Department of Surgery, Vejle Hospital, University Hospital of Southern Denmark, DK-7100, Vejle, Denmark.
Colorectal Cancer Center South, Vejle Hospital, University Hospital of Southern Denmark, DK-7100, Vejle, Denmark.
World J Surg Oncol. 2019 Jul 22;17(1):127. doi: 10.1186/s12957-019-1668-7.
One third of patients with colorectal cancer (CRC) have comorbidity, which impairs their postoperative outcomes. Scoring systems may predict mortality, but there is limited evidence of effective interventions in high-risk patients. Our aim was to test a trial setup to assess the effect of extra postoperative medical visits and follow-up on 1-year mortality and other outcomes in patients with cardiopulmonary risk factors undergoing elective surgery for colorectal tumours.
Patients preoperatively screened positive for cardiopulmonary comorbidity were eligible. On postoperative day 4, they were randomised to either routine follow-up (RFU) or RFU with one extra medical visit and additional visits to the Cardiology and Respiratory Medicine Clinics 1 and 3 months postoperatively. The primary outcome measure was 1-year mortality; secondary outcome measures were length of stay (LOS), complications, and readmissions.
Of 673 screened patients 326 (48%) were found eligible, 108 declined participation, and 198 were randomised. Postoperative medical problems and/or need for intervention were found in 15-23% of the patients at the extra medical visits. The 90-day mortality was 0 and the 1-year mortality only 2.6% with no differences between the two groups. LOS and complication rates did not differ, but there were significantly fewer readmissions in the intervention group.
The 1-year mortality after elective CRC surgery was low, even in the presence of cardiopulmonary risk factors. There was no evidence of reduced mortality with additional medical follow-up in these patients.
ClinicalTrials.gov NCT02328365 registered 31 December 2014 (retrospectively registered).
三分之一的结直肠癌（CRC）患者存在合并症，这会影响他们的术后结果。评分系统可能预测死亡率，但针对高危患者的有效干预措施的证据有限。我们的目的是测试一种试验方案，以评估对有心肺危险因素的患者在接受结直肠肿瘤择期手术后进行额外术后医疗访问和随访对 1 年死亡率和其他结果的影响。
术前筛选出心肺合并症阳性的患者符合条件。术后第 4 天，他们被随机分配到常规随访（RFU）或 RFU 加一次额外的医疗访问，以及在术后 1、3 个月额外访问心脏病学和呼吸医学诊所。主要结局测量是 1 年死亡率；次要结局测量是住院时间（LOS）、并发症和再入院率。
在 673 名筛查患者中，有 326 名（48%）被发现符合条件，108 名拒绝参与，198 名被随机分配。在额外的医疗访问中，15-23%的患者出现术后医疗问题和/或需要干预。90 天死亡率为 0，1 年死亡率仅为 2.6%，两组之间无差异。LOS 和并发症发生率没有差异，但干预组的再入院率明显较低。
即使存在心肺危险因素，择期 CRC 手术后的 1 年死亡率也较低。在这些患者中，额外的医疗随访并没有降低死亡率的证据。
ClinicalTrials.gov NCT02328365 于 2014 年 12 月 31 日注册（回顾性注册）。
