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ERAS Protocol on the Incidence of Postoperative Complications Following Intestinal Surgery

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ClinicalTrials.gov Identifier: NCT02728973
Recruitment Status : Unknown
Verified March 2016 by Min Su, First Affiliated Hospital of Chongqing Medical University.
Recruitment status was:  Recruiting
First Posted : April 6, 2016
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
Min Su, First Affiliated Hospital of Chongqing Medical University

Study Description
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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.

Condition or disease Intervention/treatment
Postoperative Complications Other: ERAS program

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effects of Enhanced Recovery After Surgery (ERAS) Protocol on the Incidence of Postoperative Complications Following Intestinal Surgery
Study Start Date : February 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 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.
conventional treatment program
conventional treatment


Outcome Measures
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Primary Outcome Measures :
  1. The difference in postoperative morbidity rate [ Time Frame: within postoperative 30 days ]

Secondary Outcome Measures :
  1. length of hospital stay [ Time Frame: within postoperative 30 days ]
  2. mortality [ Time Frame: within postoperative 30 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receive elective laparotomy or laparoscopic intestinal surgery
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728973


Contacts
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Contact: Juying Jin, doctor +89-13527486171 juyingjin@hotmail.com
Contact: Su Min, MD +86-89011068 ms89011068@163.com

Locations
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China
The first Affiliated Hospital of Chongqing Medical University Recruiting
Chongqing, China
Contact: Juying Jin, Doctor         
Sponsors and Collaborators
First Affiliated Hospital of Chongqing Medical University
Investigators
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Study Chair: Su Min, MD First Affiliated Hospital of Chongqing Medical University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Min Su, Professor, First Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT02728973    
Other Study ID Numbers: ERASCQ2016
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Min Su, First Affiliated Hospital of Chongqing Medical University:
colorectal resection
enhanced recovery after surgery
Postoperative Complications
length of hospital stay
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes