Cholecystitis; GallstoneNCT04041726
Intraoperative Spillage of Bile and Gallstones During Laparoscopic Cholecysetectomy
An observational study of Cholecystitis; Gallstone, run by Assiut University.
Trial summary
1. determine the most important factors which is responsible for the outcome post bile and gallstones spillage during laparoscopic cholecystectomy 2. the management of complications of bile and gallstones spillage Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholecystitis; Gallstone
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 1 Oct 2020
- 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
- Child, Adult, Older adult
Study population: Results from intraoperative spillage of bile and gallstones intra abdomen during laparascopic cholecystectomy
Who may be able to join
- all age groups
- only laparoscopic cholecystectomy
- all types ,numbers and sizes os gall stones
Who cannot join
- open cholecystectomh
- patient refuse to enrol this study
Trial locations and contacts
No sites are listed yet.
About this study
- determine the most important factors which is responsible for the outcome post bile and gallstones spillage during laparoscopic cholecystectomy
- the management of complications of bile and gallstones spillage
Read the detailed description
Laparoscopic cholecystectomy is preferred surgical treatment for symptomatic gallstones .laparscopic procedure is superior to open procedue .the incidence of gallbladder perforation and spillage of bile and gallstones has been found as high as 40% .complications and management of gall bladder perforation and spillage of gallstones and bile
- Conditions
- Cholecystitis; Gallstone
- Medical subject headings
- Cholecystitis, Gallstones
What is being measured
The primary outcome is the main question the study is designed to answer.
Our purpose was to report the occurrence of complications following spilled gallstones during laparoscopic cholecystectomy at assiut university Hospital
Complications of intraoperative spilled gallstones and bile in laparoscopic cholecystectomy (inta abdominal abscess and localized bile collection ) and follow up for late complications
Measured: Follow up complication for 6 months postoperative by abdominal ultrasound and multiple slice ct abdomen if needed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis; GallstoneStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar mohamed ahmed mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041726
- Sponsor's protocol ID
- Bile spillage intraoperative
- Status last verified
- Jul 2019
- First submitted
- 27 Jul 2019
- Last updated
- 1 Aug 2019
- 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 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Spillage of Bile and Gallstones During Laparoscopic Cholecysetectomy
- ClinicalTrials.gov ID
- NCT04041726
- Acronym / sponsor ID
- Bile spillage intraoperative
- Conditions
- Cholecystitis; Gallstone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 1 Aug 2019 (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.
- determine the most important factors which is responsible for the outcome post bile and gallstones spillage during laparoscopic cholecystectomy
- the management of complications of bile and gallstones spillage
Detailed description
Laparoscopic cholecystectomy is preferred surgical treatment for symptomatic gallstones .laparscopic procedure is superior to open procedue .the incidence of gallbladder perforation and spillage of bile and gallstones has been found as high as 40% .complications and management of gall bladder perforation and spillage of gallstones and bile
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Results from intraoperative spillage of bile and gallstones intra abdomen during laparascopic cholecystectomy
Key inclusion criteria (3 listed)
- all age groups
- only laparoscopic cholecystectomy
- all types ,numbers and sizes os gall stones
Key exclusion criteria (2 listed)
- open cholecystectomh
- patient refuse to enrol this study
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
Our purpose was to report the occurrence of complications following spilled gallstones during laparoscopic cholecystectomy at assiut university Hospital
Time frame: Follow up complication for 6 months postoperative by abdominal ultrasound and multiple slice ct abdomen if needed
Complications of intraoperative spilled gallstones and bile in laparoscopic cholecystectomy (inta abdominal abscess and localized bile collection ) and follow up for late complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
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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; Gallstone, 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 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: status not confirmed, as of the sponsor's last update on 1 Aug 2019. 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 Omar mohamed Ahmed Mohamed (00201022533837, Omarmakhlof1993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Our purpose was to report the occurrence of complications following spilled gallstones during laparoscopic cholecystectomy at assiut university Hospital (time frame: Follow up complication for 6 months postoperative by abdominal ultrasound and multiple slice ct abdomen if needed). 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 1 Aug 2019.