全腹腔镜全胃切除术（重叠式食管空肠吻合术）后早期经口进食的可行性与安全性研究方案：一项多中心随机对照试验
Study protocol for feasibility and safety of adopting early oral feeding in post total laparoscopic total gastrectomy (overlap esophagojejunostomy): A multicentre randomized controlled trial.
作者信息
Yang Jun, Yang Qinchuan, Wang Weidong, Chai Xiaoyan, Zhou Haikun, Yue Chao, Gao Ruiqi, Mo Zhenchang, Ji Panpan, Dong Danhong, Wei Jiangpeng, Liu Jinqiang, Zhang Ying, Li Xiaohua, Ji Gang
机构信息
Department of Gastrointestinal Surgery, Xijing Hospital, Air Force Military Medical University, Xi'an, China.
Department of Radiotherapy, Xijing Hospital, Air Force Military Medical University, Xi'an, China.
出版信息
Front Nutr. 2022 Aug 23;9:993896. doi: 10.3389/fnut.2022.993896. eCollection 2022.
BACKGROUND
Total laparoscopic total gastrectomy (TLTG) for gastric cancer, especially with overlap esophagojejunostomy, has been verified that it has advantages of minimally invasion, less intraoperative bleeding, and faster recovery. Meanwhile, early oral feeding (EOF) after the operation has been demonstrated to significantly promote early rehabilitation in patients, particularly with distal gastrectomy. However, due to the limited application of TLTG, there is few related research proving whether it is credible or safe to adopt EOF after TLTG (overlap esophagojejunostomy). So, it is urgent to start a prospective, multicenter, randomized clinical trials to supply high level evidence.
METHODS/DESIGN: This study is a prospective, multicenter, randomized controlled trial with 200 patients (100 in each group). These eligible participants are randomly allocated into two different groups, including EOF group and delay oral feeding (DOF) group after TLTG (overlap esophagojejunostomy). Anastomotic leakage will be carefully observed and recorded as the primary endpoints; the period of the first defecation and exhaust, postoperative length of stay and hospitalization expenses will be recorded as secondary endpoints to ascertain the feasibility and safety of adopting EOF after TLTG (overlap esophagojejunostomy).
DISCUSSION
Recently, the adoption of TLTG was limited due to its difficult anastomotic procedure, especially esophagojejunostomy. With the innovation and improvement of operating techniques, overlap esophagojejunostomy with linear staplers simplified the anastomotic steps and reduced operational difficulties after TLTG. Meanwhile, EOF had received increasing attention from surgical clinicians as a nutrition part of enhanced recovery after surgery (ERAS), which had shown better results in patients after distal gastrectomy. Considering the above factors, we implemented EOF protocol to evaluate the feasibility and safety of adopting EOF after TLTG (overlap esophagojejunostomy), which provided additional evidence for the development of clinical nutrition guidelines.
CLINICAL TRIAL REGISTRATION
[www.chictr.org.cn], identifier [ChiECRCT20200440 and ChiCTR2000040692].
背景
全腹腔镜全胃切除术（TLTG）治疗胃癌，尤其是采用重叠式食管空肠吻合术时，已证实具有微创、术中出血少、恢复快等优点。同时，术后早期经口进食（EOF）已被证明能显著促进患者早期康复，特别是在远端胃切除术患者中。然而，由于TLTG应用有限，很少有相关研究证明TLTG（重叠式食管空肠吻合术）后采用EOF是否可靠或安全。因此，迫切需要开展一项前瞻性、多中心、随机临床试验以提供高级别证据。
方法/设计：本研究是一项前瞻性、多中心、随机对照试验，纳入200例患者（每组100例）。这些符合条件的参与者被随机分为两组，包括TLTG（重叠式食管空肠吻合术）后的EOF组和延迟经口进食（DOF）组。将仔细观察并记录吻合口漏作为主要终点；首次排便和排气时间、术后住院时间和住院费用将作为次要终点，以确定TLTG（重叠式食管空肠吻合术）后采用EOF的可行性和安全性。
讨论
最近，由于其吻合操作困难，尤其是食管空肠吻合术，TLTG的应用受到限制。随着手术技术的创新和改进，使用直线切割吻合器的重叠式食管空肠吻合术简化了吻合步骤，降低了TLTG后的手术难度。同时，EOF作为术后加速康复（ERAS）营养部分，越来越受到外科临床医生的关注，在远端胃切除术后患者中已显示出更好的效果。考虑到上述因素，我们实施了EOF方案，以评估TLTG（重叠式食管空肠吻合术）后采用EOF的可行性和安全性，为临床营养指南的制定提供了额外证据。
临床试验注册
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