KOREAN Enhanced RecOvery Strategy for Colorectal Surgery

Study Overview
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Brief Summary
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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

Official Title
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KOREAN Enhanced RecOvery Strategy for Colorectal Surgery

Conditions
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Goal-oriented Fluid Therapy, Colorectal Surgery

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard of Care (SOC)<br>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)<br>* 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.<br>|
| Active Comparator: Enhanced Recovery Strategy (ERS) group<br>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. | Other: Combined epidural-general anesthesia (CEGA)<br>* Combined epidural-general anesthesia (CEGA) will be used intraoperatively and patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen.<br>Drug: Volulyte® (6% HES 130/0.4 in balanced solution)<br>* 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.<br>Other: Patient-Controlled Epidural Analgesia (PCEA)<br>* For the ERS Group, patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal surgery, fluid therapy