An interventional study of laparoscopic cholecystectomy and percutaneous cholecystostomy in Acute Cholecystitis and Empyema, Gallbladder, sponsored by Alexandria University. Completed at 2 sites in Egypt. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-07-28.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
Among 10 studies in Cholecystitis, Acute with a site in Egypt — none open to participants now, none under way, none of them phase 3. Cholecystitis, Acute · Egypt.
Among the 10 studies in Cholecystitis, Acute with a site in Egypt, this one is the 4th largest by enrollment, is the only one that started in 2016, is one of 9 with no phase, and was the 5th registered.
140 studies on the registry are indexed under Cholecystitis, Acute; 30 are open to participants now.
Browse Cholecystitis, Acute studies →None of the 10 studies in Cholecystitis, Acute with a site in Egypt is open now.
Of the 20 Cholecystitis, Acute studies recruiting now, 16 (80%) set no upper age limit and 2 (10%) stop at 75 or younger; 2 take children under 18; 0 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 1 started in 2016.
This study's enrollment of 220 is above the median of 90 across 84 interventional studies indexed under Cholecystitis, Acute.
Median enrollment 147 across the 10 interventional studies. Of the 8 that completed or were terminated, 0 (0%) have results posted.
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None of the 10 has an industry lead sponsor. The 9 most frequent:
Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Alexandria University has 1 study filed under Cholecystitis, Acute — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Cholecystitis, Acute with a site in Egypt, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The aim of this study is to compare between early laparoscopic cholecystectomy versus percutaneous cholecystostomy followed by delayed interval laparoscopic cholecystectomy as regards the operative and postoperative complications
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:
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
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
early laparoscopic cholecystectomy
Procedure: laparoscopic cholecystectomy
percutaneous cholecystostomy first followed by delayed laparoscopic cholecystectomy
Procedure: percutaneous cholecystostomy
operative difficulties as conversion, operative time, biliary injury
as assessed by the main surgeon
Time frame: at the time of cholecysctomy
postoperative complications
as assessed by clavien dindo classification
Time frame: 30 days after the operation
Plan to share: No — data extracted from the hospital records. it is difficult to bring these data into public
No publications or documents are linked to this record.
Ran from Jan 2016 to primary completion in Jan 2021, 60 months.
Of 42 non-industry interventional studies with no phase under Cholecystitis, Acute, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's 60 months is above that.
Counting every sponsor, half of 45 studies reached it within 20 months; a quarter within 9 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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