Early Versus Interval Laparoscopic Cholecystectomy for Acute Cholecystitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Operative Time
研究概览
简要总结
This study compares two different timing approaches for gallbladder removal surgery in patients with acute gallbladder inflammation (acute cholecystitis).
When someone develops acute cholecystitis, doctors need to remove the gallbladder using a minimally invasive technique called laparoscopic surgery. However, there is ongoing debate about the best timing for this surgery. Some doctors prefer to operate early (within 3 days of diagnosis), while others prefer to wait and operate later (after 4 weeks of medical treatment).
In this study, we randomly assigned 166 patients with acute cholecystitis to receive either:
- Early surgery: Laparoscopic gallbladder removal within 72 hours of diagnosis
- Delayed surgery: Laparoscopic gallbladder removal after 4 weeks of antibiotic treatment
All surgeries were performed by the same experienced surgeon using standard techniques. We measured how long each surgery took, how many days patients stayed in the hospital, and how often the surgeon needed to switch from the minimally invasive approach to open surgery.
The study found that patients who had early surgery had shorter operation times, went home from the hospital sooner, and were less likely to need open surgery compared to patients who waited 4 weeks for their operation.
This research helps doctors and patients make better decisions about the timing of gallbladder surgery when someone has acute cholecystitis.
详细描述
This randomized controlled trial was designed to address the clinical question of optimal timing for laparoscopic cholecystectomy in acute cholecystitis, a condition affecting thousands of patients annually worldwide. The study was conducted in response to conflicting evidence and varying clinical practices regarding surgical timing.
Study Design and Setting:
The trial employed a parallel-group, single-blind randomized controlled design conducted at the General Surgery Department of Lady Reading Hospital, a tertiary care teaching hospital in Pakistan. The study period extended from May 1, 2024, to December 31, 2024, with comprehensive follow-up until patient discharge.
**Randomization and Blinding:** Participants were allocated using blocked randomization to ensure equal group sizes throughout the recruitment period. While complete blinding was not feasible due to the nature of the intervention, outcome assessors were blinded to group allocation during data collection. A computer-generated randomization sequence was used, with allocation concealment maintained through sealed opaque envelopes.
Intervention Protocols:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors collecting data on operative time, hospital stay, and conversion rates were blinded to group allocation. Complete blinding of participants and surgeons was not feasible due to the nature of the surgical timing intervention.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 20 and 60 years
- •Diagnosis of acute cholecystitis confirmed by history (right hypochondrial pain <5 days), clinical examination (tenderness in right hypochondrium), and ultrasound (thickened fibrosed gallbladder wall)
- •Presentation within 24 hours of symptom onset
- •ASA physical status class I or II
- •Provided written informed consent
排除标准
- •Patients with stones in the common bile duct on ultrasound
- •Patients with empyema of the gallbladder on ultrasound
- •Severe comorbidities (e.g., uncontrolled diabetes, ASA class III or higher)
- •Pregnancy
- •Previous upper abdominal surgery
- •Refusal to participate
结局指标
主要结局
Operative Time
时间窗: Intraoperatively (from anesthesia induction to closure of abdominal wall, assessed once during the surgery)
Operative time measured in minutes from anesthesia induction to complete closure of the abdominal wall, recorded using a standardized stopwatch protocol.
次要结局
- Length of Hospital Stay(Postoperatively (from end of surgery to discharge, assessed once at discharge))
- Conversion to Open Surgery(Intraoperatively (assessed during the surgical procedure))
研究者
Dr. Waseem Ullah
Registrar
Lady Reading Hospital, Pakistan