Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis (ACC)

Mansoura University

Status: Completed

Conditions: Acute Cholecystitis

Treatments: Procedure: : from the onset of symptoms within the 4-7 days; Procedure: from the onset of symptoms within the first 3 days; Procedure: from the onset of symptoms beyond 7 days

Study type: Interventional

Funder types: Other

Identifiers

NCT04405713

early LC for ACC

Details and patient eligibility

About

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

Full 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.

Enrollment: 900 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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900 participants in 3 patient groups

from the onset of symptoms within the first 3 days (group 1)

Active Comparator group

Description:

ELC for ACC from the onset of symptoms within the first 3 days (group 1)

Treatment:

Procedure: from the onset of symptoms within the first 3 days

from the onset of symptoms within the 4-7 days

Active Comparator group

Description:

ELC for ACC from the onset of symptoms within the4-7 days (group II)

Treatment:

Procedure: : from the onset of symptoms within the 4-7 days

from the onset of symptoms beyond 7 days

Active Comparator group

Description:

ELC for ACC from the onset of symptoms beyond 7 days (group III)

Treatment:

Procedure: from the onset of symptoms beyond 7 days