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KOREAN Enhanced RecOvery Strategy for Colorectal Surgery

45 Years
80 Years
Not Enrolling
Goal-oriented Fluid Therapy, Colorectal Surgery

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Trial Information

KOREAN Enhanced RecOvery Strategy for Colorectal Surgery

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

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

15. an investigational product while participating in this study Patients with evidenced
bowel obstruction symptoms.

16. Contraindication to epidural anesthesia

17. Known pregnancy and lactation

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Postoperative Outcome

Outcome Description:

Postoperative outcome is defined as the number of patients who develop at least one postoperative complication during their hospital stay

Outcome Time Frame:

From Day 1 after surgery and duration of hospital stay (approximately 6 days after surgery)

Safety Issue:


Principal Investigator

Tong J Gan, MD, MHS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


Korea: Food and Drug Administration

Study ID:




Start Date:

July 2013

Completion Date:

May 2014

Related Keywords:

  • Goal-oriented Fluid Therapy
  • Colorectal Surgery
  • colorectal surgery
  • fluid therapy