Petro Clayton C, Ellis Ryan C, Maskal Sara M, Zolin Sam J, Tu Chao, Costanzo Adele, Beffa Lucas R A, Krpata David M, Alaedeen Diya, Prabhu Ajita S, Miller Benjamin T, Baier Kevin F, Fathalizadeh Alisan, Rodriguez John, Rosen Michael J
Cleveland Clinic Center for Abdominal Core Health, Department of General Surgery, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, Cleveland, Ohio.
Division of Minimally Invasive and Bariatric Surgery, Department of Surgery, Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania.
JAMA Surg. 2025 Mar 1;160(3):247-255. doi: 10.1001/jamasurg.2024.5788.
Paraesophageal hernias can cause severe limitations in quality of life and life-threatening complications. Even though minimally invasive paraesophageal hernia repair (MIS-PEHR) is safe and effective, anatomic recurrence rates remain notoriously high. Retrospective data suggest that suturing the stomach to the anterior abdominal wall after repair-an anterior gastropexy-may reduce recurrence, but this adjunct is currently not the standard of care.
To determine whether anterior gastropexy reduces 1-year recurrence after MIS-PEHR.
DESIGN, SETTING, AND PARTICIPANTS: This registry-based randomized clinical trial was conducted by 10 surgeons at 3 academic hospitals within the Cleveland Clinic Enterprise. Between June 26, 2019, and July 24, 2023, 348 patients were assessed for eligibility, and 240 patients were enrolled and randomized. Statistical analysis was performed from January to March 2024.
Enrolled patients were randomized to and received either an anterior gastropexy (n = 119) or no anterior gastropexy (n = 121).
The primary outcome was recurrence as determined by reherniation of the stomach greater than 2 cm above the diaphragm on routine imaging at 1 year or reoperation. Secondary outcomes included quality of life as measured by the Gastroesophageal Reflux Health-Related Quality of Life survey, additional foregut symptom questionnaire, and patient satisfaction at 30 days and 1 year.
A total of 240 patients were randomized to either anterior gastropexy (n = 119; 104 [97%] women; median [IQR] age, 70 [64-75] years) or no anterior gastropexy (n = 121; 97 [80%] women; median [IQR] age, 68 [62-73] years) at the end of their MIS-PEHR. At 1 year, 188 patients (78%) had completed follow-up. By intention-to-treat analysis, 1-year recurrence was significantly lower in patients who received an anterior gastropexy (15% vs 36%; risk difference, 0.21 [95% CI, 0.09-0.33]), which remained significant after risk-adjusted regression analysis (hazard ratio, 0.38 [95% CI, 0.23-0.60]). Of 13 reoperations (5.4%) for recurrence in the first year, 3 (2.5%) were in the anterior gastropexy group and 10 (8.2%) were in the no-gastropexy group (P = .052). Two patients (1.7%) had their anterior gastropexy sutures removed for pain. There were no significant differences in quality-of-life outcomes at 30 days and 1 year between treatment groups.
This randomized clinical trial found that the addition of an anterior gastropexy to MIS-PEHR is superior to no gastropexy in regard to reducing 1-year paraesophageal hernia recurrence. These results suggest that an anterior gastropexy should be routinely used in the context of minimally invasive paraesophageal hernia repair.
ClinicalTrials.gov Identifier: NCT04007952.
食管旁疝可导致生活质量严重受限并引发危及生命的并发症。尽管微创食管旁疝修补术（MIS - PEHR）安全有效，但解剖学复发率仍然居高不下。回顾性数据表明，修补术后将胃缝合至前腹壁——即前胃固定术——可能会降低复发率，但目前这种辅助手段并非标准治疗方法。
确定前胃固定术是否能降低MIS - PEHR术后1年的复发率。
设计、设置和参与者：这项基于注册登记的随机临床试验由克利夫兰诊所企业旗下3家学术医院的10名外科医生进行。在2019年6月26日至2023年7月24日期间，对348例患者进行了资格评估，240例患者入组并随机分组。于2024年1月至3月进行统计分析。
入组患者被随机分配并接受前胃固定术（n = 119）或不接受前胃固定术（n = 121）。
主要结局是通过1年时常规影像学检查发现胃在膈肌上方2 cm以上再次疝出或再次手术确定的复发情况。次要结局包括通过胃食管反流健康相关生活质量调查问卷、额外的前肠症状问卷以及30天和1年时的患者满意度来衡量的生活质量。
共有240例患者在完成MIS - PEHR后被随机分配接受前胃固定术（n = 119；104例[97%]为女性；年龄中位数[四分位间距]，70岁[64 - 75岁]）或不接受前胃固定术（n = 121；97例[80%]为女性；年龄中位数[四分位间距]，68岁[62 - 73岁]）。1年时，188例患者（78%）完成了随访。按意向性分析，接受前胃固定术的患者1年复发率显著更低（15%对36%；风险差异，0.21[95%置信区间，0.09 - 0.33]），在风险调整回归分析后仍具有显著性（风险比，0.38[95%置信区间，0.23 - 0.60]）。在第一年因复发进行的13例再次手术（5.4%）中，3例（2.5%）在前胃固定术组，10例（8.2%）在未行胃固定术组（P = 0.052）。2例患者（1.7%）因疼痛拆除了前胃固定术缝线。治疗组之间在30天和1年时的生活质量结局无显著差异。
这项随机临床试验发现，在MIS - PEHR中增加前胃固定术在降低食管旁疝1年复发率方面优于不进行胃固定术。这些结果表明，在前胃固定术应常规用于微创食管旁疝修补术中。
ClinicalTrials.gov标识符：NCT04007952
