Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days?

Damanhour Teaching Hospital120 enrolled

Overview

Objectives: To compare the safety of early (≤72h) versus late (\>72h-7days) laparoscopic cholecystectomy (LC) from symptom onset for acute cholecystitis (AC). Background: As LC within 72h of symptom onset was considered the optimum time, sometimes there was a delay in diagnosis and management. So, we raised the question of safety and feasibility of performing LC to patients with AC who failed to have LC within 72h of acute attack. Patients and Methods: This was a prospective, randomized, double-blind, clinical trial; carried out on 120 patients presented with AC between September 2017 and April 2019. Patients were randomly allocated into two equal groups assigned to LC; group E: within 72h of symptom onset, and group L: after 72h up to seven days from symptom onset.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

120

Conditions

Acute Cholecystitis

Interventions

Eligibility

Sex: ALLMin age: 21 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with AC within seven days from symptom onset * American Society of Anesthesiologist (ASA) physical status ≤ II * Age from 21 to 60 years Exclusion Criteria: * Patients with ASA physical status \> II * Age \< 21 years or \> 60 years * Child classification B or C * Choledocholithiasis * Acute pancreatitis * Severe sepsis * Gallbladder perforation * Pregnant women

Outcomes

Primary Outcomes

Number of participants and Rate of Post-operative complications

Number of participants and Rate of: Post-operative bleeding, Fluid collection, Bile leak, Port-site infection, Revision surgery, Mortality rate

Time frame: 30 days post-operatively

Secondary Outcomes

Mean and Standard deviation of Operative duration (hours) (mean±SD)

Mean and Standard deviation of Operative duration (hours)

Time frame: from surgical incision till suture closure

Mean and Standard deviation of Intra-operative blood loss (ml) (mean±SD)

Mean and Standard deviation of Intra-operative blood loss (ml)

Time frame: from surgical incision till suture closure

Number of participants and Rate of Conversion to open cholecystectomy

Time frame: from the start till the end of surgical procedure

Mean and Standard deviation of Length of hospital stay (days) (mean±SD)

Mean and Standard deviation of Length of hospital stay (days)

Time frame: from hospital admission till home discharge within 30 days