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腹腔镜冲洗与原发性切除术治疗急性穿孔性憩室炎:来自斯堪的纳维亚憩室炎(SCANDIV)随机临床试验的长期结果。

Laparoscopic Lavage vs Primary Resection for Acute Perforated Diverticulitis: Long-term Outcomes From the Scandinavian Diverticulitis (SCANDIV) Randomized Clinical Trial.

机构信息

Department of Surgery, Skåne University Hospital, Malmö, Sweden.

Department of Clinical Sciences Malmö, Lund University, Lund, Sweden.

出版信息

JAMA Surg. 2021 Feb 1;156(2):121-127. doi: 10.1001/jamasurg.2020.5618.

Abstract

IMPORTANCE

Perforated colonic diverticulitis usually requires surgical resection, with significant morbidity. Short-term results from randomized clinical trials have indicated that laparoscopic lavage is a feasible alternative to resection. However, it appears that no long-term results are available.

OBJECTIVE

To compare long-term (5-year) outcomes of laparoscopic peritoneal lavage and primary resection as treatments of perforated purulent diverticulitis.

DESIGN, SETTING, AND PARTICIPANTS: This international multicenter randomized clinical trial was conducted in 21 hospitals in Sweden and Norway, which enrolled patients between February 2010 and June 2014. Long-term follow-up was conducted between March 2018 and November 2019. Patients with symptoms of left-sided acute perforated diverticulitis, indicating urgent surgical need and computed tomography-verified free air, were eligible. Those available for trial intervention (Hinchey stages <IV) were included in the long-term follow-up.

INTERVENTIONS

Patients were assigned to undergo laparoscopic peritoneal lavage or colon resection based on computer-generated, center-stratified block randomization.

MAIN OUTCOMES AND MEASURES

The primary outcome was severe complications within 5 years. Secondary outcomes included mortality, secondary operations, recurrences, stomas, functional outcomes, and quality of life.

RESULTS

Of 199 randomized patients, 101 were assigned to undergo laparoscopic peritoneal lavage and 98 were assigned to colon resection. At the time of surgery, perforated purulent diverticulitis was confirmed in 145 patients randomized to lavage (n = 74) and resection (n = 71). The median follow-up was 59 (interquartile range, 51-78; full range, 0-110) months, and 3 patients were lost to follow-up, leaving a final analysis of 73 patients who had had laparoscopic lavage (mean [SD] age, 66.4 [13] years; 39 men [53%]) and 69 who had received a resection (mean [SD] age, 63.5 [14] years; 36 men [52%]). Severe complications occurred in 36% (n = 26) in the laparoscopic lavage group and 35% (n = 24) in the resection group (P = .92). Overall mortality was 32% (n = 23) in the laparoscopic lavage group and 25% (n = 17) in the resection group (P = .36). The stoma prevalence was 8% (n = 4) in the laparoscopic lavage group vs 33% (n = 17; P = .002) in the resection group among patients who remained alive, and secondary operations, including stoma reversal, were performed in 36% (n = 26) vs 35% (n = 24; P = .92), respectively. Recurrence of diverticulitis was higher following laparoscopic lavage (21% [n = 15] vs 4% [n = 3]; P = .004). In the laparoscopic lavage group, 30% (n = 21) underwent a sigmoid resection. There were no significant differences in the EuroQoL-5D questionnaire or Cleveland Global Quality of Life scores between the groups.

CONCLUSIONS AND RELEVANCE

Long-term follow-up showed no differences in severe complications. Recurrence of diverticulitis after laparoscopic lavage was more common, often leading to sigmoid resection. This must be weighed against the lower stoma prevalence in this group. Shared decision-making considering both short-term and long-term consequences is encouraged.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT01047462.

摘要

重要提示

通常情况下,穿孔性结肠憩室炎需要进行手术切除,且术后并发症发生率较高。随机临床试验的短期结果表明,腹腔镜灌洗是一种可行的替代手术切除的方法。然而,目前似乎还没有长期结果。

目的

比较腹腔镜腹膜灌洗与原发性切除术治疗穿孔性化脓性憩室炎的长期(5 年)结果。

设计、地点和参与者:本国际多中心随机临床试验在瑞典和挪威的 21 家医院进行,于 2010 年 2 月至 2014 年 6 月期间招募患者。2018 年 3 月至 2019 年 11 月期间进行了长期随访。符合条件的患者为有左侧急性穿孔性憩室炎症状(提示有紧急手术需求和 CT 证实有游离气)的患者。接受试验干预(Hinchey 分期 <IV)的患者被纳入长期随访。

干预措施

根据计算机生成的、中心分层的随机分组,患者被分配接受腹腔镜腹膜灌洗或结肠切除术。

主要结局和测量指标

主要结局是 5 年内发生严重并发症。次要结局包括死亡率、二次手术、复发、造口、功能结局和生活质量。

结果

在 199 名随机分组的患者中,101 名患者被分配接受腹腔镜腹膜灌洗,98 名患者被分配接受结肠切除术。在手术时,随机分组至灌洗组(n = 74)和切除术组(n = 71)的 145 名患者中,均确诊为穿孔性化脓性憩室炎。中位随访时间为 59 个月(四分位距,51-78;全距,0-110),3 名患者失访,最终分析了 73 名接受腹腔镜灌洗的患者(平均年龄[标准差],66.4 [13]岁;39 名男性[53%])和 69 名接受结肠切除术的患者(平均年龄[标准差],63.5 [14]岁;36 名男性[52%])。腹腔镜灌洗组 36%(n = 26)的患者发生严重并发症,切除术组 35%(n = 24)的患者发生严重并发症(P = .92)。腹腔镜灌洗组的总体死亡率为 32%(n = 23),切除术组为 25%(n = 17)(P = .36)。在仍然存活的患者中,腹腔镜灌洗组的造口发生率为 8%(n = 4),切除术组为 33%(n = 17;P = .002),二次手术(包括造口反转)分别为 36%(n = 26)和 35%(n = 24)(P = .92)。腹腔镜灌洗组的憩室炎复发率更高(21%[n = 15]比 4%[n = 3];P = .004)。在腹腔镜灌洗组中,30%(n = 21)的患者接受了乙状结肠切除术。两组之间的 EuroQoL-5D 问卷或克利夫兰全球生活质量评分均无显著差异。

结论和相关性

长期随访结果显示严重并发症无差异。腹腔镜灌洗后憩室炎复发更常见,常导致乙状结肠切除术。这必须与该组较低的造口发生率相权衡。鼓励进行考虑短期和长期后果的共同决策。

试验注册

ClinicalTrials.gov 标识符:NCT01047462。

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