■短期和中期数据表明,腹腔镜Roux-en-Y胃旁路术(LRYGB)手术中肠系膜缺损的闭合降低了内疝合并小肠梗阻(SBO)的风险,但可能会增加术后早期空肠空肠吻合术的扭结风险。然而,根据我们的知识,没有临床试验报告该干预措施在SBO或阿片类药物使用风险方面的长期结果.
■评估LRYGB期间肠系膜缺损闭合的长期安全性和有效性结果。
■这项随机临床试验,平行,开放标签设计纳入了2010年5月1日至2011年11月14日在瑞典12个中心计划进行LRYGB减肥手术的重度肥胖患者,干预后随访10年.
■在操作过程中,患者以1:1的比例随机分配至空肠空肠造口术下方和Petersen间隙肠系膜缺损的封堵术,在LRYGB期间使用不可吸收的连续缝线或不封堵.
■主要结果是SBO的再次手术。新事件,慢性阿片类药物使用是衡量损害程度的次要终点.
■总共2507名患者(平均[SD]年龄,41.7[10.7]岁;1863名女性[74.3%])被随机分配到肠系膜缺损闭合(n=1259)或非闭合(n=1248)。在审查死亡和移民之后,对闭合组1193例患者(94.8%)和非闭合组1198例患者(96.0%)进行随访,直至研究结束。在10年的中位随访时间(IQR,10.0-10.0年),在手术后第31天至第10年的SBO再次手术中,有185例患者未闭合(10年累积发生率,14.9%;95%CI,13.0%-16.9%)和98例闭合患者(10年累积发生率,7.8%;95%CI,6.4%-9.4%)(亚风险比[SHR],0.42;95%CI,0.32-0.55)。在863名非封闭阿片类药物治疗患者中的175名中发现了新的慢性阿片类药物使用事件(10年累积发生率,20.4%;95%CI,17.7%-23.0%)和895例阿片类药物初治患者中的166例(10年累积发生率,18.7%;95%CI,16.2%-21.3%)(SHR,0.90;95%CI,0.73-1.11)。
■这项随机临床试验发现LRYGB肠系膜缺损闭合后SBO的风险长期降低。研究结果表明,应考虑在LRYGB期间常规使用此程序。
■ClinicalTrials.gov标识符:NCT01137201。
Short-term and midterm data suggest that mesenteric defects closure during laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery reduces the risk of internal herniation with small bowel obstruction (SBO) but may increase risk of kinking of the jejunojejunostomy in the early postoperative period. However, to our knowledge, there are no clinical trials reporting long-term results from this intervention in terms of risk for SBO or opioid use.
To evaluate long-term safety and efficacy outcomes of closure of mesenteric defects during LRYGB.
This randomized clinical
trial with a 2-arm, parallel, open-label design included patients with severe obesity scheduled for LRYGB bariatric surgery at 12 centers in Sweden from May 1, 2010, through November 14, 2011, with 10 years of follow-up after the intervention.
During the operation, patients were randomly assigned 1:1 to closure of mesenteric defects beneath the jejunojejunostomy and at the Petersen space using nonabsorbable running sutures during LRYGB or to nonclosure.
The primary outcome was reoperation for SBO. New incident, chronic opioid use was a secondary end point as a measure of harm.
A total of 2507 patients (mean [SD] age, 41.7 [10.7] years; 1863 female [74.3%]) were randomly assigned to closure of mesenteric defects (n = 1259) or nonclosure (n = 1248). After censoring for death and emigration, 1193 patients in the closure group (94.8%) and 1198 in the nonclosure group (96.0%) were followed up until the
study closed. Over a median follow-up of 10 years (IQR, 10.0-10.0 years), a reoperation for SBO from day 31 to 10 years after surgery was performed in 185 patients with nonclosure (10-year cumulative incidence, 14.9%; 95% CI, 13.0%-16.9%) and in 98 patients with closure (10-year cumulative incidence, 7.8%; 95% CI, 6.4%-9.4%) (subhazard ratio [SHR], 0.42; 95% CI, 0.32-0.55). New incident chronic opioid use was seen among 175 of 863 opioid-naive patients with nonclosure (10-year cumulative incidence, 20.4%; 95% CI, 17.7%-23.0%) and 166 of 895 opioid-naive patients with closure (10-year cumulative incidence, 18.7%; 95% CI, 16.2%-21.3%) (SHR, 0.90; 95% CI, 0.73-1.11).
This randomized clinical
trial found long-term reduced risk of SBO after mesenteric defects closure in LRYGB. The findings suggest that routine use of this procedure during LRYGB should be considered.
ClinicalTrials.gov Identifier: NCT01137201.