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

ISRCTN	ISRCTN51729393
DOI	https://doi.org/10.1186/ISRCTN51729393
Protocol serial number	948-02-028
Sponsor	Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) - Health Care Efficiency Research programme

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mrs Marja A. Boermeester
Scientific

Academic Medical Center
Department of Surgery (room G4-127)
Gastrointestinal Surgery (GI infection)
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Email	m.a.boermeester@amc.uva.nl

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	RELAP trial
Study objectives	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).
Health condition(s) or problem(s) studied	Secondary peritonitis
Intervention	Planned relaparotomy versus relaparotomy on demand
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/08/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	222
Key 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
Key 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
Date of first enrolment	01/12/2001
Date of final enrolment	31/08/2006

Academic Medical Center

Amsterdam
1105 AZ
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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