Perforated diverticulitis Digestive System Other diseases of stomach and duodenum
Conditions
Interventions
1. Laparoscopy and peritoneal lavage and drainage: surgery consists of a laparoscopy of the abdomen with lavage using at least 3 litres of saline, until clear return fluid is achieved, after this a dr
dependent on the time taken for the above procedures. This treatment is only used in patients with an emergency situation of perforated diverticulitis.
Amended 10/05/2010:
All operations start with
Sponsors
Sahlgrenska University Hospital (Sweden) - Department of Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with acute diverticulitis (no age limits, either sex) 2. Intra-abdominal fluid or gas on computed tomography (CT) 3. Decision by the surgeon to perform emergency surgery 4. Possible to operate in regard to concomitant disease 5. Informed consent Amended 10/05/2010: The ethical committees have given permission for patients who are unable to give informed consent due to the diverticulitis, to be included until such time postoperatively when they can be duly informed and then give an informed consent or withdraw the presumed consent.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 30/06/2011: 1. Exclusion criteria: 1.1. Not possible to operate due to concomitant disease 1.2. Participation in other randomized trials in conflict with the protocol and end-points of the DILALA trial 2. Randomization: criteria 2.1. Perforated diverticulitis Hinchey grad III at diagnostic laparoscopy 3. Exclusion from randomization: criteria 3.1. Hinchey grade I - II at laparoscopy i.e. no free fluid/pus in the abdomen ? no further surgical procedure 3.2. Hinchey grade IV at laparoscopy, i.e. gross faecal contamination will be converted to open surgical procedure with resection and stoma formation 3.3. Other pathology than perforated diverticulitis, for example perforated appendicitis or stomach ulcer. 4. Exclusion after randomization 4.1. Withdrawn consent 4.2. Cancer diagnosed in resected specimen (only possible in randomised to Hartmann?s procedure) 4.3. Cancer diagnosed at colonoscopy after initial episode 5. Intention to treat 5.1. All patients randomised in accordance with randomization criteria and not excluded correctly after randomization (criteria for this see above) will be analysed in group of randomization. This means that patients randomized to laparocopic lavage and converted to open surgery will be analysed in the 'laparoscopic lavage group' Previous exclusion criteria: 1. Patients not possible to operate due to concomitant disease 2. Hinchey grade I - II at laparoscopy i.e. no free fluid - no further surgical procedure 3. Hinchey grade IV at laparoscopy, i.e. gross faecal contamination will be converted to open surgical procedure with resection and stoma formation 4. Participation in other randomised trials in conflict with the protocol and end-points of this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 17/12/2013: Percentage of patients who were re-operated within 12 months Previous primary outcome measures: Number of operations within 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Re-admission: within 12 months from emergency diverticulitis 2. Post-operative infections: any point of time within 12 months of primary surgical procedure 3. Thrombosis: any point of time within 12 months of primary surgical procedure 4. Other complications: any point of time within 12 months of primary surgical procedure 5. Hernia: any point of time within 12 months of primary surgical procedure 6. Bowel obstruction: any point of time within 24 months of primary surgical procedure 7. Length of hospital stay: total time in hospital within 12 months 8. Quality of life: at discharge from hospital, at 6 and 12 months after primary emergency surgery 9. Health economy: at 12 and 24 months after primary surgical procedure 10. Mortality: within 28 days and 12 months after primary surgical procedure 11. Permanent stoma: at 12 months those with a persistent stoma are judged as 'permanent' 12. Re-admissions and re-operations: within 24 months; as found in hospital/national registries with appropriate International Classification of Diseases (ICD) coding Added 17/12/2013: 13. Total number of operations in test and control groups, respectively, within 12 and 24 months | — |
Countries
Denmark, Norway, Sweden
Outcome results
None listed