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Completed

NCT Number: NCT04405713

Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis

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

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Key information

Conditions

Acute Cholecystitis Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohamed Attea

Al Mansurah, 356111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

from the onset of symptoms within the first 3 days

Procedure

ELC within 3 days of onset of ACC

Other names: group 1

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

Procedure

ELC 4-7days of onset of ACC

Other names: Group II

from the onset of symptoms beyond 7 days

Procedure

ELC after 7days of onset of ACC

Other names: Group III

Primary outcomes

  1. the incidence of postoperative morbidity

    Time frame: 30 DAYS

    the incidence of postoperative morbidity during the 30th day of postoperative procedure

Secondary outcomes

  1. conversion rate

    Time frame: INTRAOPERATIVE

    conversion rate to open cholecystectomy

  2. blood loss

    Time frame: intraoperative

    blood loss

  3. hospital stay

    Time frame: 30 days

    overall hospital stay

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Assessment of Different Timing for Early Laparoscopic Cholecystectomy in Acute Calcular Cholecystitis (Multicentric Study)

Acronym: ACC

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 28, 2020
Registry last updated
May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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