KOREAN Enhanced RecOvery Strategy for Colorectal Surgery

Not Applicable

Terminated

• Conditions: Goal-oriented Fluid Therapy; Colorectal Surgery
• Interventions: Drug: Volulyte® (6% HES 130/0.4 in balanced solution); Other: Combined epidural-general anesthesia (CEGA); Other: Patient-Controlled Epidural Analgesia (PCEA)

• Registration Number: NCT01874730
• Lead Sponsor: Duke University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-11
• Study Start: 2013-07
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-05
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 101

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care (SOC)	Volulyte® (6% HES 130/0.4 in balanced solution)	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.
Enhanced Recovery Strategy (ERS) group	Combined epidural-general anesthesia (CEGA)	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.
Enhanced Recovery Strategy (ERS) group	Volulyte® (6% HES 130/0.4 in balanced solution)	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.
Enhanced Recovery Strategy (ERS) group	Patient-Controlled Epidural Analgesia (PCEA)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of postoperative complications per group	Participants will be followed for the duration of hospital stay (approximately 6 days after surgery), and until 4 weeks from day of surgery	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.
Change in Postoperative pain	1h, 2 h, 6 h, 24 h post-surgery, and post-operative days 1 through 5, and at discharge	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).
change in incidence of nausea and vomiting	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)	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.
Postoperative outcome for each patient at postoperative day (POD) 30	From Hospital Discharge (approximately 6 days after surgery), up to 4 weeks after day of surgery	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
Time to "clinically fit for discharge from hospital"	From 4 days after surgery to Hospital discharge (approximately 6 days after surgery)	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).

Trial Locations

Locations (3)

Samsung Medical Center; 🇰🇷 Gangnam-Gu, Seoul, Korea, Republic of

Yonsei University College of Medicine; 🇰🇷 Seodaemun-gu, Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Songpa-gu, Seoul, Korea, Republic of