Clinical trial NCT03999645: Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days?
Official title: Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days? A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Cholecystitis
Keywords: Acute cholecystitis
Early laparoscopic cholecystectomy
Gallbladder disease
Late laparoscopic cholecystectomy
Lead sponsor: Damanhour Teaching Hospital
Sponsor class: OTHER_GOV
First posted: 2019-06-27
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants and Rate of Post-operative complications
timeFrame: 30 days post-operatively
Secondary outcomes:
measure: Mean and Standard deviation of Operative duration (hours) (mean±SD)
timeFrame: from surgical incision till suture closure
measure: Mean and Standard deviation of Intra-operative blood loss (ml) (mean±SD)
timeFrame: from surgical incision till suture closure
measure: Number of participants and Rate of Conversion to open cholecystectomy
timeFrame: from the start till the end of surgical procedure
measure: Mean and Standard deviation of Length of hospital stay (days) (mean±SD)
timeFrame: from hospital admission till home discharge within 30 days
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Teaching Hospital
state: El-Beheira
Study officials:
affiliation: Damanhour Teaching Hospital
name: Mohamed M Abdalgaleil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Damanhour Teaching Hospital
name: Ahmed M Shaat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Damanhour Teaching Hospital
name: Osama S Elbalky, MD
role: STUDY_DIRECTOR
affiliation: Damanhour Teaching Hospital
name: Mamdouh M Ibrahim, MD
role: STUDY_CHAIR
affiliation: Damanhour Teaching Hospital
name: Mohamed S Elnagar, MD
role: STUDY_CHAIR
References: