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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

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.

Condition or disease Intervention/treatment
Length of Stay Postoperative Complications Morality Behavioral: consultation in preoperative assessment clinic

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Days
Official Title: The Effect of Preoperative Assessment Clinic on Prognosis and Economic Results of Patients With Coexisting Diseases.
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. length of stay [ Time Frame: an average of 5 days ]

Secondary Outcome Measures :
  1. hospitalization expense [ Time Frame: an average of 5 days ]
    The expense patients cost during hospitalization


Other Outcome Measures:
  1. postoperative complication rate [ Time Frame: an average of 5 days ]
  2. mortality rate [ Time Frame: an average of 5 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The population will be selected from outpatient surgery department in Shanghai Zhongshan Hospital.
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

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): NCT03665987


Contacts
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Contact: Fang Fang, Doctor 86-13681972715 jerryfang81@hotmail.com

Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Study Chair: Jing Cang, Doctor Shanghai Zhongshan Hospital

Additional Information:

Publications of Results:
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03665987     History of Changes
Other Study ID Numbers: B2018-112R
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes