Comparison of Morbidity After Laparoscopic Cholecystectomy for Acutely Inflamed Gall Bladder With and Without Drain

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Brief Title

Comparison of Morbidity After Laparoscopic Cholecystectomy for Acutely Inflamed Gall Bladder With and Without Drain

Official Title

Comparison of Morbidity After Laparoscopic Cholecystectomy for Acutely Inflamed Gall Bladder With and Without Drain

Brief Summary

      The purpose of this study was to compare the frequency of pain and mean hospital stay in
      patients with and without drain insertion, following laparoscopic cholecystectomy for acutely
      inflamed gallbladder.
    

Detailed Description

      Most hospitals in Pakistan still do not have a policy of early laparoscopic cholecystectomy
      in acutely inflamed gallbladder, partly because of feared higher conversion rates to open
      procedure and presumed increased risk of complications. There are fewer local studies to
      elaborate the role of drain after laparoscopic cholecystectomy for acutely inflamed
      gallbladder. This study was conducted to analyze the role of routine use of drains after
      laparoscopic cholecystectomy for acutely inflamed gallbladder. Does it offer any advantage in
      detecting bile leak or bleeding. Also to prove that placing drains prolongs the hospital stay
      and increases postoperative pain in comparison to patients in whom drain is not placed.

      After being informed about the study and the potential risks, all patients giving written
      informed consent, underwent laparoscopic cholecystectomy using conventional 4 port method.
      Patients were divided in two groups by lottery method. Group A - no drain group and Group B -
      drain group. Post operatively parameters of pain and total hospital stay were assessed and
      analysed.
    


Study Type

Interventional


Primary Outcome

Pain intensity


Condition

Acute Cholecystitis

Intervention

Suction drain

Study Arms / Comparison Groups

 Drain Group
Description:  Suction drain was placed in sub hepatic region through 5 mm lateral trocar site.

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

Other

Estimated Enrollment

60

Start Date

October 2, 2017

Completion Date

October 17, 2018

Primary Completion Date

October 17, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  All the patients of either sex with ages between 20 - 80 years, diagnosed with acutely
             inflamed gallbladder, undergoing laparoscopic cholecystectomy were included in the
             study

        Exclusion Criteria:

          -  All patients having concurrent operations on other organs, or with history of previous
             upper abdominal surgery, or with immunodeficiency states because of liver or renal
             transplantation or already diagnosed with HIV infection, or surgeries requiring open
             conversions, or surgeries in which there was hollow visceral organ injury, or patient
             requiring common bile duct (CBD) exploration or patients having any bleeding disorder,
             or surgeries where there is doubt of cystic duct stump or CBD injury, were excluded
             from the study
      

Gender

All

Ages

20 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Hira Saleem, FCPS Surgery, , 

Location Countries

Pakistan

Location Countries

Pakistan

Administrative Informations


NCT ID

NCT04346550

Organization ID

Sheikh


Responsible Party

Principal Investigator

Study Sponsor

Shifa International Hospital


Study Sponsor

Hira Saleem, FCPS Surgery, Principal Investigator, Shifa International Hospital


Verification Date

April 2020