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

Acute Cholecystitis Clinical Trial

— RCT  

Official title:

Is it Safe to do Laparoscopic Cholecystectomy for Acute Cholecystitis up to Seven Days? A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03999645
• Other study ID #: DTH:19002
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: June 2019
• Source: Damanhour Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute

Intervention

Procedure:
• Early laparoscopic cholecystectomy
within 72h from symptom onset
• Late laparoscopic cholecystectomy
after 72h up to seven days from symptom onset

Locations

Country	Name	City	State
Egypt	Damanhour Teaching Hospital	Damanhur	El-Beheira

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour Teaching Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days post-operatively
Secondary	Mean and Standard deviation of Operative duration (hours) (mean±SD)	Mean and Standard deviation of Operative duration (hours)	from surgical incision till suture closure
Secondary	Mean and Standard deviation of Intra-operative blood loss (ml) (mean±SD)	Mean and Standard deviation of Intra-operative blood loss (ml)	from surgical incision till suture closure
Secondary	Number of participants and Rate of Conversion to open cholecystectomy	Number of participants and Rate of Conversion to open cholecystectomy	from the start till the end of surgical procedure
Secondary	Mean and Standard deviation of Length of hospital stay (days) (mean±SD)	Mean and Standard deviation of Length of hospital stay (days)	from hospital admission till home discharge within 30 days