KOREAN Enhanced RecOvery Strategy for Colorectal Surgery

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

Interventions

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.

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

Patient-Controlled Epidural Analgesia (PCEA)

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

Sponsors & Collaborators

• Duke University

  lead OTHER

Principal Investigators

• Tong J Gan, MD, MHS · Duke University

• Yang-Sik Shin, MD · Shinchon Severance Hospital

• Duk-Kyung Kim, MD PhD · Samsung Medical Center

• Gyu-Jeong Noh, MD PhD · Asan Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-07-31

Primary Completion

2015-06-30

Completion

2015-06-30

Countries

• South Korea