KOREAN Enhanced RecOvery Strategy for Colorectal Surgery

NCT01874730 | Terminated

• 1 other identifier: Pro00038567
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 3

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

Keywords

colorectal surgery; fluid therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• Time to "clinically fit for discharge from hospital"

  From 4 days after surgery to Hospital discharge (approximately 6 days after surgery)

• Change in Postoperative pain

  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

  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 (5)

• 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)

Study Arms (2)

Standard of Care (SOC)

OTHER

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)

Enhanced Recovery Strategy (ERS) group

ACTIVE COMPARATOR

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); Drug: Volulyte® (6% HES 130/0.4 in balanced solution); Other: Patient-Controlled Epidural Analgesia (PCEA)

Interventions

Combined epidural-general anesthesia (CEGA) 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.

Enhanced Recovery Strategy (ERS) group

Volulyte® (6% HES 130/0.4 in balanced solution) 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; Standard of Care (SOC)

Patient-Controlled Epidural Analgesia (PCEA) OTHER

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

Enhanced Recovery Strategy (ERS) group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (3)

Samsung Medical Center

Gangnam-Gu, Seoul, 135-710, South Korea

Location

Yonsei University College of Medicine

Seodaemun-gu, Seoul, South Korea

Location

Asan Medical Center

Songpa-gu, Seoul, 138-736, South Korea

Location

MeSH Terms

Interventions

Hydroxyethyl Starch Derivatives

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 11, 2013
• Study Start: July 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 7, 2015

Record last verified: 2015-08

Locations

KR (3)