CholecystitisNCT06086977
Pulse Analysis for Cholecystitis Patients Before and After Cholecystectomy
An observational study of Cholecystitis and Cholecystectomy, run by Taichung Tzu Chi Hospital at 1 site in Taiwan.
Trial summary
The aim of this study is to record the radial pressure pulse(RPP) of the patients with cholecystitis compared preoperative and postoperative pulse changes in an attempt to determine the relationship between cholecystitis and pulse. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cholecystitis, Cholecystectomy
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Apr 2021to 12 Jun 2022
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cholecystitis and recieve cholecystectomy
Who may be able to join
- Patients diagnosed with acute or chronic cholecystitis
- Patient hospitalized for cholecystectomy
- Patients who were voluntarily involved in this study
Who cannot join
- Patients who could not cooperate with pulse diagnosis
- Patients with underlying systemic diseases such as cancer, chronic obstructive pulmonary disease, cardiac failure, chronic renal failure, cirrhosis, etc.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to record the radial pressure pulse(RPP) of the patients with cholecystitis compared preoperative and postoperative pulse changes in an attempt to determine the relationship between cholecystitis and pulse.
Read the detailed description
A total of 20 patients were recruited according to the inclusion and exclusion criteria. The patients, aged 32-76 years, were given a diagnosis of cholecystitis by a general surgeon from Taiwan's Taichung Tzu Chi Hospital. All eligible patients included in the study agreed to participated and signed the informed consent form and the study procedures were approved by the ethical committee of Taichung Tzu Chi general hospital (REC110-12). By measuring and recording the RPP preoperatively and postoperatively, the mean values of the spectral energy (SE0-10 Hz, SE10-50 Hz, and SE13-50 Hz) were obtained for comparison with the preoperative white blood cell (WBC) count.
- Conditions
- Cholecystitis, Cholecystectomy
- Keywords
- radial pressure pulse (RPP)
- Medical subject headings
- Cholecystitis
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of spectral energy of radial artery pulse after cholecystectomy
The spectral energy of radial artery pulse was measured before and after cholecystectomy to compare the difference
Measured: Baseline (before cholecystectomy) and 24 -48 hours after cholecystectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start8 Apr 2021
- Primary completion12 Feb 2022
- Study completion12 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies 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
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Tzu Chi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, I-Hsuan Chien, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086977
- Sponsor's protocol ID
- REC110-12
- Status last verified
- Oct 2023
- First submitted
- 22 Sep 2022
- Last updated
- 17 Oct 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 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Analysis for Cholecystitis Patients Before and After Cholecystectomy
- ClinicalTrials.gov ID
- NCT06086977
- Acronym / sponsor ID
- REC110-12
- Conditions
- Cholecystitis, Cholecystectomy
- Keywords
- radial pressure pulse (RPP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Taichung Tzu Chi HospitalUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 12 Feb 2022 (actual)
- Study completion
- 12 Jun 2022 (actual)
- First posted
- 17 Oct 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.
The aim of this study is to record the radial pressure pulse(RPP) of the patients with cholecystitis compared preoperative and postoperative pulse changes in an attempt to determine the relationship between cholecystitis and pulse.
Detailed description
A total of 20 patients were recruited according to the inclusion and exclusion criteria. The patients, aged 32-76 years, were given a diagnosis of cholecystitis by a general surgeon from Taiwan's Taichung Tzu Chi Hospital. All eligible patients included in the study agreed to participated and signed the informed consent form and the study procedures were approved by the ethical committee of Taichung Tzu Chi general hospital (REC110-12). By measuring and recording the RPP preoperatively and postoperatively, the mean values of the spectral energy (SE0-10 Hz, SE10-50 Hz, and SE13-50 Hz) were obtained for comparison with the preoperative white blood cell (WBC) count.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cholecystitis and recieve cholecystectomy
Key inclusion criteria (3 listed)
- Patients diagnosed with acute or chronic cholecystitis
- Patient hospitalized for cholecystectomy
- Patients who were voluntarily involved in this study
Key exclusion criteria (2 listed)
- Patients who could not cooperate with pulse diagnosis
- Patients with underlying systemic diseases such as cancer, chronic obstructive pulmonary disease, cardiac failure, chronic renal failure, cirrhosis, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The changes of spectral energy of radial artery pulse after cholecystectomy
Time frame: Baseline (before cholecystectomy) and 24 -48 hours after cholecystectomy
The spectral energy of radial artery pulse was measured before and after cholecystectomy to compare the difference
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 17 Oct 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 Cholecystitis and Cholecystectomy, run by Taichung Tzu Chi Hospital at 1 site in Taiwan.
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 17 Oct 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 Taiwan. 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?
The changes of spectral energy of radial artery pulse after cholecystectomy (time frame: Baseline (before cholecystectomy) and 24 -48 hours after cholecystectomy). 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 17 Oct 2023.