Clinical trial NCT01874730: KOREAN Enhanced RecOvery Strategy for Colorectal Surgery
Official title: KOREAN Enhanced RecOvery Strategy for Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Goal-oriented Fluid Therapy
Colorectal Surgery
Keywords: colorectal surgery
fluid therapy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 101
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Outcome
timeFrame: From Day 1 after surgery and duration of hospital stay (approximately 6 days after surgery)
Secondary outcomes:
measure: Postoperative outcome for each patient at postoperative day (POD) 30
timeFrame: From Hospital Discharge (approximately 6 days after surgery), up to 4 weeks after day of surgery
measure: Number of postoperative complications per group
timeFrame: Participants will be followed for the duration of hospital stay (approximately 6 days after surgery), and until 4 weeks from day of surgery
measure: Time to "clinically fit for discharge from hospital"
timeFrame: From 4 days after surgery to Hospital discharge (approximately 6 days after surgery)
measure: Change in Postoperative pain
timeFrame: 1h, 2 h, 6 h, 24 h post-surgery, and post-operative days 1 through 5, and at discharge
measure: change in incidence of nausea and vomiting
timeFrame: 1h, 2 h, 24 h post-surgery, and post-operative days 2 through 5, and at discharge from the hospital (approximately 6 days after surgery)
Other outcomes:
measure: Time of first bowel movement
timeFrame: After surgery until occurence of first bowel movement during hospital stay (approximately 6 days after surgery)
measure: Time to tolerating liquid intake
timeFrame: After surgery until subject is able to tolerate oral fluids during hospital stay(approximately 6 days after surgery)
measure: Time to tolerating solid intake.
timeFrame: After surgery until subject is able to tolerate solid oral intake during hospital stay (approximately 6 days after surgery)
measure: Postoperative recovery score (QoR-15)
timeFrame: For duration of hospital stay (approximately 6 days after surgery), and 4 weeks after the surgery
measure: 6 min Walk Test
timeFrame: For duration of hospital stay (approximately 6 days after surgery), and 4 weeks after the surgery
Locations:
city: Gangnam-Gu
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul
city: Seodaemun-gu
country: Korea, Republic of
facility: Yonsei University College of Medicine
state: Seoul
city: Songpa-gu
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul
Study officials:
affiliation: Duke University
name: Tong J Gan, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: Shinchon Severance Hospital
name: Yang-Sik Shin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Duk-Kyung Kim, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Gyu-Jeong Noh, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: