单孔腹腔镜与传统腹腔镜结直肠癌手术的肿瘤学结局比较（CSILS）：一项多中心、前瞻性、开放标签、非劣效性、随机对照临床试验研究方案。
Oncologic outcomes of single-incision laparoscopic surgery versus conventional laparoscopic surgery for colorectal cancer (CSILS): study protocol for a multicentre, prospective, open-label, noninferiority, randomized controlled trial.
机构信息
Department of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197, Ruijin Er Road, Huangpu District, Shanghai, 200025, China.
Department of Biostatistics and Clinical Research Center, Shanghai Jiao Tong University School of Medicine, No. 227, South Chongqing Road, Huangpu District, Shanghai, 200025, China.
出版信息
BMC Cancer. 2022 Jul 7;22(1):743. doi: 10.1186/s12885-022-09821-9.
BACKGROUND
In most previous studies, single-incision laparoscopic surgery (SILS) for colorectal cancer (CRC) was feasible and safe in the short term. However, long-term oncologic outcomes remain uncertain, as only a few studies contained long-term survival data. SILS for CRC is still in the early stages of research. Further studies, particularly large-scale, prospective randomized controlled trials, are necessary to assess the value of SILS for CRC.
METHODS
This study is a prospective, multicentre, open-label, noninferiority, parallel-group randomized controlled trial that investigates the long-term oncologic outcomes of SILS compared to conventional laparoscopic surgery (CLS) for CRC. A total of 710 eligible patients will be randomly assigned to the SILS group or the CLS group at a 1:1 ratio using a central, dynamic, and stratified block randomization method. Patients with ages ranging from 18 to 85 years old, of both sexes, with CRC above the peritoneal reflection diagnosed as cT1-4aN0-2M0 and a tumour size no larger than 5 cm will be considered for the study. The primary endpoint is 3-year disease-free survival (DFS). The secondary endpoints include: intraoperative outcomes, postoperative recovery, postoperative pain assessment, pathological outcomes, early morbidity and mortality rate, cosmetic effects, quality of life, 3-year overall survival (OS), incidence of incisional hernia, 5-year DFS and 5-year OS. The first two follow-up visits will be scheduled at one month and three months postoperatively, then every three months for the first two years and every six months for the next three years.
DISCUSSION
Currently, no randomized controlled trials (RCTs) have been designed to investigate the long-term oncologic outcomes of SILS for CRC. This study is expected to provide clinical evidence of the oncologic outcomes of SILS compared to CLS for CRC to promote its widespread use.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT04527861 (registered on August 27, 2020).
背景
在大多数既往研究中，单孔腹腔镜手术（SILS）治疗结直肠癌（CRC）在短期内是安全可行的。然而，长期肿瘤学结果尚不确定，因为仅有少数研究包含了长期生存数据。SILS 治疗 CRC 仍处于研究的早期阶段。需要进一步的研究，特别是大规模的前瞻性随机对照试验，以评估 SILS 治疗 CRC 的价值。
方法
本研究是一项前瞻性、多中心、开放标签、非劣效性、平行组随机对照临床试验，旨在比较 SILS 与传统腹腔镜手术（CLS）治疗 CRC 的长期肿瘤学结果。符合条件的 710 例患者将按照 1:1 的比例使用中央、动态、分层区组随机化方法分为 SILS 组或 CLS 组。年龄在 18 至 85 岁之间，性别不限，诊断为腹膜反射以上的 cT1-4aN0-2M0 期 CRC，肿瘤大小不超过 5cm 的患者将被纳入研究。主要终点是 3 年无病生存率（DFS）。次要终点包括：术中结果、术后恢复、术后疼痛评估、病理结果、早期发病率和死亡率、美容效果、生活质量、3 年总生存率（OS）、切口疝发生率、5 年 DFS 和 5 年 OS。前两次随访将安排在术后 1 个月和 3 个月，然后在前两年每 3 个月随访一次，接下来的 3 年每 6 个月随访一次。
讨论
目前，尚无设计用于研究 SILS 治疗 CRC 的长期肿瘤学结果的随机对照试验（RCT）。本研究有望为 SILS 与 CLS 治疗 CRC 的肿瘤学结果提供临床证据，以促进其广泛应用。
试验注册
ClinicalTrials.gov：NCT04527861（注册于 2020 年 8 月 27 日）。
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