- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04979936
Early Laparoscopic Cholecystectomy Versus Percutaneous Cholecystostomy in Grade II Acute Cholecystitis Guidelines (PC)
Early Laparoscopic Cholecystectomy Versus Percutaneous Cholecystostomy Followed by Delayed Laparoscopic Cholecystectomy in Patients With Grade II Acute Cholecystitis According to Tokyo Guidelines
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A-Study setting: Department of Surgery, main university hospital, Faculty of Medicine, Alexandria University, Egypt. The study was approved by the Ethics Committee of our institution.
B-Study design: Retrospective clinical trial C-Study subjects: The target population are patients with preoperative diagnosis of grade II acute cholecystitis Those patients were subjected to surgery either early laparoscopic cholecystectomy or delayed laparoscopic cholecystectomy after percutaneous cholecystostomy
Inclusion criteria of the study patients:
-Specific written informed consent approved by our Institution's Ethics Committee was obtained from all the treated patients.
Exclusion criteria:
-contraindication to laparoscopy,Refusal of study participation, cirrhosis, grade I or III acute cholecystitis D-Sample size calculation: a minimum sample size required per group is 88 to detect decline in the proportion of the primary outcome from 20% to 5%, at 5% level of significance and 80% power.
E-Sampling technique: By using eligibility criteria, 220 patients that were planned to undergo laparoscopic Cholecystectomy were randomly selected from the surgery department in main university hospital, Faculty of Medicine, Alexandria University. They were randomly separated into two groups:
An experiment group: (90 patients) underwent percutaneous cholecystostomy followed by delayed interval laparoscopic cholecystectomy A control group: (130 patients) underwent early laparoscopic cholecystectomy. All the participants were initially evaluated and re-evaluated during follow up period of 30 days for the outcome measures. Non blinded trial was done due to difficulty in using blinding in operative intervention.
Methods: every patient in the study sample was subjected to the followings:
- History
- Examination:
Investigations ( pre and postoperative):
Laboratory: WBC, CRP, lever functions Radiologic imaging: ultrasonography, CT abdomen
Intervention: An experiment group: underwent percutaneous cholecystostomy followed by delayed interval laparoscopic cholecystectomy.
A control group: underwent early laparoscopic cholecystectomy.
Surgical Technique: laparoscopic cholecysctomy Postoperative Course: post-operative complications
Outcome Measurement and Follow-Up
- Follow up period: both groups were re-evaluated at 1, 2, 6 months. They were evaluated for the positive and negative outcome measures. There were no cases lost to follow up.
- Outcome measures that were assessed after the follow up period were:
- Primary outcome measures: operative and postoperative complications as conversion, biliary injury, bowel injury, they were assessed by clavien dindo classification
- Secondary Outcome measures: ASA score, Tokyo score and some investigations.
Statistical analysis Statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS) version 20 software (SPSS, Inc., Chicago, IL, USA). Quantitative variables were summarized using mean and standard deviation after data exploration using the Kolmogorov- Smirnov test. Qualitative variables were described using number and percent. Associations between the two groups and other categorical variables were assessed using Chi-square test (Fisher or Monte Carlo). Comparisons between the two groups as regards the quantitative variables were assessed using Student t-test. All Statistical tests were done at 5% level of Significance.
Risk estimates were calculated as Relative risk, Absolute risk reduction, Number needed to treat and population Attributable Risk percentage to detect the risk of development of the intraoperative and postoperative complications in the intervention and control group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Alexandria, Egypt
- Alexandria University
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Alexandria, Egypt
- Faculty of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients with one of the criteria stated by grade II (moderate) Tokyo guidelines for acute cholecystitis who were managed either by early LC or by a bridging PC followed by delayed LC.
Exclusion Criteria:
- grade I or III acute cholecystitis
- common bile duct stones or jaundice,
- Liver cirrhosis,
- severe upper abdominal adhesions,
- acalculous cholecystitis
- major comorbidities in which laparoscopic surgery is contraindicated.
- those who followed a conservative treatment for acute cholecystitis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: early laparoscopic cholecystectomy
|
|
ACTIVE_COMPARATOR: percutaneous cholecystostomy
percutaneous cholecystostomy first followed by delayed laparoscopic cholecystectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
operative difficulties as conversion, operative time, biliary injury
Time Frame: at the time of cholecysctomy
|
as assessed by the main surgeon
|
at the time of cholecysctomy
|
postoperative complications
Time Frame: 30 days after the operation
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as assessed by clavien dindo classification
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30 days after the operation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: HANY MK EL-HADDAD, professor, Alexandria University, Faculty of Medicine
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17/11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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