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

A

Assiut University

Status

Not yet enrolling

Conditions

Acute Cholecystitis

Treatments

Procedure: Laparoscopic cholecystectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT06459323
Cholecystectomy timing

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Laparoscopic cholecystectomy within first 72hours
Experimental group
Treatment:
Procedure: Laparoscopic cholecystectomy
Laparoscopic cholecystectomy beyond first 72hours
Experimental group
Treatment:
Procedure: Laparoscopic cholecystectomy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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