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

NCT ID: NCT06459323

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-05-01

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.

Conditions

Acute Cholecystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Laparoscopic cholecystectomy within first 72hours

Group Type: EXPERIMENTAL

Laparoscopic cholecystectomy

Intervention Type: PROCEDURE

Laparoscopic cholecystectomy

Laparoscopic cholecystectomy beyond first 72hours

Group Type: EXPERIMENTAL

Laparoscopic cholecystectomy

Intervention Type: PROCEDURE

Laparoscopic cholecystectomy

Interventions

Laparoscopic cholecystectomy

Laparoscopic cholecystectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Refaat Mansour

Resident of general surgery Assiut university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Related Links

http://doi.org/10.1007/s00464-012-2206-7

Navez, B., Ungureanu, F., Michiels, M. et al. Surgical management of acute cholecystitis: results of a 2-year prospective multicenter survey in Belgium. Surg Endosc 26, 2436-2445 (2012).

Other Identifiers

Cholecystectomy timing

Identifier Type: -

Identifier Source: org_study_id