Noventa Day Surgery 2013 25 Maggio 2013

Procto Day Meccanica PPh Cristiano Finco

PROCTO DAY NOVENTA

Chirurgia Transanale Stapler Assistita

�  Nascita della la teoria unitaria del prolasso e della mucoprolassectomia

con PPH per malattia emorroidaria

Longo A: Proceedings of VI°International congress of EAES Rome 777-784 1998

�  Definizione della chirurgia del prolasso interno del retto e della ostruita defecazione con tecnica STARR

Longo A . Proceedings of Annual Cleveland clinic Smposium Florida 2004 Boccasanta P,Venturi M,stuto A et al. Dis Colon &Rectum 47.1285-1296 2004

 

Evoluzione Stapled Anopexy

�  1° periodo : Fattibilità �  2° periodo : Complicanze �  3 °periodo : 2006-2007 -Grandi metaanalisi di

confronto ¡  PPH vs Conventional

�  4 °periodo : Bleeding & Recurrence ¡  Bleeding :progettazione PPH03 per emostasi ¡  Recurrence: doppia stapler

�  5 ° periodo : Nuovi progetti ¡  Bleeding: nuove soluzioni tecniche ¡  Recurrence: Alto Volume

LETTERATURA 2006-2007: GRANDI REVIEW

Jayaraman S, Colquhoun PHD, Malthaner RA. Stapled hemorrhoidopexy is associated with a higer long-term recurrence rate of internal hemorrhoids compared with conventional excisional hemorroid surgery. Dis Colon Rectum 2007; 50: 1297-1305.

National Institute for Health and Clinical Excellence. Stapled haemorrhoidopexy for the treatment of haemorrhoids. Final appraisal determination. 2007

Tjandra JJ, Miranda KYC. Systematic review on the procedure for prolapse and hemorrhoids (stapled hemorrhoidopexy). Dis Colon Rectum 2007; 50:878-892

Jayaraman S, Colquhoun PHD, Malthaner RA. Stapled versus conventional surgery for Hemorrhoids (Review). Cochrane 2006

CIRCULAR STAPLED HAEMORRHOIDECTOMY NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE, 2007

OUTCOMES:CUMULATIVE COMPLICATIONS:

• Suture dehiscence

• Haemorrhage

• Submucosal haematoma

• Fistula and septic complications

• Anal and perineal Pain • Urgency • Rectal Stenosis • Incontinence • Pruritus • Recurrent Prolapse

STAPLED HAEMORRHOIDECTOMYFOR THE TREATMENT OF HAEMORRHOIDS

NICE 2007

Stapled Haemorroidectomy vs Conventional Haemorroidectomy

PAIN

• STATISTICALLY SIGNIFICANT REDUCTION WITH STAPLED in 95% OF STUDIES

• STATISTICALLY SIGNIFICANT REDUCTION WITH STAPLED IN SHORT AND MEDIUM - TERM POSTOPERATIVE

STAPLED HAEMORRHOIDECTOMYFOR THE TREATMENT OF HAEMORRHOIDS NICE 2007

Stapled Haemorroidectomy vs Conventional Haemorroidectomy

RECURRENT PROLAPSE

• STATISTICALLY SIGNIFICANT RATE OF RECURRENT PROLAPSE BETWEEN 1-8 WEEKS WITH STAPLED

STAPLED HAEMORRHOIDECTOMYFOR THE TREATMENT OF HAEMORRHOIDS

NICE final appraisal, 2007

Stapled Haemorroidectomy vs Conventional Haemorroidectomy

CONCLUSIONS (1) • NO STATISTICALLY SIGNIFICANT DIFFERENCE FOR POST-OPERATIVE COMPLICATION

STAPLED HAEMORRHOIDECTOMYFOR THE TREATMENT OF HAEMORRHOIDS

NICE 2007

Stapled Haemorroidectomy vs Conventional Haemorroidectomy

CONCLUSIONS (2)

• SHORTER TIME TO RETURN TO NORMAL BOWEL FUNCTION IN STAPLED

• SHORTER WHOUND HEALING TIME IN STAPLED

• EARLIER RETURN TO NORMAL ACTIVITY IN STAPLED

CIRCULAR STAPLED HAEMORRHOIDECTOMY NICE, final appraisal 2007

CONCLUSIONS

“ Statements from patient experts and clinical specialists asserted that stapled haemorrhoidopexy is considerably less painful

postoperatively than conventional haemorrhoidectomy and that people can return to work and normal lifestyle sooner after stapled

haemorrhoidopexy compared with conventional haemorrhoidectomy”

“ Including costs of postoperative pain management, cost analysis would favour stapled haemorrhoidopexy in the economic

model”

CIRCULAR STAPLED HAEMORRHOIDECTOMY NICE, final appraisal 2007

CONCLUSIONS “The Commitee agreed that stapled haemorrhoidopexy was likely to be as effective as conventional haemorrhoidectomy when used

appropriately and offered immediate benefit in terms of postoperative pain.”

“Taking into account requirements for postoperative management and other support during patient stay and after discarge, stapled haemorrhoidopexy might lead to modest cost

saving ”

“ Stapled haemorrhoidopexy is an appropriate use of NHS resource”

Stapled Anopexy

�  Stapled Anopexy has been associated with less postoperative pain and earlier return to normal activity than conventional haemorrhoidectomy, toghether with the higher satisfaction rate of pts and higher quality of life scores

�  In spite of low complication rate is clear evidence of failure reported as residual disease and or recurrence of symptoms after SH

�  Possible explanation are: incomplete resection of prolapsed

tissue, technical errors in performing PPH procedure, misunderstanding of significance of “recurrence”

Definition of recurrence

�  Recurrent haemorrhoids ? �  Recurrent prolapse? �  Recurrent prolapsed haemorrhoids? �  Skin tags ?

Definition �  Residual disease means reduction without disappearance of

prolapsed tissue ( prolapse or haemorrhoids)

�  Recurrence is a reappearance of symptoms after a symptoms free-period

�  Residual disease usually is > of recurrence

Meta-analisis & Sistematic reviews

Autore Anno n° RCTs Follow-up

Primary outcomes

Tjandra J 2007 15 12-84 Recurrent prolapse Bleeding

Jayaraman S 2007 12 6-48 Recurrence haemhorroids

Shao W.J 2008 28 < 12 Recurrence prolapse

Burch J 2008 27 <12 Pain, recurrent prolapse

Laughlan K 2008 29 (2 long term)

<36 Recurrent prolapse

Giordano P 2009 15 12-84 Recurrent prolapse

Short and medium term outcomes : pooled results of metaanalisis

Stapled Haemorrhoidopexy vs Conventional Haemorrhoidectomy

symptoms SH conv symptoms SH conv bleeding TT Recurrent symptoms TT pain TT Recurrent haemorrhoids TT Urinary retention TT Recurrent prolapse p Wound healing TT Skin tags TT Operation time short

TT incontinence NS NS

Hospital stay TT Anal stenosis TT Return to work p Quality of life TT

Patient satisfaction TT

Short term Medium term (< 1 year)

p Statistically significant difference in favour NS Substantially equal TT Trends toward

First Long Term Follow-Up Trials

Author Year N pts FU months

Sh recurrent prolapse

Conv recurrent prolapse

P value

Au-Yong 2003 21 42 5/11 3/9 0.57

Smyth 2003 36 37 0/20 0/16 n.s

Racalbuto 2003 100 48 2/50 0/50 ns

Vd Stadt 2003 40 46 5/20 0/20 0.04

Ganio 2006 81 84 5/44 2/37 Ns

Long term outcomes Stapled Haemorrhoidopexy vs Conventional Haemorrhoidectomy

P.Giordano et al Arch Surg 2009 144(3)266-272

Evoluzione Stapled Anopexy

�  1° periodo : Fattibilità �  2° periodo : Complicanze severe �  3 °periodo : Grandi metaanalisi di confronto

¡  PPH vs Conventional

�  4 °periodo : Bleeding & Recurrence ¡  Bleeding :progettazione PPH03 per emostasi ¡  Recurrence: doppia stapler

�  5 ° periodo : Nuovi progetti ¡  Bleeding: Aumento agraphes ¡  Recurrence: Alto Volume

STARR vs SA in the cure of haemorrhoids a ssociated with rectal prolapse A randomized Controlled trial

P. Boccasanta et al Intern. J Colorect. Dis 2007 22:245-251

�  68 pts blinding randomized in Group SH & STARR �  Mean FU 8 months

SA STARR P value

Skin Tags 20(58.8) 8 (23.5) 0.007

Rectal Prolase

10 (29.4) 2 (5.9) 0.03

STARR vs SA in the cure of haemorrhoids a ssociated with rectal prolapse A randomized Controlled trial

P. Boccasanta et al Intern. J Colorect. Dis 2007 22:245-251

� The effectiveness of surgery seemed to be strictly related to the volume of prolapsed tissue resected

� The anal dilator is a good predictive factor: a prolapse over half the lenght of the CAD is associated with a persistance of residual prolapsed tisssue if a one PPh procedure is performed

New approach to a large haemorrhoidal prolapse : double stapled haemorhoidopexy

Naldini G et al Int J Colorect Dis 2009 24 1383-1387

�  353 pts prospective study multicentric � Mean FU 48 months �  270 pts SH 83 STARR

SH 270 pts

STARR 83 pts

Total 353 pts

Residual prolapse 9/270 3.3 % 3/83 3.6% 12 (3.4%)

Recurrent prolapse 12/270 4.4% 5/83 6% 17 (4.8%)

Residual + recurrent 29 (8.2%)

Technical suggestion for SH without recurrences

�  Select patients. More than 1/ 3 of patients with the indications for haemorrhoids presented with symptoms of Obstruced Defecation

�  After anesthesia , once the anuscope is in place, observe the entity of prolapse

�  Measuring proplapse is essential �  Prolapsing mucosa more than ½ of anuscope suggest STARR

procedure more than PPH �  Dentate line is not a good anatomic marker to place the suture �  Apex of haemorroidal piles is a correct anatomic marker �  Purse string 2 cm above the apex of haemorrhoidal piles

Evoluzione Stapled Anopexy

�  1° periodo : Fattibilità �  2° periodo : Complicanze severe �  3 °periodo : Grandi metaanalisi di confronto

¡  PPH vs Conventional

�  4 °periodo : Bleeding & Recurrence ¡  Bleeding :progettazione PPH03 per emostasi ¡  Recurrence: doppia stapler

�  5 ° periodo : Nuovi progetti ¡  Bleeding: Aumento agraphes ¡  Recurrence: Alto Volume

PPH 01 PPH 03 Johnson

100

50

25

Rischio

Volume Resecato

Vantaggi

Volume resecato (cm2)

TRANSTAR

STARR

Transtar :Limiti della resezione

PPH plus 33

TST 33

TST WS

Touchstone

Caratteristiche PPH33 Plus Touchstone

�  Testina 33 mm solidale con lo stelo �  Camera di raccolta 19 cc �  2 corone concentriche da 16 punti di titanio ciascuna �  Altezza del punto regolabile da 0.75 a 1.5mm �  Precisa formazione punto di chiusura grazie all’anti retriving lock che impedisce movimenti longitudinali tra testina ed il corpo della suturatrice

CPH 34 Innova

CPH 34 INNOVA Caratteristiche

�  Volume del Case Maggiorato 25,18 cc

�  32 Agraphes per ottima emostasi

�  Case trasparente per la visualizzazione del resecato

�  4 fori posteriori per la trazione del resecato

Scelte Consapevoli per l’Innovazione Tecnologica Health Technology Assesment (HTA)

�  L’introduzione  di  innovazione  tecnologica  è  una  tendenza  difficilmente  comprimibile  per  effetto  delle  pressioni  di  mercato,  dello  sviluppo  di  professionalità,  del  ruolo  attivo  dei  pazienti    

�  L’adozione  di  nuove  tecnologie  avviene  talora  con  modalità  non  adeguatamente  governate  

�  Uno  dei  sistemi  di  governo  è  la  HTA  

�  Non  sempre  l’  HTA  è  reperibile  all’interno  di  una  regione    �  Talora  è  necessario  trovare  collaborazioni  con  gruppi  ed  esperienze  nazionali  

ed  internazionali  

Health Technology Assessment ipotesi di collaborazioni

�  PPh  nel  trattamento  del  prolasso  emorroidario    Report  HTA:  confronto  tra  due  regioni  Italiane  

   Lopatriello  S*,  Berto  S*,Schivazappa,Benvenuti  F,Boccasanta  P,BordoniL,L

 Lenisa  L,Naldini  G,Nepi  S  Todaro  A  Valeri  A    *  PBE  Consulting      

                             SIFO    2009  

   

Health Technology Assessment

�  International  Network  of  Agencies  for  HTA    -­‐  INAHTA  �  U.K                  NICE  (National  Institute  Of  Clinical  Excellence)  �  Canada    CADTH  �  Italia:  manca  un  organismo  centrale  di  HTA  �  Esperienze  embrionali  in  alcune  regioni  

¡  Carta  di  Trento  (  2006)  ¡  Lombardia  ¡  Veneto  ¡  Emilia  Romagna    ¡  Piemonte    

Conclusioni

�  La stapled anopexy rappresenta una scelta chirurgica valida con le indicazioni appropriate

�  I vantaggi a breve termine sono indiscussi �  I sanguinamenti sono ridotti grazie ai nuovi devices �  Le recidive sono una realtà e vanno discusse con il

paziente �  Le suturatrici ad alto volume rappresentano una

soluzione tecnica che può ridurre le recidive �  Sono necessarie Validazione scientifiche dei nuovi

devices

Cristiano Finco vi saluta

fine

Conclusion �  Recurrent prolapse is more frequent in PPH group than Conventional

Haemorrhoidectomy

�  In the short period PPH is preferred procedure by patients because of low pain, short hospital stay, quicker return to work ,rapid wound healing

�  In most cases Recurrence occurs < 1 year suggesting a technical error more than true recurrence

�  Recurrences has not beeen confuse with skin tags or residual prolapsing piles

�  Patients is needed to be informed about the benefits of SH toghether with the higher incidence of recurrent prolapse in the long term

Nuovi Devices

�  Bleeding : Aumento Agraphes 28 --> 32

�  Recurrence: Aumento Resecato 17.3cc --> 19 cc

SISTEMATIC REVIEW ON THE PROCEDURE FOR PROLAPSE AND HAEMORRHOIDS (STAPLED HAEMORRHOIDOPEXY)

Tjandra JJ, Dis Colon Rectum, 2007

25 RCT PPH Stapled hemorrhoidopexy vs conventional hemorrhoid surgery

SISTEMATIC REVIEW ON THE PROCEDURE FOR PROLAPSE AND HAEMORRHOIDS (STAPLED HAEMORRHOIDOPEXY)

Tjandra JJ, Dis Colon Rectum, 2007

• BLEEDING

Intraoperative / early post-op bleeding: no significant difference

After 1^ post-op: PPH significantly less risk of bleeding

Jayaraman S, Dis Colon Rectum 2007

Stapled hemorrhoidopexy vs Excisional Hemorrhoids

BLEEDING

IN FAVOR OF TRADITIONAL SURGERY BUT NO STATISTICALLY SIGNIFICANT DIFFERENCE

Stapled Prolassectomy vs. Excisional Hemorrhoids (any methods: MM, Ferguson, Parks)

12 RCTS

Results

Outcome : Recurrence

Con “conventional hemorrhoidectomy is superior to stapled hemorrhoidopexy for prevention of postoperative recurrence of internal hemorrhoids”

Jayaraman S, Dis Colon Rectum 2007