Welcome to Gardermoen

Program 11.00 – 11.30 Introduction and status of SCANDIV 11.30 – 12.15 Report from the Dutch diverticulitis trail (Hilco Swank) 12.45 – 13.00 Discussion 13.00 – 13.45 Lunch 13.45 – 15.00 Discussion

Background Hinchey grading Prevalence Incidence Existing research

Perforated diverticulitis Hinchey grading (Hinchey et al. 1978)

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

Population Demography

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

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

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 1.923 / 12.121 pts = 15.9% Alim Pharm Therapeutics 2009;30: 1171-1182

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

But No randomized studies

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

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

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

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

Randomization www.scandiv.com

Participating hospitals

SCANDIV approximate catchment population (educated guess) Borås Lasarett 200000 Danderyd sjukhus, Stockholm 450000 Diakonhjemmet sykehus 50000 Haugesund sykehus 70000 Haukeland Sykehus 300000 Helsingborgs lasarett 200000 Hudiksvalls sjukhus   50000 Innlandet sykehus, Hamar 200000 Innlandet sykehus, Lillehammer 100000 Karolinska sjukhuset, Stockholm Huddinge 300000 Solna 150000 Kristiansund Sykehus   50000 Linköpings universitetssjukhus 175000 Levanger Sykehus 70000 Malmø Akademiska sjukhus 600000 (Skånes universitetssjukhus) Norrköping, Vrinnevisjukhuset 200000 Molde sykehus 70000 Oslo universitetssykehus, Aker 70000 Oslo universitetssykehus, Ullevål ‎ 200000 Stavanger Universitetssykehus 150000 Sørlandet sykehus, Kristiansand 150000 Sykehus Østfold Fredrikstad 200000 UNN, Tromsø 150000 Uppsala Akademiska sjukhus 150000 Umeå universitetssjukhus 100000 Västerås Centrallasarettet 150000 Vestre Viken HF Sykehuset Buskerud 100000 Akershus Universitetssykehus 450000 Ålesund sykehus 125000 Total population ≈ 5.000.000 ? 150 patients/year with perforated diverticulitis?

Included patients www.scandiv.com

Patients per hospital www.scandiv.com

Case report forms www.scandiv.com

Case report form, follow-up www.scandiv.com

Patient information and consent www.scandiv.com

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