Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy.

Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy: A Prospective Randomized Comparative Study

The aim of study is compare outcome of patients undergoing early laparoscopic cholecystectomy within 72 hours from the begging of symptoms to those of patients managed conservatively and operated late after 6-8weeks after the inflammatory reaction has subsided.

Study Overview

• Status: Not yet recruiting
• Conditions: Cholecystitis, Acute
• Intervention / Treatment: Procedure: Laparoscopic cholecystectomy

Detailed Description

Acute cholecystitis is considered one of the most common acute surgical problems. It includes typical symptoms of pain in right hypochondrium, fever, increased leucocytes count and abdominal US used to confirm this clinical diagnosis. Laparoscopic cholecystectomy (LC) is the standard treatment for acute cholecystitis due to the advantages of small wounds, less use of abdominal drains , less need for antibiotics and analgesics and less postoperative hospital stay time.Laparoscopic cholecystectomy in acute cholecystitis may be performed as soon as begging of the symptoms called emergency or urgent laparoscopic cholecystectomy and maybe scheduled in advance after controlling acute attack after 6-8weeks called elective laparoscopic cholecystectomy . Emergency laparoscopic cholecystectomy has advantage of a decreased hospital stay and avoids the risk of emergency admission for non-resolved or recurrent symptoms, which is associated with an increase in morbidity, pain and delayed return to work. Also, some trials showed increased morbidity with elective laparoscopic cholecystectomy mostly due to biliary disease while patients await surgery. Comparative studies are deficient in evaluation of outcomes of emergency cholecystectomy and elective cholecystectomy in acute cholecystitis. So the interest of our study is to compare between the emergency laparoscopic cholecystectomy and elective laparoscopic cholecystectomy regarding the feasibility and the safety of the first.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. age less than 70 years.
2. fit for surgery.

Exclusion Criteria:

1. patients with co-existent common bile duct stones based on imaging and biochemical criteria.
2. Patients with Pancreatitis .
3. Patients with previous upper abdominal surgery.
4. Significant medical disease rendering patient unfit for Laparoscopic surgery (e.g.Chronic Pulmonary Disease, significant Cardiac Disease)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Emergency Versus Elective Cholecystectomy in Acute Cholecystitis in the Era of Laparoscopy; A Prospective Randomized Comparative Study.

Procedure: Laparoscopic cholecystectomy; Laparoscopic cholecystectomy is the standard treatment for acute cholecystitis due to the advantages of small wounds, less use of abdominal drains , less need for antibiotics and analgesics and less postoperative hospital stay time.Laparoscopic cholecystectomy in acute cholecystitis may be performed as soon as begging of the symptoms called emergency or urgent and maybe scheduled in advance after controlling acute attack after 6-8weeks called elective.; Other Names: Emergency versus elective cholecystectomy in acute cholecystits in the era of laproscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of intraoperative complications in urgent versus elective lap cholecystostomy.	Collect results and see.	Intraoperative time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative complications in urgent versus elective lap cholecystectomy.	Collect results and see.	6 months.

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 14, 2022
• Primary Completion (ANTICIPATED): September 14, 2022
• Study Completion (ANTICIPATED): August 14, 2023

Study Registration Dates

• First Submitted: August 6, 2022
• First Submitted That Met QC Criteria: August 13, 2022
• First Posted (ACTUAL): August 16, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 13, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gallbladder Diseases; Biliary Tract Diseases; Emergencies; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: Still not known

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No