择期手术切除与保守治疗后观察在伴有肠外气或脓肿的憩室炎初始治疗中的随机临床试验。

Randomized clinical trial of elective resection versus observation in diverticulitis with extraluminal air or abscess initially managed conservatively.

机构信息

Division of Colon and Rectal Surgery, State University of New York, Stony Brook, New York, USA.

出版信息

Br J Surg. 2018 Jul;105(8):971-979. doi: 10.1002/bjs.10868. Epub 2018 Apr 23.

DOI:10.1002/bjs.10868

PMID:29683483

Abstract

BACKGROUND

The aim of this RCT was to determine whether elective resection following successful non-operative management of a first episode of acute sigmoid diverticulitis complicated by extraluminal air with or without abscess is superior to observation in terms of recurrence rates.

METHODS

This was a single-centre, sequential design RCT. Patients were randomized to elective surgery or observation following non-operative management and colonoscopy. Non-operative management included nil by mouth, intravenous fluids, intravenous antibiotics, CT with intravenous contrast on arrival at hospital, and repeat CT with intravenous and rectal contrast on day 3 in hospital. The primary endpoint was recurrent diverticulitis at 24 months. Patients with a history of sigmoid diverticulitis, immunosuppression or peritonitis were not included.

RESULTS

Of 137 screened patients, 107 were assigned randomly to elective surgery (26) or observation (81), and underwent the allocated intervention after successful non-operative management. Conservative management failed in 15 patients. Groups were similar in age, sex, BMI, co-morbidities and colorectal POSSUM. Rates of recurrent diverticulitis differed significantly in the elective surgery and observation groups (8 versus 32 per cent; P = 0·019) at a mean(s.d.) follow-up of 37·8(8·6) and 35·2(9·2) months respectively. There was also a significant difference in time to recurrence (median 11 versus 7 months; P = 0·015). A total of 28 patients presented with recurrent diverticulitis complicated by extraluminal air and/or abscess (2 elective surgery, 26 observation), all of whom recovered with repeat non-operative management.

CONCLUSION

The majority of patients observed following conservative management of diverticulitis with local extraluminal air do not require elective surgery. Registration number: NCT01986686 (http://www.clinicaltrials.gov).

摘要

背景

本 RCT 的目的是确定对于首次因急性乙状结肠憩室炎并发管外气伴或不伴脓肿而接受非手术治疗成功的患者，与观察相比，选择性切除是否能降低复发率。

方法

这是一项单中心、连续设计 RCT。患者在非手术治疗和结肠镜检查后，随机分为选择性手术或观察组。非手术治疗包括禁食、静脉补液、静脉使用抗生素、入院时行静脉对比增强 CT 检查，以及入院第 3 天行静脉和直肠对比增强 CT 检查。主要终点是 24 个月时复发憩室炎。患有乙状结肠憩室炎、免疫抑制或腹膜炎病史的患者不包括在内。

结果

在 137 例筛选患者中，有 107 例被随机分配到选择性手术（26 例）或观察（81 例）组，并在成功的非手术治疗后接受了指定的干预措施。有 15 例患者的保守治疗失败。两组在年龄、性别、BMI、合并症和结直肠 POSSUM 方面相似。在平均（SD）随访 37.8（8.6）和 35.2（9.2）个月时，选择性手术组和观察组的复发憩室炎发生率差异显著（8%对 32%；P=0.019）。复发时间也有显著差异（中位数 11 对 7 个月；P=0.015）。共有 28 例患者出现复发憩室炎，伴有管外气和/或脓肿（2 例为选择性手术，26 例为观察组），所有患者均通过重复非手术治疗康复。