Status:
TERMINATED
KOREAN Enhanced RecOvery Strategy for Colorectal Surgery
Lead Sponsor:
Duke University
Conditions:
Goal-oriented Fluid Therapy
Colorectal Surgery
Eligibility:
All Genders
45-80 years
Phase:
NA
Brief Summary
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 pati...
Eligibility Criteria
Inclusion
- 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.
- Both genders; age ≥ 45 years and ≤ 80 years.
- ASA Grades I-III
- Voluntary participation and signing the informed consent form
Exclusion
- 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)
- Patients with significant cardiac arrhythmias or depending on pacemaker
- 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)
- Renal failure with oliguria or anuria not related to hypovolemia
- Patients receiving dialysis treatment
- Patients with non-resectable malignancies
- Patients who are non-cooperative or non-communicable
- Patients with significant preoperative coagulation abnormalities
- Patients receiving treatment with opioids for significant chronic pain
- Patients in need of organ transplantation
- Intracranial hemorrhage
- Severe hypernatremia (Na+ \> 155 mmol/l) or severe hyperchloremia (Cl- \> 125 mmol/l)
- Known hypersensitivity to hydroxyethyl starches
- 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
- Patients with evidenced bowel obstruction symptoms.
- Contraindication to epidural anesthesia
- Known pregnancy and lactation
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01874730
Start Date
July 1 2013
End Date
June 1 2015
Last Update
August 7 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Samsung Medical Center
Gangnam-Gu, Seoul, South Korea, 135-710
2
Yonsei University College of Medicine
Seodaemun-gu, Seoul, South Korea
3
Asan Medical Center
Songpa-gu, Seoul, South Korea, 138-736