Early Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis

Sana'a University81 enrolled

Overview

The goal of this clinical trial is to learn if performing gallbladder surgery early is as safe and effective as delaying it for people with acute cholecystitis (a sudden gallbladder infection). The main questions it aims to answer are: * Do participants who have early surgery have a similar rate of complications compared to those who have delayed surgery? * How does the timing of surgery affect the length of the hospital stay? Researchers will compare two groups: 1. An early surgery group 2. A delayed surgery group Participants in the early surgery group had their gallbladder removed within 72 hours of when their symptoms started. Participants in the delayed surgery group were first treated with medications and had their surgery 6-8 weeks later.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Cholecystitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Yemeni nationals aged 18-70 years * A clinical diagnosis of acute cholecystitis confirmed by clinical presentation, laboratory findings, and imaging studies * Symptom duration of less than 72 hours at presentation * Fitness for general anesthesia (American Society of Anesthesiologists \[ASA\] physical status classification I-III) * Provision of written informed consent Exclusion Criteria: * Evidence of choledocholithiasis or acute cholangitis * Severe comorbidities precluding surgery (ASA class IV-V) * Coagulopathy (INR \>1.5 or platelet count \<100,000/μL) * Pregnancy * Previous major upper abdominal surgery * Patient refusal to participate

Outcomes

Primary Outcomes

Overall Postoperative Complications

Incidence of any postoperative complication within 30 days

Time frame: Within 30 days post-surgery

Conversion to Open Surgery

Rate of conversion from laparoscopic to open cholecystectomy during the procedure.

Time frame: Intraoperative

Operative Time

Duration of surgery, measured in minutes from skin incision to skin closure.

Time frame: Intraoperative

Secondary Outcomes

Postoperative Length of Hospital Stay

Number of days from surgery to hospital discharge.

Time frame: Up to 30 days post-surgery

Duration of Postoperative Pain

Number of days from surgery until the participant was free of the need for analgesic medication.

Time frame: Up to 30 days post-surgery

Time to Return to Normal Daily Activities

Number of days from surgery until the participant reported a full return to normal daily activities.

Time frame: Up to 30 days post-surgery

30-Day Readmission Rate

Rate of unplanned hospital readmission for any cause within 30 days of discharge.

Time frame: 30 days

Early Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes