KOREAN Enhanced RecOvery Strategy for Colorectal Surgery (KEROS)

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

Study Overview

• Status: Terminated
• Conditions: Colorectal Surgery; Goal-oriented Fluid Therapy
• Intervention / Treatment: 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
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul
    • Gangnam-Gu, Seoul, Korea, Republic of, 135-710
      • Samsung Medical Center
    • Seodaemun-gu, Seoul, Korea, Republic of
      • Yonsei University College of Medicine
    • Songpa-gu, Seoul, Korea, Republic of, 138-736
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard of Care (SOC); 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.	Drug: Volulyte® (6% HES 130/0.4 in balanced solution); For the SOC Group: Intraoperative fluid management includes Volulyte® (6% 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. For the ERS Group: GDFT regimen will be utilized using Volulyte® (6% HES 130/0.4 in balanced solution) during surgery. The daily dosage of Volulyte® is restricted to 50 ml/kg.
Active Comparator: Enhanced Recovery Strategy (ERS) group; 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.	Drug: Volulyte® (6% HES 130/0.4 in balanced solution); For the SOC Group: Intraoperative fluid management includes Volulyte® (6% 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. For the ERS Group: GDFT regimen will be utilized using Volulyte® (6% HES 130/0.4 in balanced solution) during surgery. The daily dosage of Volulyte® is restricted to 50 ml/kg.; Other: Combined epidural-general anesthesia (CEGA); Combined epidural-general anesthesia (CEGA) will be used intraoperatively and patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen.; Other: Patient-Controlled Epidural Analgesia (PCEA); For the ERS Group, patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Outcome	Postoperative outcome is defined as the number of patients who develop at least one postoperative complication during their hospital stay	From Day 1 after surgery and duration of hospital stay (approximately 6 days after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative outcome for each patient at postoperative day (POD) 30	Postoperative outcome for each patient at postoperative day (POD) 30 is defined as whether the patient encountered at least one postoperative complication up to POD 30	From Hospital Discharge (approximately 6 days after surgery), up to 4 weeks after day of surgery
Number of postoperative complications per group	Number of postoperative complications per group evaluated postoperatively from date of surgery, each hospital day, (post-operative days 1 through 5), at discharge from the hospital until 30 days from day of surgery.	Participants will be followed for the duration of hospital stay (approximately 6 days after surgery), and until 4 weeks from day of surgery
Time to "clinically fit for discharge from hospital"	Time to "clinically fit for discharge from hospital" when defined discharge criteria are met (evaluation starts from POD 4 at 10 am each day till discharge).	From 4 days after surgery to Hospital discharge (approximately 6 days after surgery)
Change in Postoperative pain	Postoperative pain at 1h, 2 h, 6 h, 24 h, and post-operative days 1 through 5, and at discharge (evaluated with a verbal rating scale (VRS), 0 = no pain, 10 = worst possible pain) until discharge. Pain assessment is performed at rest and during activity (cough).	1h, 2 h, 6 h, 24 h post-surgery, and post-operative days 1 through 5, and at discharge
change in incidence of nausea and vomiting	The incidence of nausea and vomiting at 1h, 2 h, 24 h, and post-operative days 2 through 5, and at discharge from the hospital.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of first bowel movement		After surgery until occurence of first bowel movement during hospital stay (approximately 6 days after surgery)
Time to tolerating liquid intake		After surgery until subject is able to tolerate oral fluids during hospital stay(approximately 6 days after surgery)
Time to tolerating solid intake.		After surgery until subject is able to tolerate solid oral intake during hospital stay (approximately 6 days after surgery)
Postoperative recovery score (QoR-15)	Recovery Scores will be taken at hospital stay (POD 1 to POD 5, Hospital Discharge) and will be repeated at POD 30	For duration of hospital stay (approximately 6 days after surgery), and 4 weeks after the surgery
6 min Walk Test	If tolerated, individual walks without physical assistance for 6 minutes and the distance is measured. this test will be done at hospital stay (POD 1 to POD 5, Hospital Discharge) and will be repeated at POD 30	For duration of hospital stay (approximately 6 days after surgery), and 4 weeks after the surgery

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Tong J Gan, MD, MHS, Duke University; Principal Investigator: Yang-Sik Shin, MD, Shinchon Severance Hospital; Principal Investigator: Duk-Kyung Kim, MD PhD, Samsung Medical Center; Principal Investigator: Gyu-Jeong Noh, MD PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: June 4, 2013
• First Submitted That Met QC Criteria: June 7, 2013
• First Posted (Estimate): June 11, 2013

Study Record Updates

• Last Update Posted (Estimate): August 7, 2015
• Last Update Submitted That Met QC Criteria: August 5, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: colorectal surgery; fluid therapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: Pro00038567