- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05770128
Subserosal Laparoscopic Cholecystectomy
March 14, 2023 updated by: Ahmed Mohammed Hussein Ali, Assiut University
Subserosal Laparoscopic Cholecystectomy for Safe Gall Bladder Surgery
The aim is to study the safety and efficacy of subserosal laparoscopic cholecystectomy .
Study Overview
Study Type
Observational
Enrollment (Anticipated)
65
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ahmed M. Hussein, resident
- Phone Number: +201010729020
- Email: ahmed.s7s1929@gmail.com
Study Contact Backup
- Name: Abdallah B. Abdallah, professor
- Phone Number: +201000002283
- Email: badawy@aun.edu.eg
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
any patient admitted to surgical department wth age above 18 years old suffering & diagnosed of chronic cholecystitis , symptomatic cholelithiasis
Description
Inclusion Criteria:
- Adult with age of or above 18 years.
- Diagnosis of chronic cholecystitis , symptomatic cholelithiasis
Exclusion Criteria:
- Previous operation or adhesion
- severe Acute Calculus pancreatitis
- gall bladder cancer
- Severe co-morbid conditions (uncontrolled diabetes, Hypertension, severe direct hyper bilirubinemia)
- Recurrent cases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2023
Primary Completion (Anticipated)
November 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
October 25, 2021
First Submitted That Met QC Criteria
March 14, 2023
First Posted (Actual)
March 15, 2023
Study Record Updates
Last Update Posted (Actual)
March 15, 2023
Last Update Submitted That Met QC Criteria
March 14, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- cholecystectomy by laparoscpe
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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