Can Biomarkers Aid in the Prediction of Postoperative Pain and Circulatory Instability After Major Abdominal Surgery?

NCT ID: NCT02563652

Last Updated: 2018-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-09-30

Brief Summary

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Patients undergoing major surgery are exposed to extensive damage of tissues, which induces widespread activation of the inflammatory system, called 'systemic inflammatory response syndrome' (SIRS).This activation of the inflammatory system may induce instability of the heart and respiration in the postoperative period. The degree of physiologic response to postoperative SIRS as well as the degree of postoperative pain differ between patients. Therefore, patients undergoing anesthesia and major surgery are treated in a 'post anesthesia care unit' (PACU) after end of surgery.Admittance to a PACU is expensive. The time patients need to stay in a PACU after major surgery has not been extensively studied, and more appropriate tools for prediction of length of stay are needed.

The main aim of this study is to assess whether clinical observations, inflammatory biomarkers or genetic markers may aid in the prediction of physiological instability and/or pain after major surgery. Such predictors would help clinicians planning the length of PACU-stays.

Detailed Description

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Conditions

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Systemic Inflammatory Response Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Major abdominal surgery

Patients undergoing major abdominal surgery (laparotomy). Surgical procedures considered for inclusion include, but are not restricted to, procedures such as gastrectomy, pancreatic surgery, liver resection, open prostatectomy, colonic surgery, radical cystectomy with ileal conduit, open nephrectomy and vascular abdominal aortic surgery.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing major abdominal surgery (e.g. Whipple's operation, liver resection, abdominoperineal resection, vascular abdominal surgery etc.)
* Scheduled for PACU stay first 24 hours

Exclusion Criteria

* Pregnancy
* Jehovah's witness
* Dementia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Parma

OTHER

Sponsor Role collaborator

Study in Multidisciplinary Pain Research Group, Italy

UNKNOWN

Sponsor Role collaborator

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erik SolligÄrd, phd md

Role: STUDY_DIRECTOR

St. Olavs Hospital

Locations

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University of Parma

Parma, , Italy

Site Status

St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Italy Norway

Other Identifiers

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2015/641

Identifier Type: -

Identifier Source: org_study_id

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