Condition category
Digestive System
Date applied
10/02/2004
Date assigned
30/03/2004
Last edited
03/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Secondary peritonitis

Intervention

Planned relaparotomy versus relaparotomy on demand

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

‘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 trial start date

01/12/2001

Overall trial end date

31/08/2006

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1.Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17712070
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22196238

Publication citations

  1. Results

    van Ruler O, Kiewiet JJ, Boer KR, Lamme B, Gouma DJ, Boermeester MA, Reitsma JB, Failure of available scoring systems to predict ongoing infection in patients with abdominal sepsis after their initial emergency laparotomy., BMC Surg, 2011, 11, 38, doi: 10.1186/1471-2482-11-38.

  2. 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, , Comparison of on-demand vs planned relaparotomy strategy in patients with severe peritonitis: a randomized trial., JAMA, 2007, 298, 8, 865-872, doi: 10.1001/jama.298.8.865.

Additional files

Editorial Notes