Length of StayNCT03665987
The Effect of Preoperative Assessment Clinic on Prognosis and Economic Results of Patients With Coexisting Disease.
An observational study of Length of Stay and Postoperative Complications, run by Shanghai Zhongshan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Length of Stay, Postoperative Complications, Morality
- What is being tested?
- consultation in preoperative assessment clinic
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 30 Jun 2022
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will be selected from outpatient surgery department in Shanghai Zhongshan Hospital.
Who may be able to join
- 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
Who cannot join
- patients ubdergoing emergency operation
- ASA I, IV
- patients under 60 years old
- patients with bad compliance
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Length of Stay, Postoperative Complications, Morality
- Being tested
- consultation in preoperative assessment clinic
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
consultation in preoperative assessment clinicBehavioural
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 group | Role | What they receive |
|---|---|---|
| properative assessment clinic group | The treatment group will be seen in the preoperative clinic before hospitalization. Receives: Behavioral: consultation in preoperative assessment clinic | |
| Control group | The control group will get anesthetic consultation after hospitalization without clinic service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of stay
Measured: an average of 5 days
Secondary outcomes (1)
hospitalization expense
The expense patients cost during hospitalization
Measured: an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Oct 2018 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Length of StayStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Cang, Doctor, Study chair, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665987
- Sponsor's protocol ID
- B2018-112R
- Status last verified
- Sep 2018
- First submitted
- 1 Sep 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 11867390Ferschl 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.
PubMed 16192779
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Assessment Clinic on Prognosis and Economic Results of Patients With Coexisting Diseases.
- ClinicalTrials.gov ID
- NCT03665987
- Acronym / sponsor ID
- B2018-112R
- Conditions
- Length of Stay, Postoperative Complications, Morality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| properative assessment clinic group | – | Behavioral: consultation in preoperative assessment clinicThe treatment group will be seen in the preoperative clinic before hospitalization. |
| Control group | – | –The control group will get anesthetic consultation after hospitalization without clinic service. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be selected from outpatient surgery department in Shanghai Zhongshan Hospital.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- patients ubdergoing emergency operation
- ASA I, IV
- patients under 60 years old
- patients with bad compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| consultation in preoperative assessment clinicThe 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. | Behavioural | properative assessment clinic group |
Primary outcome
length of stay
Time frame: an average of 5 days
1 secondary outcome
hospitalization expense
Time frame: an average of 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Results publication: PubMed 11867390van 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.
- Results publication: PubMed 16192779Ferschl 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.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Length of Stay
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
RecruitingPhase 3
A Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery.
Coronary Artery Disease (CAD), Coronary Artery Bypass Graft Surgery(CABG)
Not yet recruitingPhase 2
Intravenous Ketamine for Acute Suicidal Crisis and Psychiatric Hospital Length of Stay
Suicidal Ideation, Suicidal Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Cang, Doctor study chair
Shanghai Zhongshan Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Length of Stay and Postoperative Complications, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang Fang, Doctor (86-13681972715, jerryfang81@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of stay (time frame: an average of 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03665987, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.