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经憩室炎发作后出现持续性和复发性症状时,手术治疗与保守治疗的长期疗效对比:一项多中心随机对照试验(DIRECT 试验)的 5 年随访结果。

Long-term Outcome of Surgery Versus Conservative Management for Recurrent and Ongoing Complaints After an Episode of Diverticulitis: 5-year Follow-up Results of a Multicenter Randomized Controlled Trial (DIRECT-Trial).

机构信息

Department of Surgery, Meander Medisch Centrum, Amersfoort, The Netherlands.

Department of Research Methodology, Measurement & Data Analysis, University of Twente, Enschede, The Netherlands.

出版信息

Ann Surg. 2019 Apr;269(4):612-620. doi: 10.1097/SLA.0000000000003033.

DOI:10.1097/SLA.0000000000003033
PMID:30247329
Abstract

OBJECTIVE

The aim of this study was to establish whether surgical or conservative treatment leads to a higher quality of life (QoL) in patients with recurring diverticulitis and/or ongoing complaints.

SUMMARY OF BACKGROUND DATA

The 6 months' results of the DIRECT trial, a randomized trial comparing elective sigmoidectomy with conservative management in patients with recurring diverticulitis (>2 episodes within 2 years) and/or ongoing complaints (>3 months) after an episode of diverticulitis, demonstrated a significantly higher QoL after elective sigmoidectomy. The aim of the present study was to evaluate QoL at 5-year follow-up.

METHODS

From January 2010 to June 2014, 109 patients were randomized to either elective sigmoidectomy (N = 53) or conservative management (N = 56). In the present study, the primary outcome was QoL measured by the Gastrointestinal Quality of Life Index (GIQLI) at 5-year follow-up. Secondary outcome measures were SF-36 score, Visual Analogue Score (VAS) pain score, EuroQol-5D-3L (EQ-5D-3L) score, morbidity, mortality, perioperative complications, and long-term operative outcome.

RESULTS

At 5-year follow-up, mean GIQLI score was significantly higher in the operative group [118.2 (SD 21.0)] than the conservative group [108.5 (SD 20.0)] with a mean difference of 9.7 (95% confidence interval 1.7-17.7). All secondary QoL outcome measures showed significantly better results in the operative group, with a higher SF-36 physical (P = 0.030) and mental score (P = 0.010), higher EQ5D score (P = 0.016), and a lower VAS pain score (P = 0.011). Twenty-six (46%) patients in the conservative group ultimately required surgery due to severe ongoing complaints. Of the operatively treated patients, 8 (11%) patients had anastomotic leakage and reinterventions were required in 11 (15%) patients.

CONCLUSION

Consistent with the short-term results of the DIRECT trial, elective sigmoidectomy resulted in a significantly increased QoL at 5-year follow-up compared with conservative management in patients with recurring diverticulitis and/or ongoing complaints. Surgeons should counsel these patients for elective sigmoidectomy weighing superior QoL, less pain, and lower risk of new recurrences against the complication risk of surgery.

摘要

目的

本研究旨在确定在患有复发性憩室炎和/或持续性症状的患者中,手术治疗与保守治疗哪种方法能带来更高的生活质量(QoL)。

背景资料概要

DIRECT 试验的 6 个月结果显示,与保守治疗相比,择期乙状结肠切除术可显著提高复发性憩室炎(2 年内发作超过 2 次)和/或憩室炎发作后持续存在症状(超过 3 个月)患者的 QoL。本研究旨在评估 5 年随访时的 QoL。

方法

2010 年 1 月至 2014 年 6 月,109 例患者被随机分配至择期乙状结肠切除术组(N=53)或保守治疗组(N=56)。本研究的主要结局指标是 5 年随访时采用胃肠道生活质量指数(GIQLI)评估的 QoL。次要结局指标包括 SF-36 评分、视觉模拟评分(VAS)疼痛评分、EuroQol-5D-3L(EQ-5D-3L)评分、发病率、死亡率、围手术期并发症和长期手术结果。

结果

5 年随访时,手术组的平均 GIQLI 评分[118.2(21.0)]显著高于保守组[108.5(20.0)],差值为 9.7(95%置信区间 1.7-17.7)。手术组的所有次要 QoL 结局指标均显著优于保守组,SF-36 身体评分(P=0.030)和精神评分(P=0.010)更高、EQ5D 评分(P=0.016)更高、VAS 疼痛评分(P=0.011)更低。保守组 26 例(46%)患者因严重持续性症状最终需要手术治疗。在接受手术治疗的患者中,8 例(11%)患者发生吻合口漏,11 例(15%)患者需要再次干预。

结论

与 DIRECT 试验的短期结果一致,与保守治疗相比,在患有复发性憩室炎和/或持续性症状的患者中,择期乙状结肠切除术可在 5 年随访时显著提高 QoL。外科医生应权衡手术治疗的 QoL 优势、更少的疼痛和更低的新发复发风险,与手术相关并发症风险,为这些患者提供择期乙状结肠切除术治疗的建议。

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