Emorroidectomia e Nuove Tecnologie. A. Amato Struttura S. di Colonproctologia Ospedale di Sanremo

Transcription

1 Emorroidectomia e Nuove Tecnologie A. Amato Struttura S. di Colonproctologia Ospedale di Sanremo

2 Incidence and Complications of Operative Therapy Retrospective review Bleday R et al. Dis Colon Rectum 1992; 35: pts Conservative treatment 45.2% Injection/Infrared 0.7% Rubber Band Ligation 44.8% Surgery 9.3%

3 Hemorrhoidectomy Scissors Open Closed Monopolar diathermy Bipolar device Laser Harmonic Scalpel Ligasure

4 Open vs. Closed Hemorrhoidectomy You SY et al. Dis Colon Rectum 2005; 48: Closed Open Grade III / IV 29/11 33 / 7 Operating Time 25.2 min 16.5 min p<0.01 P.o. Pain p<0.05 Analgesic Consumption p<0.01 Hospital Stay (days) Healed Wound (3 weeks) 75% 18% p<0.001 Painful skin tags 5 % 20 % P.o. bleeding 0 % 2.5 % Wound dehiscence 7.5 %

5 Scissor Dissection vs. Diathermy Excision 1. Seow-Choen F et al. Dis Colon Rectum 1992; 35: Andrews BT et al. Dis Colon Rectum 1993; 36: (49 pts) 2 (20 pts) Operating time 20 vs 10 (p<0.05) I.O. Bleeding > > P.O. Pain P.O. Analgesia only for oral analgesics (p<0.02) P.O. defecation Hospital Stay Complications

6 Ligasure Combination of pressure and electrical energy Coagulation of vessels up to 7 mm Minimal thermal spread Limited tissue charring

7 Ligasure vs. Conventional Diathermy 1. Franklin EJ et al. Dis Colon Rectum 2003; 46: Palazzo FF et al. Br J Surg 2002; 89: Jayne DG et al. Br J Surg 2002; 89: Wang JY et al. World J Surg 2006; 30(3): Bessa SS Dis Colon Rectum 2008; 51: Operative time < L < L < L < L < L P.O. Pain < L < L < L P.O. Analgesia <L < L < L I.O. Blood Loss < L < L < L < L Day Surgery > L > L P.O. Complications Wound healing < L

8 Ligasure & Anal Stenosis Wang (2006) 2,4 % (1 / 42) Ramcharan (2005) 4 % (1 / 25) Gravante (2006) 2 % (4 / 203)

9 Ligasure vs. Conventional Hemorrhoidectomy Meta-analysis on short term outcomes Tan EK et al. Arch Surg 2007 Operative time p = 0.01 I.O. Blood loss p < 0.01 P.O. Pain (D1) p < 0.01 Hospital Stay Return to work P.O. Morbidity LH CH

10 Ligasure vs. Conventional Hemorrhoidectomy Long-term follow up Peters CJ et al. - Colorectal Disease Follow up: 36 months (30 pts.) Recurrent bleeding Fecal incontinence Resting anal pressure Maximal squeeze pressure EAS thickness LH IAS thickness p = 0.05 CH

11 Harmonic Scalpel High-frequency ultrasonic energy (55,000 Hz) Relatively low temperature (80 ) Minimal thermal spread (< 1.5 mm) Limited lateral thermal injury

12 Harmonic Scalpel vs. Electrocautery Hemorrhoidectomy Armstrong DN et al. Dis Colon Rectum 2001; 44: HS EC Patients P.O. Pain (D1,2,7,14,28) p<0.05 Analgesic Consumption (D1,2,7) p<0.01 P.O. Morbidity Tan JJ, Seow-Choen F Dis Colon Rectum 2001; 44: Patients P.O. Pain (D1,2,3,4,5,6) Analgesic Requirements P.O. Morbidity

13 Harmonic Scalpel vs. Milligan Morgan Ramadan E et al. Tech Coloproctol 2002; 6: HS MM Patients Duration of Surgery p<0.001 P.O. Hospitalization p<0.001 P.O. Pain (D1,7,14) p<0.001 Analgesic Consumption P.O. Morbidity

14 Ligasure vs. Harmonic Scalpel Hemorrhoidectomy Kwok et al. Dis Colon Rectum 2005; 48: LH HSH Patients Operative time p < I.O. Blood loss p = P.O. Pain p < Hospital Stay P.O. Morbidity

15 Harmonic Scalpel Hemorrhoidectomy Bipolar Scissors Hemorrhoidectomy Scissors Excision Chung CC et al. Dis Colon Rectum 2002; 45: MMH BSH HSH Patients Operative time (min) I.O. Blood loss (ml) p = Pain Score (D1 D7) 4.0 4,5 2,8 p = 0.04 Hospital Stay (days) 3.8 3,6 3,1 Return to work P.O. Morbidity

16 HeLP Hemorrhoid Laser Procedure Dearterializzazione emorroidaria Localizzazione doppler guidata Fotocoagulazione mediante energia laser focalizzata Tecnica sutureless

17 HeLP Hemorrhoid Laser Procedure Manipolo laser Doppler ad alta frequenza (20 MHz) Anoscopio dedicato Non richiede anestesia Learning curve breve

18 HeLP Hemorrhoid Laser Procedure

19 Formal Clinical Research: FDA Model Pre marketing phases Phase I healthy (or with a specific disease) volunteers (safety and dose level) Phase II subjects (drug s efficacy and effectiveness) Phase III subjects in RCT (effectiveness compared with the current best treatment)

20 Ethics & Innovative Surgery FDA Model Formal structured system by which new drugs are developed, tested and approved Formalized protection of human subject in research (Declaration of Helsinki, etc.) Surgical Model Informal system by which individual surgeons innovate independently Patients protection in innovative surgery are informal and rely primarily on the surgeon s competence nd integrity Minimal formal research on safety, efficacy and effectiveness

21 Surgical Model of Innovation Minor modification of accepted procedure / New surgical techniques From appendectomy, anesthesia, asepesis open-heart surgery, coronary by-pass surgery, solid organ transplantation To laparoscopic cholecystectomy, laparoscopic assisted colectomy Standard of care before formalized controlled clinical trial Ethical regulations for innovative surgery: the last frontier? Reitsma AM et al. J Am Coll Surg 2002; 194(6): The current system of definitions, ethical theories and voluntary professional guidelines may be inadequate to meet the challenge of surgical innovation

22 Surgical Model of Innovation The Chicago Model 1. Assuring the scientific soundness of the approach and the capability of the surgical team 2. Public disclosure of the approach (3 months before the first operation) 3. A formal IRB-approved 20-patients prospective protocol study (publication of the results regardless of outcome) 4. Three-stage informed consent process (Marron et al., Dis Colon Rectum 2005)

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