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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04346550
• Other study ID #: Sheikh
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: October 17, 2018

Study information

• Verified date: April 2020
• Source: Shifa International Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 17, 2018
• Est. primary completion date: October 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Pakistan	Shifa International Hospital	Islamabad	Federal Capital

Sponsors (1)

Lead Sponsor	Collaborator
Shifa International Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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