Noventa Day Surgery 2013 - Società Triveneta di Chirurgia

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 versus conventional
surgery for Hemorrhoids (Review). Cochrane 2006
Tjandra JJ, Miranda KYC. Systematic review on the procedure for prolapse and
hemorrhoids (stapled hemorrhoidopexy). Dis Colon Rectum 2007; 50:878-892
National Institute for Health and Clinical Excellence. Stapled haemorrhoidopexy for
the treatment of haemorrhoids. Final appraisal determination. 2007
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.
CIRCULAR STAPLED HAEMORRHOIDECTOMY
NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE, 2007
OUTCOMES:CUMULATIVE COMPLICATIONS:
• Anal and perineal Pain
• Suture dehiscence
• Urgency
• Haemorrhage
• Rectal Stenosis
• Submucosal haematoma
• Incontinence
• Fistula and septic complications
• 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
Short term
symptoms
SH
bleeding
conv
TT
Medium term (< 1 year)
symptoms
SH
conv
Recurrent symptoms
TT
TT
pain
TT
Recurrent haemorrhoids
Urinary retention
TT
Recurrent prolapse
p
Wound healing
TT
Skin tags
TT
Operation time
short
TT
incontinence
NS
Hospital stay
TT
Anal stenosis
p
Quality of life
TT
Patient satisfaction
TT
Return to work
p
NS
TT
Statistically significant difference in favour
Substantially equal
Trends toward
NS
TT
First Long Term Follow-Up Trials
Author
Year
N pts
FU
months
Sh
recurrent
prolapse
Conv
recurrent
prolapse
P
valu
e
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
Transtar :Limiti della resezione
Volume resecato (cm2)
100
TRANSTAR 50
STARR 25
Rischio
Volume Resecato
Vantaggi
Touchstone
PPH plus 33
TST 33
TST WS
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)
25 RCT PPH Stapled hemorrhoidopexy vs
conventional hemorrhoid surgery
Tjandra JJ, Dis Colon Rectum, 2007
SISTEMATIC REVIEW ON THE PROCEDURE FOR PROLAPSE AND
HAEMORRHOIDS
(STAPLED HAEMORRHOIDOPEXY)
• BLEEDING
Intraoperative / early post-op bleeding: no significant
difference
After 1^ post-op: PPH significantly less risk of bleeding
Tjandra JJ, Dis Colon Rectum, 2007
Stapled hemorrhoidopexy vs Excisional
Hemorrhoids
BLEEDING
IN FAVOR OF TRADITIONAL SURGERY
BUT NO STATISTICALLY SIGNIFICANT
DIFFERENCE
Jayaraman S, Dis Colon Rectum 2007
Stapled Prolassectomy vs. Excisional Hemorrhoids
(any methods: MM, Ferguson, Parks)
12 RCTS
Results
Outcome : Recurrence
“conventional hemorrhoidectomy is superior to
Con
stapled hemorrhoidopexy
for prevention of
postoperative recurrence of internal hemorrhoids”
Jayaraman S, Dis Colon Rectum 2007