The Effect of Preoperative Assessment Clinic on Prognosis and Economic Results of Patients With Coexisting Disease.

The Effect of Preoperative Assessment Clinic on Prognosis and Economic Results of Patients With Coexisting Diseases.

To assess the effect of preoperative assessment clinic on prognosis and economic results of patients with coexisting diseases, the investigators designed a prospective cohort study. The investigators will recruit 250 patients preparing to undergo a selective epigastrium surgery with coexisting medical diseases which need an anesthetic consultation. The patients will be randomly assigned into two groups. The intervention group will be seen in the preoperative clinic before hospitalization, while the control group will get anesthetic consultation after hospitalization without clinic service. No additional interventions will be given during and after surgery. The length of stay, hospitalization expense, postoperative complication rate and mortality rate of the two groups will be compared. The investigator assume that consultation in preoperative assessment clinic will improve the prognosis and decrease the hospitalization expenses.

Study Overview

• Status: Unknown
• Conditions: Postoperative Complications; Morality; Length of Stay
• Intervention / Treatment: Behavioral: consultation in preoperative assessment clinic

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The population will be selected from outpatient surgery department in Shanghai Zhongshan Hospital.

Description

Inclusion Criteria:

• patients preparing to undergo a selective epigastrium surgery
• patients with coexisting medical diseases needing an anesthetic consultation
• over 60 years old
• ASA II-III
• patients with good compliance

Exclusion Criteria:

• patients ubdergoing emergency operation
• ASA I, IV
• patients under 60 years old
• patients with bad compliance

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
properative assessment clinic group; The treatment group will be seen in the preoperative clinic before hospitalization.	Behavioral: consultation in preoperative assessment clinic; The treatment group will be seen in the preoperative clinic before hospitalization, while the control group will get anesthetic consultation after hospitalization without clinic service. No additional interventions will be given during and after surgery.
Control group; The control group will get anesthetic consultation after hospitalization without clinic service.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
length of stay	an average of 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospitalization expense	The expense patients cost during hospitalization	an average of 5 days

Other Outcome Measures

Outcome Measure	Time Frame
postoperative complication rate	an average of 5 days
mortality rate	an average of 5 days

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Study Chair: Jing Cang, Doctor, Shanghai Zhongshan Hospital

Publications and helpful links

General Publications

• van Klei WA, Moons KG, Rutten CL, Schuurhuis A, Knape JT, Kalkman CJ, Grobbee DE. The effect of outpatient preoperative evaluation of hospital inpatients on cancellation of surgery and length of hospital stay. Anesth Analg. 2002 Mar;94(3):644-9; table of contents. doi: 10.1097/00000539-200203000-00030.
• Ferschl MB, Tung A, Sweitzer B, Huo D, Glick DB. Preoperative clinic visits reduce operating room cancellations and delays. Anesthesiology. 2005 Oct;103(4):855-9. doi: 10.1097/00000542-200510000-00025.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2018
• Primary Completion (ANTICIPATED): January 31, 2022
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: September 1, 2018
• First Submitted That Met QC Criteria: September 8, 2018
• First Posted (ACTUAL): September 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 8, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: B2018-112R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The participants haven't recruited yet and we have no idea about sharing IPD to other reearchers. Maybe we will share the clinical study report to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No