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ISRCTN
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ISRCTN51729393
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ClinicalTrials.gov identifier
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Public title
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Planned relaparotomy versus relaparotomy on demand in abdominal sepsis: a randomised, multi-center, clinical trial
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Scientific title
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Acronym
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RELAP trial
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Serial number at source
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948-02-028
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Study hypothesis
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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.
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Ethics approval
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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).
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Study design
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Randomised controlled trial
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Countries of recruitment
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The Netherlands
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Disease/condition/study domain
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Secondary peritonitis
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/12/2001
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Anticipated end date
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31/08/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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222 (+12 additional for anticipated drop-outs)
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Interventions
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Planned relaparotomy versus relaparotomy on demand
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Primary outcome measure(s)
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‘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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) - Health Care Efficiency Research programme
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Trial website
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Publications
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Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17712070
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Contact name
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Mrs
Marja A.
Boermeester
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Address
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Academic Medical Center
Department of Surgery (room G4-127)
Gastrointestinal Surgery (GI infection)
Meibergdreef 9
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City/town
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Amsterdam
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Zip/Postcode
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1105 AZ
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Country
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Netherlands
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Email
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m.a.boermeester@amc.uva.nl
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Sponsor
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Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
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Address
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Laan van Nieuw Oost Indie 334
P.O. Box 93245
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City/town
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The Hague
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Zip/Postcode
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2509 AE
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Country
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Netherlands
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Tel
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+31 (0)70 349 5111
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Fax
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+31 (0)70 349 5100
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Email
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info@zonmw.nl
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Date applied
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10/02/2004
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Last edited
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24/08/2007
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Date ISRCTN assigned
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30/03/2004
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