Diverticulitis, Diverticular disease, Divertikelziekte, Divertikels, Hartmann, Hartmann's procedure, Primary anastomosis, Primaire anastomose, Laparoscopic lavage, Laparoscopische lavage, Hinchey III, Hinchey IV, Purulent peritonitis, Faecal peritonitis, Purulente peritonitis, Faecale peritonitis
Conditions
Interventions
All included patients are examined by laparoscopy. Patients with purulent peritonitis are randomised between laparoscopic lavage, open sigmoidresection with primary anastomosis with or without protect
Sponsors
Academic Medical Center, Amsterdam
Initiator: Prof. Dr. W.A. Bemelman
Erasmus Medical Center, Rotterdam,
Initiator: Prof. Dr. J.F Lange
Eligibility
Inclusion criteria
Inclusion criteria: 1. Clinical suspicion for perforated diverticulitis; 2. Free abdominal gas on CT-scan or plain abdominal X-ray OR peritonitis with diffuse gas or fluid on CT-scan; 3. Patient between 18-85 years; 4. Informed Consent.
Exclusion criteria
Exclusion criteria: 1. Prior Sigmoidresection; 2. Dementia; 3. Shock: requirement of inotropics for circulatory stabilisation; 4. Steroid treatment >20mg/day; 5. Pelvic irradiation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. (LOLA-arm) 1 year combined endpoint of major morbidity and mortality for patients randomised between laparoscopic lavage or open resection; 2. (DIVA-arm) 1 year stoma free survival for patients randomised between Hartmann's procedure or sigmoidresection with primary anastomosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Operating time; 2. Hospital Stay; 3. Number of days alive and outside the hospital; 4. Incisional hernia rate; 5. Number of reinterventions; 6. Quality of Life; 7. Cost-effectiveness. | — |
Contacts
Public ContactH.A. Swank
Heelkunde G4-144 Postbus 22660
Outcome results
None listed