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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Cholecystitis, Pain, Morbidity, Multiple, Surgery, Drain Site Complication

Intervention / Treatment
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* Other: Suction drain


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study objective is to compare the frequency of pain and mean hospital stay in patients with and without drain insertion, following laparoscopic cholecystectomy for acutely inflamed gallbladder.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drain Group<br>Suction drain was placed in sub hepatic region through 5 mm lateral trocar site. | Other: Suction drain<br>* Post operatively, in both arms including drain group and no drain group, parameters of pain was assessed by visual analog scale (VAS) from 0 (no pain) to 10 (worst pain), assessed at 1st postoperative day by the duty doctor or the nurse. VAS > 3 was considered as post surgical pain. The total number of hospital stay was noted from the day of operation till the day of discharge and discharge criteria was taken as a patient having pain as per VAS<3, no fever and tolerating oral intake<br>|
| No Intervention: Without Drain Group<br>No drain was placed | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain was assessed by VISUAL ANALOGUE SCALE (VAS) from 0 to 10, taking 0 SCORE FOR NO PAIN AND MAXIMUM 10 SCORE FOR WORST PAIN, assessed at 1st postoperative day by the duty doctor or the nurse. VAS > 3 was considered as post surgical pain. | 1st post operative day | 
| Mean Hospital stay | Number of days from the day of operation till the day of discharge and discharge criteria was taken as a patient having pain as per VISUAL ANALOGUE SCALE <3 (0 SCORE FOR NO PAIN AND MAXIMUM 10 SCORE FOR WORST PAIN), no fever and tolerating oral intake. | 1st to 5th post operative day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, Hospital stay, Drain insertion, Laparoscopic cholecystectomy, Acutely inflammed gall bladder