ERAS Protocol on the Incidence of Postoperative Complications Following Intestinal Surgery

Postoperative Complications Clinical Trial

Official title:

Effects of Enhanced Recovery After Surgery (ERAS) Protocol on the Incidence of Postoperative Complications Following Intestinal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02728973
• Other study ID #: ERASCQ2016
• Status: Recruiting
• Phase: N/A
• First received: March 27, 2016
• Last updated: March 31, 2016
• Start date: February 2016
• Est. completion date: March 2017

Study information

• Verified date: March 2016
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: Juying Jin, doctor
• Phone: +89-13527486171
• Email: juyingjin[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

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.

Locations

Country	Name	City	State
China	The first Affiliated Hospital of Chongqing Medical University	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in postoperative morbidity rate		within postoperative 30 days	No
Secondary	length of hospital stay		within postoperative 30 days	No
Secondary	mortality		within postoperative 30 days	No