Evaluation of Post Operative Outcomes of Laparoscopic and Open Appendectomy in Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 166
- 主要终点
- Incidence of Surgical Site Infection (SSI)
研究概览
简要总结
Acute appendicitis is one of the most common surgical emergencies globally. While surgical removal of the appendix (appendectomy) is the definitive treatment, the optimal surgical approach-laparoscopic versus open-remains widely debated, particularly in obese patients. Obese individuals present unique surgical challenges due to increased abdominal wall thickness, which often necessitates larger skin incisions during open procedures, potentially increasing postoperative pain, wound healing times, and wound complications.
This study aims to compare the postoperative outcomes of laparoscopic appendectomy versus standard open appendectomy in obese patients (BMI ≥ 30 kg/m²) presenting with acute appendicitis. Participants will be randomly assigned to undergo either open appendectomy or laparoscopic appendectomy. The primary outcomes evaluated will be the incidence of surgical site infections (including superficial wound infections and intra-abdominal abscesses) up to 30 days post-procedure and the total length of hospital stay (in days).
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
- None
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese patients with Body Mass Index (BMI) ≥ 30 kg/m².
- •Clinical diagnosis of acute appendicitis based on Alvarado score (history of right lower quadrant or periumbilical pain shifting to RLQ, nausea and/or vomiting, fever > 38 °C, RLQ guarding and tenderness, and/or leukocytosis > 10,000 cells/mL).
- •Age between 15 and 50 years.
- •Both male and female patients.
排除标准
- •Immunocompromised patients (e.g., HIV infection or current steroid therapy).
- •History of prior chemotherapy, radiotherapy, or recurrent infections.
- •History of drug or alcohol abuse.
- •Severe hepatic, renal, or cardiovascular dysfunction.
- •History of previous abdominal surgery.
- •Appendicular malignancy.
- •Pregnant women.
- •Preoperative findings indicating appendiceal perforation.
研究组 & 干预措施
Open Appendectomy
Participants undergo open appendectomy using a standard grid-iron incision under general anesthesia. Appendiceal base ligation and closure are performed in standard anatomical layers.
干预措施: Open Appendectomy (Procedure)
Group 2: Laparoscopic Appendectomy
Participants undergo laparoscopic appendectomy using a standard 3-port technique (umbilical, left iliac fossa, and lower midline ports) under general anesthesia.
干预措施: Laparoscopic Appendectomy (Procedure)
结局指标
主要结局
Incidence of Surgical Site Infection (SSI)
时间窗: Up to 30 days postoperatively
Proportion of patients who develop a surgical site infection, defined as either superficial/deep wound infection (presence of purulent discharge, erythema, localized swelling, or requiring reopening) or intra-abdominal abscess (confirmed via ultrasound in patients presenting with abdominal pain, fever, or fullness)
Length of Hospital Stay
时间窗: From day of surgery up to discharge (up to 30 days postoperatively)
The total number of days the patient remained in the hospital postoperatively until meeting discharge criteria (afebrile, tolerating a regular diet, and achieving good pain control).
次要结局
未报告次要终点
研究者
Saira Khan
Principle Investigator
University of Health Sciences Lahore