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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Surgery; Acute Cholecystitis; Morbidity, Multiple; Drain Site Complication
• Intervention / Treatment: Other: Suction drain

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Federal Capital
    • Islamabad, Federal Capital, Pakistan, 44790
      • Shifa International Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Drain Group; Suction drain was placed in sub hepatic region through 5 mm lateral trocar site.	Other: Suction drain; 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
No Intervention: Without Drain Group; No drain was placed

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shifa International Hospital
• Investigators: Principal Investigator: Hira Saleem, FCPS Surgery, Shifa International Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): October 17, 2018
• Study Completion (Actual): October 17, 2018

Study Registration Dates

• First Submitted: April 12, 2020
• First Submitted That Met QC Criteria: April 12, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2020
• Last Update Submitted That Met QC Criteria: April 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: pain; Laparoscopic cholecystectomy; Hospital stay; Drain insertion; Acutely inflammed gall bladder
• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: Sheikh

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No