the Outcomes of Laparoscopic Cholecystectomy for Acute Cholecystitis Within and Beyond the First 72 Hours, Does it Differ?!
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 20
- Primary Endpoint
- Bile duct injury , intraoperative bleeding and operative time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with acute cholecystitis within and after 72 hours.
- •Patients over 18 years.
- •Patients with no common bile duct stones based on imaging and biochemical criteria
- •Fit for surgery.
Exclusion Criteria
- •Patients not fit for surgery
- •Patients with Pancreatitis.
- •Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g. Uncontrolled Diabetes Mellitus, Chronic Pulmonary Disease, significant Cardiac Disease)
Arms & Interventions
Laparoscopic cholecystectomy within first 72hours
Intervention: Laparoscopic cholecystectomy (Procedure)
Laparoscopic cholecystectomy beyond first 72hours
Intervention: Laparoscopic cholecystectomy (Procedure)
Outcomes
Primary Outcomes
Bile duct injury , intraoperative bleeding and operative time
Time Frame: One week
Evaluate bile duct integrity, calculate amount of blood loss and operative time from the start till the end
Secondary Outcomes
No secondary outcomes reported
Investigators
Ahmed Refaat Mansour
Resident of general surgery Assiut university hospital
Assiut University
