CholecystitisNCT05770128
Subserosal Laparoscopic Cholecystectomy
An observational study of Cholecystitis, run by Assiut University.
Trial summary
The aim is to study the safety and efficacy of subserosal laparoscopic cholecystectomy . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholecystitis
- What is being tested?
- laparoscope
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 Dec 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: any patient admitted to surgical department wth age above 18 years old suffering \& diagnosed of chronic cholecystitis , symptomatic cholelithiasis
Who may be able to join
- Adult with age of or above 18 years.
- Diagnosis of chronic cholecystitis , symptomatic cholelithiasis
Who cannot join
- Previous operation or adhesion
- severe Acute Calculus pancreatitis
- gall bladder cancer
- Severe co-morbid conditions (uncontrolled diabetes, Hypertension, severe direct hyper bilirubinemia)
- Recurrent cases
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Subserosal Laparoscopic Cholecystectomy for Safe Gall Bladder Surgery
The aim is to study the safety and efficacy of subserosal laparoscopic cholecystectomy .
- Conditions
- Cholecystitis
- Being tested
- laparoscope
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopeProcedure or surgery
subserosal manipulation of gallbladder with laparoscope .
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of safety of subserosal laparoscopic cholecystectomy in comparison to conventional technique.
incidence of bleeding after subserosal laparoscopic cholecystectomy in comparison to conventional technique.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 May 2023 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
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.
- More trials run by Assiut UniversityThe 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Hussein Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770128
- Sponsor's protocol ID
- cholecystectomy by laparoscpe
- Status last verified
- Mar 2023
- First submitted
- 25 Oct 2021
- Last updated
- 15 Mar 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 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subserosal Laparoscopic Cholecystectomy for Safe Gall Bladder Surgery
- ClinicalTrials.gov ID
- NCT05770128
- Acronym / sponsor ID
- cholecystectomy by laparoscpe
- Conditions
- Cholecystitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 15 Mar 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 is to study the safety and efficacy of subserosal laparoscopic cholecystectomy .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- any patient admitted to surgical department wth age above 18 years old suffering \& diagnosed of chronic cholecystitis , symptomatic cholelithiasis
Key inclusion criteria (2 listed)
- Adult with age of or above 18 years.
- Diagnosis of chronic cholecystitis , symptomatic cholelithiasis
Key exclusion criteria (5 listed)
- Previous operation or adhesion
- severe Acute Calculus pancreatitis
- gall bladder cancer
- Severe co-morbid conditions (uncontrolled diabetes, Hypertension, severe direct hyper bilirubinemia)
- Recurrent cases
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 |
|---|---|---|
| laparoscopesubserosal manipulation of gallbladder with laparoscope . | Procedure or surgery | – |
Primary outcome
Detection of safety of subserosal laparoscopic cholecystectomy in comparison to conventional technique.
Time frame: 6 months
incidence of bleeding after subserosal laparoscopic cholecystectomy in comparison to conventional technique.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystitis, run by Assiut University.
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 2 inclusion and 5 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 15 Mar 2023. 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 Ahmed M. Hussein, resident (+201010729020, ahmed.s7s1929@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of safety of subserosal laparoscopic cholecystectomy in comparison to conventional technique. (time frame: 6 months). 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 15 Mar 2023.