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腹腔镜Heller肌切开术联合Dor胃底折叠术与Nissen胃底折叠术治疗贲门失弛缓症的随机对照试验:长期结果

Randomized controlled trial of laparoscopic Heller myotomy plus Dor fundoplication versus Nissen fundoplication for achalasia: long-term results.

作者信息

Rebecchi Fabrizio, Giaccone Claudio, Farinella Eleonora, Campaci Roberto, Morino Mario

机构信息

General Surgery and Center for Minimal Invasive Surgery, University of Turin, Turin, Italy.

出版信息

Ann Surg. 2008 Dec;248(6):1023-30. doi: 10.1097/SLA.0b013e318190a776.

Abstract

OBJECTIVES

To compare in a prospective, randomized trial the long-term results of laparoscopic Heller myotomy plus Dor fundoplication versus laparoscopic Heller myotomy plus floppy-Nissen for achalasia.

SUMMARY BACKGROUND DATA

Anterior fundoplication is usually performed after Heller myotomy to control GER; however, the incidence of postoperative GER ranges between 10% and 30%. Total fundoplication may aid in reducing GER rates.

METHODS

From December 1993 to September 2002, 153 patients with achalasia underwent Heller laparoscopic myotomy plus antireflux fundoplication. Of these, 9 were excluded from the study. The remaining 144 patients were randomly assigned to 2 treatment groups: Heller laparoscopic myotomy plus anterior fundoplication (Dor procedure) or Heller laparoscopic myotomy plus total fundoplication (floppy-Nissen procedure). The primary end point was incidence of clinical and instrumental GER after a minimum of 60 months follow-up. The secondary end point was recurrence of dysphagia. Follow-up clinical assessments were performed at 1, 3, 12, and 60 months using a modified DeMeester Symptom Scoring System (MDSS). Esophageal manometry and 24-hour pH monitoring were performed at 3, 12, and 60 months postoperative.

RESULTS

Of the 144 patients originally included in the study, 138 were available for long-term analysis: 71 (51%) underwent antireflux fundoplication plus a Dor procedure (H + D group) and 67 (49%) antireflux fundoplication plus a Nissen procedure (H + N group). No mortality was observed. The mean follow-up period was 125 months. No statistically significant differences in clinical (5.6% vs. 0%) or instrumental GER (2.8% vs. 0%) were found between the 2 groups; however, a statistically significant difference in dysphagia rates was noted (2.8% vs. 15%; P < 0.001).

CONCLUSIONS

Although both techniques achieved long-term GER control, the recurrence rate of dysphagia was significantly higher among the patients who underwent Nissen fundoplication. This evidence supports the use of Dor fundoplication as the preferred method to re-establish GER control in patients undergoing laparoscopic Heller myotomy.

摘要

目的

在一项前瞻性随机试验中,比较腹腔镜Heller肌切开术联合Dor胃底折叠术与腹腔镜Heller肌切开术联合松弛Nissen术治疗贲门失弛缓症的长期效果。

总结背景数据

Heller肌切开术后通常进行前胃底折叠术以控制胃食管反流(GER);然而,术后GER的发生率在10%至30%之间。全胃底折叠术可能有助于降低GER发生率。

方法

1993年12月至2002年9月,153例贲门失弛缓症患者接受了腹腔镜Heller肌切开术加抗反流胃底折叠术。其中9例被排除在研究之外。其余144例患者被随机分为2个治疗组:腹腔镜Heller肌切开术加前胃底折叠术(Dor手术)或腹腔镜Heller肌切开术加全胃底折叠术(松弛Nissen手术)。主要终点是至少随访60个月后的临床和器械性GER发生率。次要终点是吞咽困难的复发。使用改良的DeMeester症状评分系统(MDSS)在1、3、12和60个月进行随访临床评估。术后3、12和60个月进行食管测压和24小时pH监测。

结果

在最初纳入研究的144例患者中,138例可进行长期分析:71例(51%)接受了抗反流胃底折叠术加Dor手术(H+D组),67例(49%)接受了抗反流胃底折叠术加Nissen手术(H+N组)。未观察到死亡病例。平均随访期为125个月。两组之间在临床GER(5.6%对0%)或器械性GER(2.8%对0%)方面未发现统计学显著差异;然而,在吞咽困难发生率方面发现了统计学显著差异(2.8%对15%;P<0.001)。

结论

虽然两种技术都实现了长期GER控制,但接受Nissen胃底折叠术的患者吞咽困难复发率明显更高。这一证据支持将Dor胃底折叠术作为腹腔镜Heller肌切开术患者重新建立GER控制的首选方法。

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