ERAS Protocol on the Incidence of Postoperative Complications Following Intestinal Surgery

Overview

Enhanced recovery after surgery (ERAS) was first proposed by Kehlet in Copenhagen Denmark, this is a new concept for the integration of the latest study of the surgical, anesthesia, and nursing. The purpose of optimization measures, reduce patient trauma stress, promote early rehabilitation of patients. The investigators plan to compare the feasibility, clinical effectiveness, and cost savings of an ERAS program with traditional treatment program at a major teaching hospital in China.The investigators will apply ERAS plan or traditional treatment regimens in the treatment of 100 cases of colorectal cancer patients, respectively. And data Compare the two programs about the incidence of postoperative complications, postoperative hospital stay, cost of hospitalization, and readmission rate will be collected.

Full Title of Study: “Effects of Enhanced Recovery After Surgery (ERAS) Protocol on the Incidence of Postoperative Complications Following Intestinal Surgery”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2016

Detailed Description

Major colorectal surgery usually requires a hospital stay of more than 12 days. Inadequate pain management, intestinal dysfunction and immobilisation are the main factors associated with delay in recovery. This study aims to assess the short and medium term results achieved by an enhanced recovery program based on previously published protocols. This prospective study will be performed at a major hospital in China, involved 200 patients. All patients underwent elective colorectal resection for cancer are divided into enhanced recovery program group or conventional treatment group. The main elements of this program were: preoperative advice, no colon preparation, provision of carbohydrate-rich drinks one day prior and on the morning of surgery, goal directed fluid administration, body temperature control during surgery, avoiding drainages and nasogastric tubes, early mobilization, and the taking of oral fluids in the early postoperative period. Perioperative morbidity and mortality data will be collected and the length of hospital stay and protocol compliance recorded.

Interventions

  • Other: ERAS program
    • The main elements of this program were: preoperative advice, no colon preparation, provision of carbohydrate-rich drinks one day prior and on the morning of surgery, goal directed fluid administration, body temperature control during surgery, avoiding drainages and nasogastric tubes, early mobilization, and the taking of oral fluids in the early postoperative period.

Arms, Groups and Cohorts

  • ERAS program
    • The main elements of this program were: preoperative advice, no colon preparation, provision of carbohydrate-rich drinks one day prior and on the morning of surgery, goal directed fluid administration, body temperature control during surgery, avoiding drainages and nasogastric tubes, early mobilization, and the taking of oral fluids in the early postoperative period.
  • conventional treatment program
    • conventional treatment

Clinical Trial Outcome Measures

Primary Measures

  • The difference in postoperative morbidity rate
    • Time Frame: within postoperative 30 days

Secondary Measures

  • length of hospital stay
    • Time Frame: within postoperative 30 days
  • mortality
    • Time Frame: within postoperative 30 days

Participating in This Clinical Trial

Inclusion Criteria

1. Elective laparotomy or laparoscopic intestinal surgery. 2. Age ≥ 18 years old. 3. ASA grade II – IV. 4. General anesthesia. Exclusion Criteria:

1. Patients with cognitive dysfunction and uncooperative subjects. 2. Failure to obtain informed consent

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • First Affiliated Hospital of Chongqing Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Min Su, Professor – First Affiliated Hospital of Chongqing Medical University
  • Overall Official(s)
    • Su Min, MD, Study Chair, First Affiliated Hospital of Chongqing Medical University
  • Overall Contact(s)
    • Juying Jin, doctor, +89-13527486171, juyingjin@hotmail.com

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