Skip to main content
Clinical Trials/NCT06459323
NCT06459323Not yet recruitingNot Applicable

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

Assiut University0 sites20 target enrollmentStarted: March 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
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

Experimental

Intervention: Laparoscopic cholecystectomy (Procedure)

Laparoscopic cholecystectomy beyond first 72hours

Experimental

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Refaat Mansour

Resident of general surgery Assiut university hospital

Assiut University

Similar Trials