NCT02102217

Brief Summary

20% of patients who undergo major abdominal surgery will have a major complication, which requires invasive treatment and is associated with increased mortality, morbidity, hospital stay and intensive care stay. A quality control algorithm after Major Abdominal Surgery (MAS) aimed at early identification of patients at risk of developing major complications can decrease associated morbidity and mortality. Literature studies show promising results for C-reactive protein as an early marker for postoperative complications, however clinical significance has yet to be determined. Here the investigators propose a randomized clinical trial in order to determine the effect of postoperative monitoring with standardized CRP measurements on postoperative morbidity and mortality, if CRP levels exceed 140 mg/L additional CT-scan imaging will be conducted.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
525

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
1.7 years until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

4.4 years

First QC Date

March 19, 2014

Last Update Submit

November 5, 2020

Conditions

Postoperative Complications

Keywords

Major Abdominal SurgeryC-reactive proteinComputed TomographyQuality ControlPostoperative complications

Outcome Measures

Primary Outcomes (1)

  • Morbidity and mortality after major complications

    Combined Primary outcome, entailing both: 1. Mortality; during 12 month follow-up 2. Morbidity associated with major complications and after reoperation within 12 months after index operation. Including: Fistula, Wound dehiscence/incisional hernia/open abdomen, bowel obstruction or herniation, abscess, abdominal compartment syndrome, perforation of visceral organ, unplanned enterostomy, enterostomy dysfunction due to prolapse, stenosis or retraction, myocardial infarction, pulmonary embolus, respiratory insufficiency; necessitating mechanical ventilation, cerebrovascular accident, renal failure, urosepsis; urinary tract infection with positive urine and blood cultures and circulatory shock, upper GI bleeding needing intervention of any type, intra-abdominal bleeding, anastomotic leak after relaparotomy

    one year

Secondary Outcomes (5)

  • Quality of life questionnaires

    3,5 days, 3 and 12 months postoperatively

  • Add-on value of CRP

    postoperative days 3,4 and 5

  • Length of stay

    Up to one year after randomization

  • Length of Intensive Care admission

    up to one year after randomization

  • Cost-efficiency

    one year

Study Arms (2)

Precious arm

EXPERIMENTAL

Postoperative controls according to the PRECious protocol, which entails standardized measurement of CRP levels on postoperative day three, four and five. If CRP levels exceed 140 mg/l additional CT-scan imaging will be conducted.

Procedure: PRECious

Control

NO INTERVENTION

Standard postoperative controls. Additional testing will only be conducted on demand.

Interventions

PRECiousPROCEDURE

Standardized measurement of serum CRP levels on postoperative day 3,4 and 5.

Precious arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age equal to or above 18 years
  • Planned elective MAS
  • Written and oral informed consent

You may not qualify if:

  • Acute MAS
  • ASA classification equal to four or higher
  • Insufficient Dutch language skills
  • contrast allergies
  • glomerular filtration rate (GFR) \< 60 ml/min/1,73m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VU Medical Center

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Related Publications (1)

  • Straatman J, Cuesta MA, Schreurs WH, Dwars BJ, Cense HA, Rijna H, Sonneveld DJ, den Boer FC, de Lange-de Klerk ES, van der Peet DL. The PRECious trial PREdiction of Complications, a step-up approach, CRP first followed by CT-scan imaging to ensure quality control after major abdominal surgery: study protocol for a stepped-wedge trial. Trials. 2015 Aug 28;16:382. doi: 10.1186/s13063-015-0903-y.

    PMID: 26314740DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jennifer Straatman, MD

    VU Medisch Centrum

    PRINCIPAL INVESTIGATOR

  • Donald van der Peet, MD, PhD

    VU Medisch Centrum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Drs. J. Straatman

Study Record Dates

First Submitted

March 19, 2014

First Posted

April 2, 2014

Study Start

December 1, 2015

Primary Completion

May 1, 2020

Study Completion

September 1, 2020

Last Updated

November 6, 2020

Record last verified: 2020-11

Locations

NL(1)