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the Outcomes of Laparoscopic Cholecystectomy for Acute Cholecystitis Within and Beyond the First 72 Hours, Does it Differ?!

the Outcomes of Laparoscopic Cholecystectomy for Acute Cholecystitis Within and Beyond the First 72 Hours, Does it Differ?!

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06459323
Enrollment
20
Registered
2024-06-14
Start date
2025-03-01
Completion date
2026-05-01
Last updated
2024-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Cholecystitis

Brief summary

Compare outcomes of patients undergoing early laparoscopic cholecystectomy within and after72 hours of symptoms.

Detailed description

Laparoscopic cholecystectomy (LC) is the mainstay treatment of acute cholecystitis. However, it remains a challenging procedure with low but significant risks of major complications such as bile duct injury increasing as the severity of AC progresses. New Guidelines suggest that laparoscopic cholecystectomy should preferably be performed within 72 hrs of symptom onset but has acknowledged that this may not be always possible in practice. Hence, it recommends that patients presenting after 72 h of symptom onset may still benefit from laparoscopic cholecystectomy in selected patients Studies found that it is imperative to convert to open cholecystectomy when it is deemed unsafe to dissect the Calot's triangle may occur even within or beyond first 72 hrs of attck symptoms. studies found a statistically longer mean total length of hospitalization, operation time and intraoperative blood loss for LC performed beyond 72 h, this did not translate into clinically significant adverse outcomes such as an increase in perioperative morbidity or the need for blood transfusion. After 72 h, chronic inflammation and fibrosis set in resulting in more technically demanding and longer surgeries.Studies show differing results reporting longer operation times for laparoscopic cholecystectomy beyond 72 h, due to stiffer tissues that cannot be bluntly dissected during the subacute phase of tissue inflammation. However, other studies did not report any difference in operation times between both groups.

Interventions

PROCEDURELaparoscopic cholecystectomy

Laparoscopic cholecystectomy

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. Patients with acute cholecystitis within and after 72 hours. 2. Patients over 18 years. 3. Patients with no common bile duct stones based on imaging and biochemical criteria 4. Fit for surgery.

Exclusion criteria

1. Patients not fit for surgery 2. Patients with Pancreatitis. 3. Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g. Uncontrolled Diabetes Mellitus, Chronic Pulmonary Disease, significant Cardiac Disease)

Design outcomes

Primary

MeasureTime frameDescription
Bile duct injury , intraoperative bleeding and operative timeOne weekEvaluate bile duct integrity, calculate amount of blood loss and operative time from the start till the end

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026