KOREAN Enhanced RecOvery Strategy for Colorectal Surgery (KEROS)

Duke University

Status: Terminated

Conditions: Goal-oriented Fluid Therapy; Colorectal Surgery

Treatments: Drug: Volulyte® (6% HES 130/0.4 in balanced solution); Other: Combined epidural-general anesthesia (CEGA); Other: Patient-Controlled Epidural Analgesia (PCEA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01874730

Pro00038567

Details and patient eligibility

About

This is a multi-centre study to take place in approximately 3 centers in Seoul, South Korea. The study will be carried out as a prospective, randomized, controlled, multicenter, clinical trial in patients undergoing colorectal surgery. The purpose of this study is to determine if an enhanced recovery strategy paying close attention to the type and amount of fluid given during the surgery with proper monitoring combined with a comprehensive perioperative pain management will have a better post-operative outcome compared to institutional standard of care (SOC), in patients undergoing surgery of the colon. One of the fluids used, Volulyte®, is an intravenous solution used to treat low blood volume. The Volulyte® solution being used in the study and the monitor used are approved by the Korean Food and Drug Administration

Enrollment: 101 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Elective, open colorectal surgery including sigmoid resections, i.e. with an upper rectal anastomosis and with or without planned stoma. If the planned surgery is a combined procedure, the associated procedure should not add more than 1 hour to the surgery time of the primary colorectal surgical procedure alone.
2. Both genders; age ≥ 45 years and ≤ 80 years.
3. ASA Grades I-III
4. Voluntary participation and signing the informed consent form

Exclusion criteria

1. Fluid overload (hyperhydration), especially in cases of pulmonary edema and congestive heart failure, or patients with severe cardiovascular disorders (New York Heart Association, NYHA III-IV)
2. Patients with significant cardiac arrhythmias or depending on pacemaker
3. Patients with impaired liver and/or kidney functions (ALT more than 2 times the normal upper limit and/or Serum Creatinine (SCr) more than 2 times the normal upper limit)
4. Renal failure with oliguria or anuria not related to hypovolemia
5. Patients receiving dialysis treatment
6. Patients with non-resectable malignancies
7. Patients who are non-cooperative or non-communicable
8. Patients with significant preoperative coagulation abnormalities
9. Patients receiving treatment with opioids for significant chronic pain
10. Patients in need of organ transplantation
11. Intracranial hemorrhage
12. Severe hypernatremia (Na+ > 155 mmol/l) or severe hyperchloremia (Cl- > 125 mmol/l)
13. Known hypersensitivity to hydroxyethyl starches
14. Participation in a clinical trial of an investigational drug or device within 30 days before study screening visit or is scheduled to receive an investigational product while participating in this study
15. Patients with evidenced bowel obstruction symptoms.
16. Contraindication to epidural anesthesia
17. Known pregnancy and lactation

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Standard of Care (SOC)

Other group

Description:

Intraoperative fluid management includes Volulyte® (6% hydroxyethyl starch {HES} 130/0.4 in balanced solution) as the only colloid solution to be used, the daily dosage of Volulyte® is restricted to 50 ml/kg. Intraoperative anesthesia and postoperative analgesia will follow the established practice of the individual institution.

Treatment:

Drug: Volulyte® (6% HES 130/0.4 in balanced solution)

Enhanced Recovery Strategy (ERS) group

Active Comparator group

Description:

GDFT regimen using Volulyte® (6% HES 130/0.4 in balanced solution) during surgery. The daily dosage of Volulyte® is restricted to 50 ml/kg. Combined epidural-general anesthesia (CEGA) will be used intraoperatively and patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen.

Treatment:

Other: Patient-Controlled Epidural Analgesia (PCEA)

Other: Combined epidural-general anesthesia (CEGA)

Drug: Volulyte® (6% HES 130/0.4 in balanced solution)