Ignite Creation Date:
2024-05-06 @ 4:24 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04979936
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2021-07-17
Brief Title:
Early Laparoscopic Cholecystectomy Versus Percutaneous Cholecystostomy in Grade II Acute Cholecystitis Guidelines
Sponsor:
Alexandria University
Organization:
Alexandria University
Study Overview
Official Title:
Early Laparoscopic Cholecystectomy Versus Percutaneous Cholecystostomy Followed by Delayed Laparoscopic Cholecystectomy in Patients With Grade II Acute Cholecystitis According to Tokyo Guidelines
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PC
Brief Summary:
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
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 Institutions Ethics Committee was obtained from all the treated patients
Exclusion criteria
-contraindication to laparoscopyRefusal 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
1 History
2 Examination
3 Investigations pre and postoperative
Laboratory WBC CRP lever functions Radiologic imaging ultrasonography CT abdomen
4 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
5 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
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 Institutions Ethics Committee was obtained from all the treated patients
Exclusion criteria
-contraindication to laparoscopyRefusal 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
1 History
2 Examination
3 Investigations pre and postoperative
Laboratory WBC CRP lever functions Radiologic imaging ultrasonography CT abdomen
4 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
5 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None