The effect of an intraoperative, goal-directed volume protocol in abdominal surgery within an accelerated recovery program after surgery (Enhanced Recovery Program After Surgery- = ERAS-Program).

Recruiting

• Conditions: colonic surgery; 10017990

• Registration Number: NL-OMON33620
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

- Written patient consent
- Patients which
- undergo colonic resection above
the peritoneal reflection.
- are treated within the context of
an accelerated post-operative
recovery program.

Exclusion Criteria

Accommodation in an institute due to an official or judicial order
- No written consent from patient
- Unwillingness to allow storage and sharing of anonymised disease data in the context of the clinical study
- Simultaneous participation of the patient in another study or having been in a study which was terminated less than one week before.
- ASA >III
- Advanced disease of the oesophagus of nasopharyngeal cavity
-Operations in the area of the oesophagus or nasopharynx within the last 3 months
- Systemic steroid therapy
- Moderate or severe heart valve disease
- von Willebrands disease
- history of bleeding tendency
- Liver disease (Child B or C cirrhosis, MELD score >17 [9,10])
- Age <18 years
- Renal failure (serum creatinine >2.0mg/dL)
- Chronic heart failure NYHA III or IV
- history of intracranial haemorrhage
- Allergy to hydroxy-ethyl starch

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Hypothesis:<br /><br>In contrast to a liberal volume management strategy there is a difference in<br /><br>the amount of intravenously administered crystalloid and colloid fluid on the<br /><br>day of operation compared to a goal-directed volume protocol within an<br /><br>accelerated surgical recovery program (Enhanced Recovery After Surgery-Program<br /><br>= ERAS-Program). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Hypothesis:<br /><br>The goal-directed perioperative fluid therapy reduces the intraoperative<br /><br>requirement for vasoactive drugs, the time to hospital discharge and the rate<br /><br>of postoperative complications (pain, delirium. infections, cardiac, pulmonary,<br /><br>gastrointestinal and renal dysfunction). </p><br>