Length of Hospital StayNCT05851833
A Retrospective Study of Early Postoperative Mobilization in the Recovery of Patients With Oral Head and Neck Tumors Who Underwent Flap Reconstruction
An observational study of Length of Hospital Stay, run by Jie He, MD at 1 site in China.
Trial summary
All patients with head and neck cancers and osteomyelitis who underwent vascularized flap reconstruction at Shanghai Ninth People's Hospital (North Campus), Shanghai Jiao Tong University, from February 2020 to July 2021 were the object of a retrospective data collection.Depending on whether they had postoperative… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Length of Hospital Stay
- What is being tested?
- Early Mobilization
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 244 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 1 Aug 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Early Mobilizationon Recovery After Major Head and Neck Surgery With Flap Reconstruction
Who may be able to join
- Patients with head and neck diseases undergoing flap reconstruction and repair
- Patients with complete data preservation and consent
- Patients who follow medical advice during hospitalization
Who cannot join
- Patients who survived less than 1 month after surgery
- Patients with other tumors before surgery 3, mental patients, audio-visual impairment or uncooperative patients
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, 200000
About this study
All patients with head and neck cancers and osteomyelitis who underwent vascularized flap reconstruction at Shanghai Ninth People's Hospital (North Campus), Shanghai Jiao Tong University, from February 2020 to July 2021 were the object of a retrospective data collection.Depending on whether they had postoperative early mobilization, all patients were split into experimental and control groups.In the experimental group, patients were split into two groups based on the postoperative day(POD): the POD 0-1 group and the POD >1 group.Comparison and analysis were done on the difference in hospital days and post-operative complication rates between the two groups.
- Conditions
- Length of Hospital Stay
- Being tested
- Early Mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early MobilizationBehavioural
The time the patient began to sit, stand, and walk after surgery is earlier than traditional model.
| Study group | Role | What they receive |
|---|---|---|
| Early MobilizatioN | Not described Receives: Behavioral: Early Mobilization | |
| conventional Mobilization | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay after surgery
The time span between the end of surgery and hospital discharge is defined as the length of hospital stay after surgery.
Measured: February 2020 to July 2021
Secondary outcomes (3)
pulmonary infection rate
The pulmonary infection rate is calculated as the proportion of hospitalized patients who had pulmonary infections over all patients.
Measured: February 2020 to July 2021
deep vein thrombosis rate
The deep vein thrombosis rate is calculated as the proportion of hospitalized patients who had deep vein thrombosis over all patients.
Measured: February 2020 to July 2021
flap crisis rate
The flap crisis rate is calculated as the proportion of hospitalized patients who had flap crisis over all patients.
Measured: February 2020 to July 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Mar 2020
- Primary completion31 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Length of Hospital StayStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jie He, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jie He, MD, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851833
- Sponsor's protocol ID
- 654321
- Status last verified
- May 2023
- First submitted
- 1 May 2023
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Early Postoperative Mobilization in the Recovery of Patients With Oral Head and Neck Tumors Who Underwent Flap Reconstruction
- ClinicalTrials.gov ID
- NCT05851833
- Acronym / sponsor ID
- 654321
- Conditions
- Length of Hospital Stay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Jie He, MDUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 10 May 2023 (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.
All patients with head and neck cancers and osteomyelitis who underwent vascularized flap reconstruction at Shanghai Ninth People's Hospital (North Campus), Shanghai Jiao Tong University, from February 2020 to July 2021 were the object of a retrospective data collection.Depending on whether they had postoperative early mobilization, all patients were split into experimental and control groups.In the experimental group, patients were split into two groups based on the postoperative day(POD): the POD 0-1 group and the POD >1 group.Comparison and analysis were done on the difference in hospital days and post-operative complication rates between the two groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early MobilizatioN | – | Behavioral: Early Mobilization |
| conventional Mobilization | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Early Mobilizationon Recovery After Major Head and Neck Surgery With Flap Reconstruction
Key inclusion criteria (3 listed)
- Patients with head and neck diseases undergoing flap reconstruction and repair
- Patients with complete data preservation and consent
- Patients who follow medical advice during hospitalization
Key exclusion criteria (2 listed)
- Patients who survived less than 1 month after surgery
- Patients with other tumors before surgery 3, mental patients, audio-visual impairment or uncooperative patients
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 |
|---|---|---|
| Early MobilizationThe time the patient began to sit, stand, and walk after surgery is earlier than traditional model. | Behavioural | Early MobilizatioN |
Primary outcome
Length of hospital stay after surgery
Time frame: February 2020 to July 2021
The time span between the end of surgery and hospital discharge is defined as the length of hospital stay after surgery.
3 secondary outcomes
pulmonary infection rate
Time frame: February 2020 to July 2021
deep vein thrombosis rate
Time frame: February 2020 to July 2021
flap crisis rate
Time frame: February 2020 to July 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Length of Hospital Stay, run by Jie He, MD at 1 site in China.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay after surgery (time frame: February 2020 to July 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2023.