Abstract：
BACKGROUND: Retrospective research suggests that excision of the affected mesentery can improve outcomes after an ileocoecal resection in Crohn\'s disease. However, prospective data from randomised controlled trials are scarce. We aimed to compare rates of postoperative recurrence in patients with Crohn\'s disease who underwent extended mesenteric resection.
METHODS: This international, randomised controlled trial was done in six hospitals and tertiary care centres in the Netherlands and Italy. Eligible patients were aged 16 years or older and had Crohn\'s disease that was previously confirmed by endoscopy in the terminal ileum or ileocolic region (L1 or L3 disease), with an imaging update in the past 3 months (ultrasound, MRI, or CT enterography). Eligible patients were scheduled to undergo primary ileocolic resection with ileocolic anastomosis. Enrolled patients were assigned by use of simple random allocation (1:1) to either extended mesenteric resection (intervention) or conventional mesenteric sparing resection (control). The primary endpoint was endoscopic recurrence 6 months after surgery. Analyses were done in all patients with primary endpoint data, excluding those who had no anastomosis, a postoperative diagnosis other than Crohn\'s disease, or withdrew consent. This trial was registered with ClinicalTrials.gov, NCT04538638.
RESULTS: Between Feb 19, 2020, and April 24, 2023, we assessed 217 patients for eligibility. 78 patients were excluded due to failure to meet the inclusion criteria or refusal to participate. 139 patients were enrolled and randomly assigned to either extended mesenteric resection (n=71) or mesenteric sparing resection (n=68). All 139 patients underwent surgery. Six patients were excluded after random assignment due to withdrawal of consent (n=2), postoperative diagnosis other than Crohn\'s disease (n=2) and no anastomosis performed (in case of a stoma; n=2). Two patients were lost to follow-up, and two more patients deviated from the protocol by undergoing investigations other than endoscopy 6 months after. 133 patients were included in the baseline analysis (67 in the extended resection group and 66 in the sparing resection group) of whom 57 (43%) were male. Baseline characteristics were similar between the groups, and median patient age was 36 years (IQR 25-54). 131 patients were analysed for the primary outcome. There was no difference between groups in the rate of endoscopic recurrence at 6 months after surgery (28 [42%] of 66 patients in the extended mesenteric resection group vs 28 [43%] of 65 patients in the mesenteric sparing resection group, relative risk 0·985, 95% CI 0·663-1·464; p=1·0). Five (8%) of 66 patients in the extended mesenteric resection group had anastomotic leakage within the 30 days after surgery, as did one (2%) of 65 in the mesenteric sparing group. Postoperative complications of Clavien-Dindo grade IIIa or higher were reported in seven (11%) patients in the mesenteric resection group and five (8%) in the mesenteric sparing group.
CONCLUSIONS: Extended mesenteric resection was not superior to conventional resection with regard to endoscopic Crohn\'s disease recurrence. These data support the guideline-recommended mesenteric sparing approach.
BACKGROUND: Topconsortia voor Kennis en Innovatie-Topsector Life Sciences & Health.
METHODS: This international, randomised controlled trial was done in six hospitals and tertiary care centres in the Netherlands and Italy. Eligible patients were aged 16 years or older and had Crohn\'s disease that was previously confirmed by endoscopy in the terminal ileum or ileocolic region (L1 or L3 disease), with an imaging update in the past 3 months (ultrasound, MRI, or CT enterography). Eligible patients were scheduled to undergo primary ileocolic resection with ileocolic anastomosis. Enrolled patients were assigned by use of simple random allocation (1:1) to either extended mesenteric resection (intervention) or conventional mesenteric sparing resection (control). The primary endpoint was endoscopic recurrence 6 months after surgery. Analyses were done in all patients with primary endpoint data, excluding those who had no anastomosis, a postoperative diagnosis other than Crohn\'s disease, or withdrew consent. This trial was registered with ClinicalTrials.gov, NCT04538638.
RESULTS: Between Feb 19, 2020, and April 24, 2023, we assessed 217 patients for eligibility. 78 patients were excluded due to failure to meet the inclusion criteria or refusal to participate. 139 patients were enrolled and randomly assigned to either extended mesenteric resection (n=71) or mesenteric sparing resection (n=68). All 139 patients underwent surgery. Six patients were excluded after random assignment due to withdrawal of consent (n=2), postoperative diagnosis other than Crohn\'s disease (n=2) and no anastomosis performed (in case of a stoma; n=2). Two patients were lost to follow-up, and two more patients deviated from the protocol by undergoing investigations other than endoscopy 6 months after. 133 patients were included in the baseline analysis (67 in the extended resection group and 66 in the sparing resection group) of whom 57 (43%) were male. Baseline characteristics were similar between the groups, and median patient age was 36 years (IQR 25-54). 131 patients were analysed for the primary outcome. There was no difference between groups in the rate of endoscopic recurrence at 6 months after surgery (28 [42%] of 66 patients in the extended mesenteric resection group vs 28 [43%] of 65 patients in the mesenteric sparing resection group, relative risk 0·985, 95% CI 0·663-1·464; p=1·0). Five (8%) of 66 patients in the extended mesenteric resection group had anastomotic leakage within the 30 days after surgery, as did one (2%) of 65 in the mesenteric sparing group. Postoperative complications of Clavien-Dindo grade IIIa or higher were reported in seven (11%) patients in the mesenteric resection group and five (8%) in the mesenteric sparing group.
CONCLUSIONS: Extended mesenteric resection was not superior to conventional resection with regard to endoscopic Crohn\'s disease recurrence. These data support the guideline-recommended mesenteric sparing approach.
BACKGROUND: Topconsortia voor Kennis en Innovatie-Topsector Life Sciences & Health.
摘要：
背景：回顾性研究表明，切除受影响的肠系膜可以改善克罗恩病回肠切除后的预后。然而,随机对照试验的前瞻性数据很少.我们旨在比较接受扩大肠系膜切除术的克罗恩病患者的术后复发率。
方法：这个国际，在荷兰和意大利的6家医院和三级医疗中心进行了随机对照试验.符合条件的患者年龄在16岁或以上，患有克罗恩病，先前在回肠末端或回肠结肠区域通过内窥镜检查证实（L1或L3疾病），过去3个月的影像学更新(超声波，MRI,或CT小肠造影)。符合条件的患者被安排进行原发性回肠切除术和回肠吻合术。通过简单随机分配（1：1）将纳入的患者分配给延长肠系膜切除术（干预）或常规肠系膜保留切除术（对照）。主要终点为术后6个月内镜下复发。对所有具有主要终点数据的患者进行了分析，不包括那些没有吻合的人，除克罗恩病以外的术后诊断，或撤回同意。该试验已在ClinicalTrials.gov注册，NCT04538638。
结果：在2020年2月19日至2023年4月24日之间，我们评估了217名患者的资格。78例患者因未达到纳入标准或拒绝参加而被排除。139例患者被纳入并随机分配至延长肠系膜切除术（n=71）或保留肠系膜切除术（n=68）。139例患者均接受手术治疗。6例患者在随机分配后由于撤回同意而被排除（n=2），术后诊断为克罗恩病（n=2），未进行吻合（在造口的情况下；n=2）。两名患者失去了随访，另有两名患者在6个月后接受内镜检查以外的其他检查，从而偏离了治疗方案。基线分析中纳入了133例患者（扩大切除组67例，保留切除组66例），其中57例（43％）为男性。两组的基线特征相似，患者年龄中位数为36岁(IQR25-54).分析了131例患者的主要结果。术后6个月内镜下复发率组间无差异(肠系膜扩大切除组66例患者中28例[42%]vs肠系膜保留切除组65例患者中28例[43%],相对风险0.985，95%CI0.663-1·464；p=1·0)。扩大肠系膜切除术组66例患者中有5例(8%)在术后30天内出现吻合口漏,肠系膜保留组65个中的一个（2％）。据报道，肠系膜切除组7例（11％）患者和肠系膜保留组5例（8％）患者出现Clavien-DindoIIIa级或更高的术后并发症。
结论：在内镜下克罗恩病复发方面，扩大肠系膜切除术并不优于常规切除术。这些数据支持指南推荐的肠系膜保留方法。
背景：TopconsortiavorKennisenInnovatie-Topsector生命科学与健康。
方法：这个国际，在荷兰和意大利的6家医院和三级医疗中心进行了随机对照试验.符合条件的患者年龄在16岁或以上，患有克罗恩病，先前在回肠末端或回肠结肠区域通过内窥镜检查证实（L1或L3疾病），过去3个月的影像学更新(超声波，MRI,或CT小肠造影)。符合条件的患者被安排进行原发性回肠切除术和回肠吻合术。通过简单随机分配（1：1）将纳入的患者分配给延长肠系膜切除术（干预）或常规肠系膜保留切除术（对照）。主要终点为术后6个月内镜下复发。对所有具有主要终点数据的患者进行了分析，不包括那些没有吻合的人，除克罗恩病以外的术后诊断，或撤回同意。该试验已在ClinicalTrials.gov注册，NCT04538638。
结果：在2020年2月19日至2023年4月24日之间，我们评估了217名患者的资格。78例患者因未达到纳入标准或拒绝参加而被排除。139例患者被纳入并随机分配至延长肠系膜切除术（n=71）或保留肠系膜切除术（n=68）。139例患者均接受手术治疗。6例患者在随机分配后由于撤回同意而被排除（n=2），术后诊断为克罗恩病（n=2），未进行吻合（在造口的情况下；n=2）。两名患者失去了随访，另有两名患者在6个月后接受内镜检查以外的其他检查，从而偏离了治疗方案。基线分析中纳入了133例患者（扩大切除组67例，保留切除组66例），其中57例（43％）为男性。两组的基线特征相似，患者年龄中位数为36岁(IQR25-54).分析了131例患者的主要结果。术后6个月内镜下复发率组间无差异(肠系膜扩大切除组66例患者中28例[42%]vs肠系膜保留切除组65例患者中28例[43%],相对风险0.985，95%CI0.663-1·464；p=1·0)。扩大肠系膜切除术组66例患者中有5例(8%)在术后30天内出现吻合口漏,肠系膜保留组65个中的一个（2％）。据报道，肠系膜切除组7例（11％）患者和肠系膜保留组5例（8％）患者出现Clavien-DindoIIIa级或更高的术后并发症。
结论：在内镜下克罗恩病复发方面，扩大肠系膜切除术并不优于常规切除术。这些数据支持指南推荐的肠系膜保留方法。
背景：TopconsortiavorKennisenInnovatie-Topsector生命科学与健康。
