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

NCT04346550 | Completed DMC

• 1 other identifier: Sheikh
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

pain; Hospital stay; Drain insertion; Laparoscopic cholecystectomy; Acutely inflammed gall bladder

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Drain Group

ACTIVE COMPARATOR

Suction drain was placed in sub hepatic region through 5 mm lateral trocar site.

Other: Suction drain

Without Drain Group

NO INTERVENTION

No drain was placed

Interventions

Suction drain OTHER

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

Drain Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shifa International Hospital: lead

Study Sites (1)

Shifa International Hospital

Islamabad, Federal Capital, 44790, Pakistan

Location

MeSH Terms

Conditions

Cholecystitis, Acute; Pain

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hira Saleem, FCPS Surgery

  Shifa International Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Resident, Principal Investigator.

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 15, 2020
• Study Start: October 2, 2017
• Primary Completion: October 17, 2018
• Study Completion: October 17, 2018
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)