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

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ClinicalTrials.gov Identifier: NCT03665987
Recruitment Status : Not yet recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Tracking Information
First Submitted Date September 1, 2018
First Posted Date September 11, 2018
Last Update Posted Date September 11, 2018
Estimated Study Start Date October 1, 2018
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2018)
length of stay [ Time Frame: an average of 5 days ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 8, 2018)
hospitalization expense [ Time Frame: an average of 5 days ]
The expense patients cost during hospitalization
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 8, 2018)
  • postoperative complication rate [ Time Frame: an average of 5 days ]
  • mortality rate [ Time Frame: an average of 5 days ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title The Effect of Preoperative Assessment Clinic on Prognosis and Economic Results of Patients With Coexisting Disease.
Official Title The Effect of Preoperative Assessment Clinic on Prognosis and Economic Results of Patients With Coexisting Diseases.
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Days
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The population will be selected from outpatient surgery department in Shanghai Zhongshan Hospital.
Condition
  • Length of Stay
  • Postoperative Complications
  • Morality
Intervention 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.
Study Groups/Cohorts
  • properative assessment clinic group
    The treatment group will be seen in the preoperative clinic before hospitalization.
    Intervention: Behavioral: consultation in preoperative assessment clinic
  • Control group
    The control group will get anesthetic consultation after hospitalization without clinic service.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: September 8, 2018)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2022
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Fang Fang, Doctor 86-13681972715 jerryfang81@hotmail.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03665987
Other Study ID Numbers B2018-112R
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
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.
Responsible Party Shanghai Zhongshan Hospital
Study Sponsor Shanghai Zhongshan Hospital
Collaborators Not Provided
Investigators
Study Chair: Jing Cang, Doctor Shanghai Zhongshan Hospital
PRS Account Shanghai Zhongshan Hospital
Verification Date September 2018