ERAS Protocol on the Incidence of Postoperative Complications Following Intestinal Surgery

NCT ID: NCT02728973

Last Updated: 2016-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-03-31

Brief 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.

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.

Conditions

Postoperative Complications

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

ERAS program

Intervention Type: OTHER

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

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Min Su

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Su Min, MD

Role: STUDY_CHAIR

First Affiliated Hospital of Chongqing Medical University

Locations

The first Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Juying Jin, doctor

Role: CONTACT

juyingjin@hotmail.com

+89-13527486171

Su Min, MD

Role: CONTACT

ms89011068@163.com

+86-89011068

Facility Contacts

Juying Jin, Doctor

Role: primary

References

Peng LH, Min S, Jin JY, Wang WJ. Stratified pain management counseling and implementation improving patient satisfaction: a prospective, pilot study. Chin Med J (Engl). 2019 Dec 5;132(23):2812-2819. doi: 10.1097/CM9.0000000000000540.

Reference Type: DERIVED

PMID: 31856052 (View on PubMed)

Other Identifiers

ERASCQ2016

Identifier Type: -

Identifier Source: org_study_id