Brief Title
Early Laparoscopic Cholecystectomy Versus Percutaneous Cholecystostomy in Grade II Acute Cholecystitis Guidelines
Official Title
Early Laparoscopic Cholecystectomy Versus Percutaneous Cholecystostomy Followed by Delayed Laparoscopic Cholecystectomy in Patients With Grade II Acute Cholecystitis According to Tokyo Guidelines
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 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:
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 Type
Interventional
Primary Outcome
operative difficulties as conversion, operative time, biliary injury
Condition
Acute Cholecystitis
Intervention
laparoscopic cholecystectomy
Study Arms / Comparison Groups
early laparoscopic cholecystectomy
Description: early laparoscopic cholecystectomy
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
220
Start Date
January 1, 2016
Completion Date
January 31, 2021
Primary Completion Date
January 31, 2021
Eligibility Criteria
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
Gender
All
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
HANY MK EL-HADDAD, professor, ,
Location Countries
Egypt
Location Countries
Egypt
Administrative Informations
NCT ID
NCT04979936
Organization ID
17/11
Responsible Party
Sponsor
Study Sponsor
Alexandria University
Study Sponsor
HANY MK EL-HADDAD, professor, Principal Investigator, alexandria university, faculty of medicine
Verification Date
July 2021