Assessment of Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis (Multicentric Study)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 900
- Locations
- 1
- Primary Endpoint
- the incidence of postoperative morbidity
Study Overview
Brief Summary
The ideal timing for ELC continues to be debatable in patients with acute calculator cholecystitis (ACC). This study was planned to identify the impact of different ELC timing in ACC on surgical outcomes in terms of safety and efficacy
Detailed Description
This multicentric analysis involved of successive patients with ACC ELC between April 2018 and March 2020. Patients were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2), and beyond 7 days (group 3). The primary outcome was the incidence of postoperative complications The secondary outcomes were conversion rate, blood loss, operative times, operational difficulty, the cost-benefit relationship, postoperative stay with each treatment line.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Patients were divided into three groups according to the timing of the surgery: from the onset of symptoms within the first 3 days (group 1), between 4 and 7 days (group 2) and beyond 7 days (group 3).
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ACC patients who underwent early LC
Exclusion Criteria
- •Pregnancy, Acalculous cholecystitis, CBDS, Ascending cholangitis, Pancreatitis, ASA score 4, Patients scheduled for DLC with failed medical treatment.
Arms & Interventions
from the onset of symptoms beyond 7 days
ELC for ACC from the onset of symptoms beyond 7 days (group III)
Intervention: from the onset of symptoms beyond 7 days (Procedure)
from the onset of symptoms within the first 3 days (group 1)
ELC for ACC from the onset of symptoms within the first 3 days (group 1)
Intervention: from the onset of symptoms within the first 3 days (Procedure)
from the onset of symptoms within the 4-7 days
ELC for ACC from the onset of symptoms within the4-7 days (group II)
Intervention: : from the onset of symptoms within the 4-7 days (Procedure)
Outcomes
Primary Outcomes
the incidence of postoperative morbidity
Time Frame: 30 DAYS
the incidence of postoperative morbidity during the 30th day of postoperative procedure
Secondary Outcomes
- conversion rate(INTRAOPERATIVE)
- blood loss(intraoperative)
- hospital stay(30 days)
Investigators
Ayman El Nakeeb
gastrointestinal surgical center, Mansoura University
Mansoura University