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Evaluation Of Preoperative Scoring Method For Peridiction Of Difficult Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03718572
Recruitment Status : Unknown
Verified October 2018 by AbdElRhman Mohamed Ahmed, Assiut University.
Recruitment status was:  Recruiting
First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
AbdElRhman Mohamed Ahmed, Assiut University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Evaluation Studies Procedure: Laparoscopic cholecystectomy

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 Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation Of Preoperative Scoring Method For Peridiction Of Difficult Laparoscopic Cholecystectomy
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : September 1, 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
Scoring factors Procedure: Laparoscopic cholecystectomy
Surgical removal of Gall bladder using laparoscopy
Difficulty criteria Procedure: Laparoscopic cholecystectomy
Surgical removal of Gall bladder using laparoscopy


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults male and female age of or above 18 years
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718572


Contacts
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Contact: AbdElRhman Mohamed, Dr 0201065787845 elabassi1001@gmail.com

Locations
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Egypt
Assiut University hospitals Recruiting
Assiut, Egypt
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: AbdElRhman Mohamed Ahmed, Resident, Assiut University
ClinicalTrials.gov Identifier: NCT03718572    
Other Study ID Numbers: AssiutU1001
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No