腹腔镜与开腹上消化道溃疡穿孔修补术的随机对照研究

A prospective randomized controlled trial of laparoscopic repair versus open repair for perforated peptic ulcers

目的 比较腹腔镜与开腹上消化道溃疡穿孔修补术的临床疗效。方法 前瞻性纳入2010年1月至2014年6月上海市同济大学附属同济医院普通外科119例临床诊断为上消化道溃疡穿孔准备接受手术治疗患者，按计算机产生随机数字的方法，分为腹腔镜组（58例）和开腹组（61例），比较两组患者的术中及术后指标。本研究经中国临床试验注册中心注册为随机对照研究，注册号为ChiCTR-TRC-11001607。结果 两组基线资料的比较，差异无统计学意义（P 〉 0.05）。两组患者手术时间、术后并发症发生率、病死率、再次手术率、胃肠减压时间、恢复流质饮食时间及总住院费用的差异无统计学意义（P 〉 0.05）。与开腹组比较，腹腔镜组术后芬太尼的用量较少[（0.74 ± 0.33）mg比（1.04 ± 0.39）mg，t= -4.519，P= 0.000]，总住院时间较短[中位数7 d比8 d，U=-2.090，P= 0.001]。腹腔镜组有3例（5.2%）术后出现穿孔部位瘘，其中1例腹腔镜患者在术后第2天因弥漫性腹膜炎行开腹手术治疗，另外2例则行保守治疗（包括全胃肠外营养和肠内营养）；开腹组无术后穿孔部位瘘的发生。两组均有1例患者在术后第22天死于多脏器功能障碍综合征（MODS）。结论 腹腔镜修补术治疗上消化道溃疡穿孔具有一定优势，但要注意防止出现修补部位瘘。

Objective To compared the clinical efficacy of laparoscopic repair （LR） versus open repair （OR） for perforated peptic ulcers. Methods From January 2010 to June 2014, in Shanghai Tongji Hospital, 119 patients who were diagnosed as perforated peptic ulcers and planned to receive operation were prospectively enrolled. Patients were randomly divided into LR （58 patients） and OR （61 patients） group by computer. Intra-operative and postoperative parameters were compared between two groups. This study was registered as a randomized controlled trial by the China Clinical Trials Registry （registration No.ChiCTR-TRC-11001607） . Results There was no significant difference in baseline data between two groups （all P 〉 0.05） . No significant differences of operation time, morbidity of postoperative complication, mortality, reoperation probability, decompression time, fluid diet recovery time and hospitalization cost were found between two groups （all P 〉 0.05） . As compared to OR group, LR group required less postoperative fentanyl[ （0.74 ± 0.33） mg vs. （1.04 ± 0.39） mg, t= -4.519, P= 0.000] and had shorter hospital stay [median 7 （5 to 9） days vs. 8 （7 to 10） days, U=-2.090, P= 0.001]. In LR group, 3 patients （5.2%） had leakage in perforation site after surgery. One case received laparotomy on the second day after surgery for diffuse peritonitis. The other two received conservative treatment （total parenteral nutrition and enteral nutrition） . There was no recurrence of perforation in OR group. One patient of each group died of multiple organ dysfunction syndrome （MODS） 22 days after surgery. Conclusion LR may be preferable for treating perforated peptic ulcers than OR, however preventive measures during LR should be taken to avoid postopertive leak in perforation site.