MINIMALLY INVASIVE LAPAROSCOPIC ESOPHAGECTOMY VS. TRANSHIATAL OPEN ESOPHAGECTOMY IN ACHALASIA: A RANDOMIZED STUDY

ABSTRACT Background: Open and laparoscopic trans-hiatal esophagectomy has been successfully performed in the treatment of megaesophagus. However, there are no randomized studies to differentiate them in their results. Aim: To compare the results of minimally invasive laparoscopic esophagectomy (EMIL) vs. open trans-hiatal esophagectomy (ETHA) in advanced megaesophagus. Method: A total of 30 patients were randomized, 15 of them in each group - EMIL and ETHA. The studied variables were dysphagia score before and after the operation at 24-months follow-up; pain score in the immediate postoperative period and at hospital discharge; complications of the procedure, comparing each group. Were also studied: surgical time in minutes, transfusion of blood products, length of hospital stay, mortality and follow-up time. Results: ETHA group comprised eight men and seven women; in the EMIL group, four women and 11 men. The median age in the ETHA group was 47.2 (29-68) years, and in the EMIL group of 44.13 (20-67) years. Mean follow-up time was 33 months, with one death in each group, both by fatal aspiration. There was no statistically significant difference between the EMIL vs. ETHA scores for dysphagia, pain and in-hospital complications. The same was true for surgical time, transfusion of blood products and hospital stay. Conclusion: There was no difference between EMIL and ETHA in all the studied variables, thus allowing them to be considered equivalent.

摘要：
背景：开放及腹腔镜经食管裂孔食管切除术已成功应用于巨食管症的治疗，但目前尚无随机对照研究对二者的临床疗效进行对比分析。
目的：对比微创腹腔镜食管切除术（minimally invasive laparoscopic esophagectomy, EMIL）与开放经食管裂孔食管切除术（open trans-hiatal esophagectomy, ETHA）治疗晚期巨食管症的临床效果。
方法：本研究共纳入30例患者，按1:1比例随机分为EMIL组与ETHA组，每组各15例。观察指标包括术前及术后24个月随访时的吞咽困难评分、术后即刻与出院时的疼痛评分、两组手术相关并发症情况；同时记录手术时长（分钟）、血液制品输注情况、住院时长、死亡率及总随访时长。
结果：ETHA组共8名男性、7名女性；EMIL组为11名男性、4名女性。ETHA组患者中位年龄为47.2岁（范围29~68岁），EMIL组为44.13岁（范围20~67岁）。本研究平均随访时长为33个月，两组各有1例患者因致命性误吸死亡。EMIL组与ETHA组在吞咽困难评分、疼痛评分及院内并发症发生率方面的组间差异均无统计学意义；手术时长、血液制品输注需求及住院时长的组间比较也未发现统计学差异。
结论：EMIL与ETHA在所有观察指标上均无显著差异，二者可被视为等效的治疗方案。