Contact information
Type
Scientific
Contact name
Mrs Marja A. Boermeester
ORCID ID
Contact details
Academic Medical Center
Department of Surgery (room G4-127)
Gastrointestinal Surgery (GI infection)
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
m.a.boermeester@amc.uva.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
948-02-028
Study information
Scientific title
Acronym
RELAP trial
Study hypothesis
Relaparotomy on demand strategy in patients with secondary peritonitis reduces the risk of 180-day poor outcome (death or readmission/surgical intervention for morbidity in survivors) compared to a strategy with planned relaparotomy.
Ethics approval(s)
Approved by the Medical Ethics Committee, Academic Medical Center, Amsterdam, The Netherlands and by the Dutch Central Committee on Research Involving Human Subjects (Dutch initials: CCMO).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Secondary peritonitis
Intervention
Planned relaparotomy versus relaparotomy on demand
Intervention type
Other
Primary outcome measure
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 outcome measures
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.
Overall study start date
01/12/2001
Overall study end date
31/08/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Not Specified
Target number of participants
222 (+12 additional for anticipated drop-outs)
Participant 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
Recruitment start date
01/12/2001
Recruitment end date
31/08/2006
Locations
Countries of recruitment
Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Sponsor details
Laan van Nieuw Oost Indie 334
P.O. Box 93245
The Hague
2509 AE
Netherlands
+31 (0)70 349 5111
info@zonmw.nl
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) - Health Care Efficiency Research programme
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 1.Results | 22/08/2007 | Yes | No | |
| Results article | results | 23/12/2011 | Yes | No |