KOREAN Enhanced RecOvery Strategy for Colorectal Surgery

NCT ID: NCT01874730

Last Updated: 2015-08-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-06-30

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

Conditions

Goal-oriented Fluid Therapy; Colorectal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Volulyte® (6% HES 130/0.4 in balanced solution)

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Combined epidural-general anesthesia (CEGA)

Intervention Type: OTHER

Combined epidural-general anesthesia (CEGA) will be used intraoperatively and patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen.

Volulyte® (6% HES 130/0.4 in balanced solution)

Intervention Type: DRUG

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.

Patient-Controlled Epidural Analgesia (PCEA)

Intervention Type: OTHER

For the ERS Group, patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DRUG

Patient-Controlled Epidural Analgesia (PCEA)

For the ERS Group, patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen.

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tong J Gan, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Duke University

Yang-Sik Shin, MD

Role: PRINCIPAL_INVESTIGATOR

Shinchon Severance Hospital

Duk-Kyung Kim, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Gyu-Jeong Noh, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Samsung Medical Center

Gangnam-Gu, Seoul, South Korea

Yonsei University College of Medicine

Seodaemun-gu, Seoul, South Korea

Asan Medical Center

Songpa-gu, Seoul, South Korea

Countries

South Korea

Other Identifiers

Pro00038567

Identifier Type: -

Identifier Source: org_study_id