Planned relaparotomy versus relaparotomy on demand in abdominal sepsis: a randomised, multi-center, clinical trial

Conditions

Secondary peritonitis Digestive System Peritonitis

Opmeer BC, Boer KR, van Ruler O, Reitsma JB, Gooszen HG, de Graaf PW, Lamme B, Gerhards MF, Steller EP, Mahler CM, Obertop H, Gouma DJ, Bossuyt PM, de Borgie CA, Boermeester MA.

2010-05-2722 citations

10.1186/cc9032

Comparison of on-demand vs planned relaparotomy strategy in patients with severe peritonitis: a randomized trial.

van Ruler O, Mahler CW, Boer KR, Reuland EA, Gooszen HG, Opmeer BC, de Graaf PW, Lamme B, Gerhards MF, Steller EP, van Till JW, de Borgie CJ, Gouma DJ, Reitsma JB, Boermeester MA, Dutch Peritonitis Study Group.

2007-08-01188 citations

10.1001/jama.298.8.865

Interventions

Planned relaparotomy versus relaparotomy on demand

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with secondary peritonitis 2. Between 18 and 80 years 3. An Acute Physiology And Chronic Health Evaluation (APACHE) II score more than 10 (worst score in the first 24 hours of diagnosis) Participating centres: 1. Academic Medical Center Amsterdam 2. University Medical Center Utrecht 3. Gelre Hospital Apeldoorn 4. Onze Lieve Vrouwe Gasthuis (OLVG) Amsterdam 5. St Lucas Andreas Hospital Amsterdam 6. Isala Klinieken Zwolle 7. A. Schweitzer Hospital Dordrecht 8. Bosch Medisch Centrum Den Bosch 9. Reinier de Graaf Gasthuis Delft

Exclusion criteria

Exclusion criteria: 1. Age less than 18 or more than 80 years 2. Abdominal infection due to perforation after endoscopy operated within 24 hours 3. Abdominal infection due to an indwelling dialysis (Continuous Ambulatory Peritoneal Dialysis [CAPD]) catheter 4. Acute pancreatitis 5. Index laparotomy for peritonitis in another (referring, non-participating) hospital 6. Expected survival less than six months due to disseminated malignancy 7. Brain damage due to trauma or anoxia

Design outcomes

Primary

Measure	Time frame
?Poor outcome? defined as death (all-cause mortality) or, in survivors, readmission or surgical intervention for disease-related morbidity (i.e., morbidity related to abdominal sepsis and its treatment) during a 180-day period after index laparotomy.	—

Secondary

Measure	Time frame
1. Duration of mechanical ventilation, Intensive Care Unit (ICU) and hospital stay, days outside the hospital in one year after index surgery, long-term morbidity (one year), quality of life, and Quality-Adjusted Life-Years (QALYs). 2. Medical and indirect costs comparing absolute volumes of resource utilization.	—

Countries

Netherlands

Outcome results

None listed