KOREAN Enhanced RecOvery Strategy for Colorectal Surgery

Colorectal Surgery Clinical Trial

— KEROS  

Official title:

KOREAN Enhanced RecOvery Strategy for Colorectal Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01874730
• Other study ID #: Pro00038567
• Status: Terminated
• Phase: N/A
• First received: June 4, 2013
• Last updated: August 5, 2015
• Start date: July 2013
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug AdministrationKorea: Institutional Review BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 101
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Surgery
• Goal-oriented Fluid Therapy

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time of first bowel movement		After surgery until occurence of first bowel movement during hospital stay (approximately 6 days after surgery)	No
Other	Time to tolerating liquid intake		After surgery until subject is able to tolerate oral fluids during hospital stay(approximately 6 days after surgery)	No
Other	Time to tolerating solid intake.		After surgery until subject is able to tolerate solid oral intake during hospital stay (approximately 6 days after surgery)	No
Other	Postoperative recovery score (QoR-15)	Recovery Scores will be taken at hospital stay (POD 1 to POD 5, Hospital Discharge) and will be repeated at POD 30	For duration of hospital stay (approximately 6 days after surgery), and 4 weeks after the surgery	No
Other	6 min Walk Test	If tolerated, individual walks without physical assistance for 6 minutes and the distance is measured. this test will be done at hospital stay (POD 1 to POD 5, Hospital Discharge) and will be repeated at POD 30	For duration of hospital stay (approximately 6 days after surgery), and 4 weeks after the surgery	No
Primary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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	No
Secondary	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)	No