Evaluation Of Preoperative Scoring Method For Peridiction Of Difficult Laparoscopic Cholecystectomy
October 23, 2018 updated by: AbdElRhman Mohamed Ahmed, Assiut University
Registering and observing clinical and radiological data of patients undergoing laparoscopic cholecystectomy, then formulating these data aiming to find helpful scoring system to predict difficulty of 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 30 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)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Assiut, Egypt
- Recruiting
- Assiut university hospitals
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-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adults male and female age of or above 18 years
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 factors
|
Surgical removal of Gall bladder using laparoscopy
|
|
Difficulty criteria
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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: 6 monthes
|
Validation of sensitivity and specificity of Scoring system to predict difficulty of laparoscopic cholecystectomy
|
6 monthes
|
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)
January 1, 2019
Primary Completion (Anticipated)
June 1, 2019
Study Completion (Anticipated)
September 1, 2019
Study Registration Dates
First Submitted
October 23, 2018
First Submitted That Met QC Criteria
October 23, 2018
First Posted (Actual)
October 24, 2018
Study Record Updates
Last Update Posted (Actual)
October 24, 2018
Last Update Submitted That Met QC Criteria
October 23, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- AssiutU1001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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.