Gastroenterological Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland.
JAMA Surg. 2023 Jun 1;158(6):593-601. doi: 10.1001/jamasurg.2023.0466.
Both elective sigmoid resection and conservative treatment are options for patients with recurrent, complicated, or persistent painful diverticulitis; understanding outcomes following each can help inform decision-making.
To compare outcomes of elective sigmoid resection and conservative treatment for patients with recurrent, complicated, or persistent painful diverticulitis at 2-year follow-up.
DESIGN, SETTING, AND PARTICIPANTS: This multicenter parallel open-label individually randomized clinical trial comparing elective sigmoid resection to conservative treatment in patients with recurrent, complicated, or persistent painful diverticulitis was carried out in 5 Finnish hospitals between September 2014 and October 2018. Follow-up up to 2 years is reported. Of 85 patients randomized and included, 75 and 70 were available for QOL outcomes at 1 year and 2 years, respectively, and 79 and 78 were available for the recurrence outcome at 1 year and 2 years, respectively. The present analysis was conducted from September 2015 to June 2022.
Laparoscopic elective sigmoid resection vs conservative treatment (patient education and fiber supplementation).
Prespecified secondary outcomes included Gastrointestinal Quality of Life Index (GIQLI) score, complications, and recurrences within 2 years.
Ninety patients (28 male [31%]; mean [SD] age, 54.11 [11.9] years and 62 female [69%]; mean [SD] age, 57.13 [7.6] years) were randomized either to elective sigmoid resection or conservative treatment. After exclusions, 41 patients in the surgery group and 44 in the conservative group were included in the intention-to-treat analyses. Eight patients (18%) in the conservative treatment group underwent sigmoid resection within 2 years. The mean GIQLI score at 1 year was 9.51 points higher in the surgery group compared to the conservative group (mean [SD], 118.54 [17.95] vs 109.03 [19.32]; 95% CI, 0.83-18.18; P = .03), while the mean GIQLI score at 2 years was similar between the groups. Within 2 years, 25 of 41 patients in the conservative group (61%) had recurrent diverticulitis compared to 4 of 37 patients in the surgery group (11%). Four of 41 patients in the surgery group (10%) and 2 of 44 in the conservative group (5%) had major postoperative complications within 2 years. In per-protocol analyses, the mean (SD) GIQLI score was higher in the surgery group compared to the conservative treatment group by 11.27 points at 12 months (119.42 [17.98] vs 108.15 [19.28]; 95% CI, 2.24-20.29; P = .02) and 10.43 points at 24 months (117.24 [15.51] vs 106.82 [18.94]; 95% CI, 1.52-19.33; P = .02).
In this randomized clinical trial, elective sigmoid resection was effective in preventing recurrent diverticulitis and improved quality of life over conservative treatment within 2 years.
ClinicalTrials.gov Identifier: NCT02174926.
对于复发性、复杂性或持续性疼痛性憩室炎患者，选择性乙状结肠切除术和保守治疗都是选择；了解每种治疗方法的结果有助于做出决策。
比较复发性、复杂性或持续性疼痛性憩室炎患者接受选择性乙状结肠切除术和保守治疗的 2 年随访结果。
设计、地点和参与者：这项多中心平行开放标签个体随机临床试验比较了复发性、复杂性或持续性疼痛性憩室炎患者接受选择性乙状结肠切除术和保守治疗的结果，在芬兰的 5 家医院进行，时间为 2014 年 9 月至 2018 年 10 月。报告了 2 年的随访结果。85 名随机患者中，75 名和 70 名分别在 1 年和 2 年时可获得生活质量结局，79 名和 78 名分别在 1 年和 2 年时可获得复发结局。本分析于 2015 年 9 月至 2022 年 6 月进行。
腹腔镜下选择性乙状结肠切除术与保守治疗（患者教育和纤维补充）。
预先指定的次要结局包括胃肠道生活质量指数（GIQLI）评分、并发症和 2 年内复发。
90 名患者（28 名男性[31%]；平均[标准差]年龄为 54.11 [11.9]岁和 62 名女性[69%]；平均[标准差]年龄为 57.13 [7.6]岁）被随机分为乙状结肠切除术组或保守治疗组。排除后，手术组 41 例，保守治疗组 44 例纳入意向治疗分析。保守治疗组中有 8 例（18%）患者在 2 年内接受了乙状结肠切除术。与保守治疗组相比，手术组的平均 GIQLI 评分在 1 年时高 9.51 分（平均值[标准差]，118.54 [17.95] vs 109.03 [19.32]；95%置信区间，0.83-18.18；P=0.03），而 2 年时两组的平均 GIQLI 评分相似。在 2 年内，保守治疗组 41 例中有 25 例（61%）发生复发性憩室炎，手术组 37 例中有 4 例（11%）。手术组 41 例中有 4 例（10%）和保守治疗组 44 例中有 2 例（5%）发生重大术后并发症。在方案分析中，手术组的平均（标准差）GIQLI 评分在 12 个月时比保守治疗组高 11.27 分（119.42 [17.98] vs 108.15 [19.28]；95%置信区间，2.24-20.29；P=0.02），在 24 个月时高 10.43 分（117.24 [15.51] vs 106.82 [18.94]；95%置信区间，1.52-19.33；P=0.02）。
在这项随机临床试验中，与保守治疗相比，选择性乙状结肠切除术可有效预防复发性憩室炎，并在 2 年内改善生活质量。
ClinicalTrials.gov 标识符：NCT02174926。
