- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04569370
A Scoring System for Difficult Laparoscopic Cholecystectomy
September 24, 2020 updated by: Abobakr Mahfouz Abobakr, Assiut University
A Scoring System for Laparoscopic Cholycystectomy to Pick up Difficult Cases
Laparoscopic cholecystectomy is the treatment of choice for gall bladder stone disease.
Difficult laparoscopic cholecystectomy (LC) is the most common "difficult" surgical procedure performed today, which possesses the potential to place the patient at significant operative risk.The aim of this study was to put a scoring system to avoid difficult laparoscopic cholecystectomy.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Patients with symptomatic chronic calculous cholecystitis based on clinical and radiological correlation undergoing elective laparoscopic cholecystectomy at Assiut University hospitals will be included for the study of 100 patients will operated by single experienced laparoscopic surgeon.The scores are given on history, clinical examination and radiological findings one day prior to surgery on admission.
Study Type
Observational
Enrollment (Anticipated)
100
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: Abobakr Mahfouz Abobakr, Resident
- Phone Number: 00201554228866 00201066336030
- Email: karemmahfouz99@yahoo.com
Study Contact Backup
- Name: Besher Abo-el soud, Doctor
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 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with symptomatic chronic calculous cholecystitis based on clinical and radiological correlation undergoing elective laparoscopic cholecystectomy at Assiut University hospitals
Description
Inclusion Criteria:
- Adults male and female age of or above 18 years
- Symptomatic chronic calculous cholecystitis
- Ultrasound confirmed Gall bladder stones
Exclusion Criteria:
- Complicated chronic calculous cholecystitis
- Malignant Gall bladder
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Scoring Factor
Intervention: Procedure: Laparoscopic cholecystectomy
|
Surgical removal of Gall bladder using laparoscopy
|
Difficult criteria
Intervention: Procedure: Laparoscopic cholecystectomy
|
Surgical removal of Gall bladder using laparoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of preoperative scoring method for prediction of difficult laparoscopic cholecystectomy
Time Frame: 1 year
|
Validation of sensitivity and specificity of Scoring system to predict difficulty of laparoscopic cholecystectomy
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Salah Ibrahim, Prof, Professor at faculty of medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
October 1, 2020
Primary Completion (ANTICIPATED)
October 1, 2021
Study Completion (ANTICIPATED)
November 1, 2021
Study Registration Dates
First Submitted
September 24, 2020
First Submitted That Met QC Criteria
September 24, 2020
First Posted (ACTUAL)
September 29, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 29, 2020
Last Update Submitted That Met QC Criteria
September 24, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Scoring system for lap Choly
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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