Early Laparoscopic Cholecystectomy Versus Percutaneous Cholecystostomy in Grade II Acute Cholecystitis Guidelines

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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