perforated diverticulitis
Conditions
Interventions
In case of purulent diverticulitis laparoscopic lavage is compared with either
sigmoidectomy with colostomy or sigmoidectomy with anastomosis with
defunctioning loop ileostomy (LOLA arm). In case of
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient between 18 and 85 years of age Free abdominal air on plain abdominal X-ray or CT-scan Informed consent
Exclusion criteria
Exclusion criteria: Dementia Prior sigmoidectomy Pelvic irradiation Steroid treatment >20mg daily Requirement of inotropics due to circulatory insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following main outcomes will be assessed in this trial to compare the various strategies: Poor clinical outcome defined as a combined endpoint consisting of mortality, and major morbidity. Major morbidity includes any of the following events or conditions: reintervention, wound dehiscence/incisional hernia, abscess needing percutaneous drainage, urosepsis, myocardial infarction, renal failure and respiratory insufficiency. This will be the primary outcome in the lavage vs. resectional intervention comparison (LOLA). Stoma-free survival one year after initial surgery, is the only relevant and primary outcome for the comparison of the resectional strategies (DIVA). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are operating time, hospital stay, number of days alive and outside the hospital, incisional hernia, reinterventions within twelve months, health related quality of life, health care utilization and associated costs. | — |
Countries
Netherlands
Outcome results
None listed