (PPH), 0 (MM) Test for heterogeneity: Chi² = 0.44, df = 2 (P = 0.80), I² = 0% Test for overall effect: Z = 1.63 (P = 0.10) Favours PPH Favours MM

19 Conclusion of the Meta-analysis II In terms of recurrence of prolapsing hemorrhoids, statistical significant borderline superiority (p=0.05, CI- 95%) in favor of MM was noted. In terms of the incidence of the re-prolapse related redosurgery, the meta-analysis showed no statistically significant difference between either type of treatment.

20 Conclusion of the Systematic review (Metaanalysis) The superiority of Milligan-Morgan hemorrhoidectomy compared to PPH regarding long-term outcomes such as incidence of impaired anal continence anal stenosis, bleeding at stool as well as the definitive surgical resolution of hemorrhoidal symptoms, (redo surgery of prolapsing hemorrhoids) could not be confirmed. The superiority of MM compared to PPH could be confirmed regarding incidence of recurrence of prolapsing hemorrhoids.

21 Problemi non risolti in coloproctologia: emorroidectomia o emorroidopessi? Le ragioni degli insuccessi 1. Complicanza (immediata o tardiva) propriamente detta 2. Inadeguatezza dell indicazione all impiego dell una o dell altra metodica 3. Inadeguatezza dell esecuzione tecnica dell una o dell altra metodica

22 Problemi non risolti in coloproctologia: emorroidectomia o emorroidopessi? Emorroidopessi: complicanze life-threatening Dis Colon Rectum 2003;46:116-7 Dis Colon Rectum 2002;45: The following represents the consensus of the working party as minimal requirements: experience with anorectal surgery and an understanding of anorectal anatomy is a requisite; experience with circular stapling devices is essential; the surgeon must attend a formal course. Colorectal Dis 2003;5:

23 Problemi non risolti in coloproctologia: emorroidectomia o emorroidopessi? Emorroidectomia: complicanze life-threatening Dis Colon Rectum 1999;42: Dis Colon Rectum 1994;37:185 9 Necrotizing fasciitis and streptococcal toxic shock syndrome after hemorrhoidectomy Cozar Ibañez A, del Olmo Escribano M, Jiménez Armenteros F, Moreno Montesinos JM Rev Esp Enferm Dig 2003;95:68-70 Sepsis after conservative or operative treatment is uncommon, but it may be catastrophic Both established and newer techniques should be taught and mastered diligently, and unnecessary treatment avoided. Br J Surg 2003;90:

24 CONCLUSIONI Meno dolore Veloce ripresa attività lavorativa Eseguibile in One Day Surgery Minor incidenza di complicanze a lungo termine rispetto MM Attualmente > recidiva del prolasso nel lungo termine ma Per entrambe le tecniche è comunque necessaria una adeguata formazione ed esperienza.