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

Not Applicable

Completed

• Conditions: Pain; Surgery; Morbidity, Multiple; Acute Cholecystitis; Drain Site Complication
• Interventions: Other: Suction drain

• Registration Number: NCT04346550
• Lead Sponsor: Shifa International Hospital

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 Timeline

• Study Start: 2017-10-02
• Primary Completion: 2018-10-17
• Study Completion: 2018-10-17
• Status Verified: 2020-04
• Study First Submitted: 2020-04-12
• Study First Submitted QC: 2020-04-12
• Last Update Submitted: 2020-04-14
• Study First Posted: 2020-04-15
• Last Update Posted: 2020-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pain intensity	1st post operative day	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.
Mean Hospital stay	1st to 5th post operative day	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.

Trial Locations

Locations (1)

Shifa International Hospital; 🇵🇰 Islamabad, Federal Capital, Pakistan