Clinical trial NCT02728973: ERAS Protocol on the Incidence of Postoperative Complications Following Intestinal Surgery
Official title: Effects of Enhanced Recovery After Surgery (ERAS) Protocol on the Incidence of Postoperative Complications Following Intestinal Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Complications
Keywords: colorectal resection
enhanced recovery after surgery
Postoperative Complications
length of hospital stay
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receive elective laparotomy or laparoscopic intestinal surgery

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.

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

Primary outcomes:
measure: The difference in postoperative morbidity rate
timeFrame: within postoperative 30 days
Secondary outcomes:
measure: length of hospital stay
timeFrame: within postoperative 30 days
measure: mortality
timeFrame: within postoperative 30 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The first Affiliated Hospital of Chongqing Medical University
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Su Min, MD
role: STUDY_CHAIR
References:
citation: 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.