Practical Advantages of Single-port Over Conventional Three-port Laparoscopic Appendectomy in Children: A Randomized Controlled Trial of 400 Cases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Post-operative pain (visual analogue scale of pain ranging 0-10)
研究概览
简要总结
Despite growing popularity, practical advantages of single-port laparoscopic appendectomy (SLA) over conventional three-port laparoscopic appendectomy (CLA) have yet to be established well in pediatric population.
The investigators designed the randomized controlled trial to clarify practical advantages of SLA over CLA in pediatric population. The investigators compared conversion rate, intra-operative adverse events, operating time, wound complications, intra-abdominal complications, and postoperative hospital stay, changes in postoperative pain severity, and cosmetic outcomes during follow up period between SLA and CLA groups.
详细描述
Currently the single-port laparoscopic appendectomy (SLA) has gained popularity in pediatric population since it was first reported in 1998 by Esposito et al. Nonetheless, the practical advantages of SLA over conventional three-port laparoscopic appendectomy (CLA) have yet to be established well in pediatric population due to lacking and inconsistent high-level evidences from randomized trials and meta-analysis.
Thus far, in addition to overall postoperative hospital stay, complications such as wound abscess and seroma, intra-abdominal abscess and ileus were reported not to be significantly different between SLA and CLA, while SLA might have taken longer operation time in children and adult. Currently, the advertised benefits on postoperative pain and cosmetic results of SLA incurred suspicion because of heterogeneous data inconsistently supporting SLA from a few RCTs especially in pediatric population. Consequently, a consensus regarding the practical superiority of SLA to CLA has still not been reached particularly in children.
To address this issue, the investigators designed the randomized trial to clarify practical benefits of SLA over CLA in pediatric population. For this, the investigators compared conversion rate, intra-operative adverse events, operating time, wound complications, intra-abdominal complications, and postoperative hospital stay, changes in postoperative pain severity, and cosmetic outcomes during follow up period between SLA and CLA groups. Primary end points were postoperative pain severity and cosmetic satisfaction. Secondary endpoints were intra- and post-operative complication rates, operation time, and postoperative hospital stay.
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
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute appendicitis was diagnosed in accordance with following clinical, laboratory, and radiographic criteria; history of right lower quadrant pain or periumbilical pain migrating to the right lower quadrant with nausea and/or vomiting. presence direct and indirect tenderness on McBurney's point and/or right lower quadrant guarding. a fever ≥ 38°C and/or white blood cell counts more than 10X10³ cells per mL on complete blood count. diameter of appendix ≥ 6 mm with mural thickening and periappendiceal fat infiltration and/or abdominal fluid collection on appendiceal ultrasonography or abdominopelvic computed tomography.
- •Perforated appendicitis: disrupted appendix contour with non-homogenous peritoneal fluid collection in pelvic cavity and/or sub-hepatic space simultaneously with above mentioned clinical, laboratory, and radiographic findings of appendicitis.
- •Peri-appendiceal abscess which was preoperatively confirmed by ultrasonographic and/or computed tomographic evidence.
排除标准
- •Suspicious diagnosis of appendicitis which was not in accordance with the diagnosis criteria.
- •Patients who were subjected to ≥ 2 days of empirical antibiotics therapy for initial symptom prior to diagnosis with acute appendicitis.
- •History of coagulation disorders, shock upon admission, previous abdominal surgery, contraindication to general anesthesia, suspected or proven malignancy, and mental illness.
结局指标
主要结局
Post-operative pain (visual analogue scale of pain ranging 0-10)
时间窗: up to postoperative day 7
Post-operative pain is measured by visual analogue scale of pain ranging 0-10.
Cosmetic satisfaction (visual analogue scale of cosmetic result ranging 1-10)
时间窗: at postoperative 12 months
Cosmetic satisfaction is measured by visual analogue scale of cosmetic result ranging 1-10.
次要结局
- Operation time(on postoperative day 1)
- Post-operative hospital stay(at postoperative 2 weeks)
- Wound complications(up to postoperative 3 months)
- Intra-abdominal complications(up to postoperative 3 months)