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

M

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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