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Program – Introduction and status of SCANDIV

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Presentation on theme: "Program – Introduction and status of SCANDIV"— Presentation transcript:

0 Welcome to Gardermoen

1 Program 11.00 – 11.30 Introduction and status of SCANDIV
11.30 – Report from the Dutch diverticulitis trail (Hilco Swank) 12.45 – Discussion 13.00 – Lunch 13.45 – Discussion

2 Background Hinchey grading Prevalence Incidence Existing research

3 Perforated diverticulitis
Hinchey grading (Hinchey et al. 1978)

4 Prevalence Diverticulosis Diverticulitis Raising with age
> 60 years of age: 30-50% Diverticulitis 10-30% of those with diverticulosis: Conservative/medical treatment: 75-90% Surgical intervention: 10-30% 10 – 30 % of all patients with diverticulosis will experience one or more episodes of diverticulitis through their lifetime. 50% divertikulos 20% divertikulit = 10% Kirurgi 20 % = 2/100 4 4

5 Population Demography

6 Incidence Diverticulitis: Ca 20-40/100.000/year
Acute perforated diverticulitis: Ca 3-5/ /year

7 Surgical options Three stages 1. Drainage and transversostomy Sigmoid resection 3. Closure of stoma Hartmann Sigmoid resection with sigmoidostomy 2. Closure of stoma with colorectal anastomosis Resection with primary anastomosis (with or without diverting stoma) Laparoscopic lavage

8 Mortality Hospital mortality after emergency surgery for perforated diverticulitis England: ’Hospital Episode Statistics’ database between 1996 and 2006 Emergency surgery for sigmoid diverticular disease 30-day mortality / pts = 15.9% Alim Pharm Therapeutics 2009;30:

9 Rationale • E. Myers et. al., BJS 2008
“Laparoscopic peritoneal lavage for generalized peritonitis due to perforated diverticulitis” Laparoscopy in 100 patients with perforated diverticulitis - laparoscopic lavage in 92 patients - 8 patients converted to Hartmann due to faecal peritonitis Mortality 3%, morbidity 4% in the lavage group • Similar results in other papers with fewer patients

10 But No randomized studies

11 Randomized prospective multicenter trial
Laparoscopic lavage vs. primary resection as treatment for perforated diverticulitis Start of inclusion February 2010 28 hospitals participate 42 patients included

12 Endpoints Secondary Primary
- severe complications within 90 days (Clavien-Dindo >IIIa ) power analysis 30 % v.s. 10 % complications = 130 pts Aim = 150 patients Secondary - duration of procedure - time spent in hospital - complications individually - stoma one year after initial surgery - “Cleveland Global Quality of Life” - costs

13 Inclusion Inclusion criteria Exclusion criteria - age >18 years
- clinical signs of perforated diverticulitis and need for surgery - CT displays free gas and possible diverticulitis - the patient tolerates general anaesthesia - the patient has given written informed consent Exclusion criteria - pregnancy - bowel obstruction

14 Techniques In all cases, lavage with minimum 4 l saline, wound drain and Hinchey grading Laparoscopic lavage usual port placement: umbilicus, suprapubic, right lower quadrant faecal peritonitis (including visible hole) convert to Hartmann adhesions to the sigmoid should not be dealt with Sigmoid resection with or without stoma, open or laparoscopic

15 Randomization

16

17 Participating hospitals

18 SCANDIV approximate catchment population (educated guess)
Borås Lasarett Danderyd sjukhus, Stockholm Diakonhjemmet sykehus Haugesund sykehus Haukeland Sykehus Helsingborgs lasarett Hudiksvalls sjukhus   Innlandet sykehus, Hamar Innlandet sykehus, Lillehammer Karolinska sjukhuset, Stockholm Huddinge Solna Kristiansund Sykehus   Linköpings universitetssjukhus Levanger Sykehus Malmø Akademiska sjukhus (Skånes universitetssjukhus) Norrköping, Vrinnevisjukhuset Molde sykehus Oslo universitetssykehus, Aker Oslo universitetssykehus, Ullevål ‎ Stavanger Universitetssykehus Sørlandet sykehus, Kristiansand Sykehus Østfold Fredrikstad UNN, Tromsø Uppsala Akademiska sjukhus Umeå universitetssjukhus Västerås Centrallasarettet Vestre Viken HF Sykehuset Buskerud Akershus Universitetssykehus Ålesund sykehus Total population ≈ ? 150 patients/year with perforated diverticulitis?

19 Included patients

20 Patients per hospital

21 Case report forms

22 Case report form, follow-up

23 Patient information and consent

24 Web - CRF Web based Case Report Form Testing next week
Hope to start after Easter Changes in patient information?


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