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