Brief Title
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
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.
Study Type
Interventional
Primary Outcome
Number of participants and Rate of Post-operative complications
Secondary Outcome
Mean and Standard deviation of Operative duration (hours) (mean±SD)
Condition
Acute Cholecystitis
Intervention
Early laparoscopic cholecystectomy
Study Arms / Comparison Groups
Group E: Early LC (n=60)
Description: Early laparoscopic cholecystectomy (within 72h from symptom onset)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
120
Start Date
September 1, 2017
Completion Date
April 30, 2019
Primary Completion Date
April 30, 2019
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
Gender
All
Ages
21 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Mohamed M Abdalgaleil, MD, ,
Location Countries
Egypt
Location Countries
Egypt
Administrative Informations
NCT ID
NCT03999645
Organization ID
DTH:19002
Responsible Party
Sponsor
Study Sponsor
Damanhour Teaching Hospital
Study Sponsor
Mohamed M Abdalgaleil, MD, Principal Investigator, Damanhour Teaching Hospital
Verification Date
June 2019