Comparison of Clinical Outcomes According to Timing of Dietary Restart After Colorectal Endoscopic Submucosal Dissection: A Prospective, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 5
- 主要终点
- early post-procedural adverse events occurring within 24 hours after the procedure
研究概览
简要总结
Currently, there are no clear guidelines regarding the optimal timing for dietary restart after gastrointestinal endoscopic submucosal dissection (ESD). While several studies have addressed upper gastrointestinal ESD, a meta-analysis reported that early feeding, initiated within one day after the procedure, showed no statistically significant difference in complication rates compared to delayed feeding initiated after two or more days. Moreover, early feeding was associated with shorter hospital stays and higher patient satisfaction. However, to the best of our knowledge, no studies have investigated early feeding in colorectal ESD.
On the other hand, in the context of surgical procedures involving the gastrointestinal tract, several studies suggest that early feeding may offer clinical advantages over delayed feeding.
The aim of this study is to explore the optimal timing for dietary restart following colorectal ESD. In the early feeding group (<24 hours), patients begin water intake if no abnormalities are observed during a follow-up examination conducted two hours post-procedure. If no further issues arise after an additional two hours, a liquid diet is initiated. In contrast, the delayed feeding group (>24 hours) maintains fasting on the day of the procedure and begins a liquid diet the following day. The study will compare the early and delayed feeding groups in terms of early post-procedural adverse events (occurring within 24 hours after the procedure)(e.g., bleeding, perforation, post-coagulation syndrome), patient satisfaction, and delayed post-procedural adverse events (occurring more than 24 hours after the procedure).
详细描述
● Sample Size Calculation: This study was designed as a non-inferiority trial. The expected incidence of post-procedural adverse events was assumed to be 1.5% in both groups. Sample size estimation was performed using PASS version 11, assuming a non-inferiority margin of 5%, a one-sided alpha level of 0.025, and 80% power. Based on these assumptions, 96 patients were required per group. After allowing for a 5% dropout rate, the final target enrollment was set at 102 patients per group, resulting in a total sample size of 204 patients.
● Randomization and Blinding: This clinical study employs block randomization to allocate participants to the experimental group (early diet resumption, EDR) and the control group (delayed diet resumption, DDR) in a 1:1 ratio. Blinding will not be applied. A randomization table will be generated independently by a statistician from the Medical Statistics Department of Pusan National University Hospital, using the blockrand package in R (version 4.3.3; R Core Team, 2024, http://cran.r-project.org). The block size will remain blinded.
● Research Participation Procedure: After signing the consent form, the admission process is initiated. Basic tests such as blood tests, ECG, and chest/abdominal X-rays are conducted. Fasting and bowel preparation are performed the day before the procedure.
● Procedure and Initial Management: On the day of the procedure, both groups undergo standard colorectal ESD. Two hours after the procedure, a physical examination, CBC, and chest/abdominal X-rays are performed.
● Dietary Group Classification: Early Feeding Group: If no abnormalities are found during the examination 2 hours after the procedure, water intake begins, followed by a liquid diet and then a porridge diet if no complications occur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients were adults (≥19 years) scheduled to undergo colorectal ESD who met one or more of the following indications:
- •Differentiated early colorectal cancer ≤5 cm without ulceration and confined to the mucosa
- •Laterally spreading tumor ≥2 cm
- •Sessile polyp ≥2 cm
- •Adenoma with fibrosis
- •Differentiated early colorectal cancer without lymph node metastasis
- •Colorectal subepithelial lesion These indications correspond to the reimbursement criteria for colorectal ESD under the Korean National Health Insurance system.
排除标准
- •were as follows:
- •Untreated colorectal cancer
- •Active inflammatory bowel disease
- •Coagulopathy or prothrombin time-international normalized ratio >1.5 despite medical correction, pregnancy
- •Endoscopically unmanageable perforation or bleeding during the procedure
- •Refusal to provide informed consent
研究组 & 干预措施
Late feeding group
The group implementing late feeding (> 24hr).
干预措施: Late feeding (Other)
Early feeding group
The group implementing early feeding (< 24hr).
干预措施: Early feeding (Other)
结局指标
主要结局
early post-procedural adverse events occurring within 24 hours after the procedure
时间窗: Through study completion, an average of 1 year
Bleeding, perforation, Post procedural coagulation syndrome
次要结局
- patient satisfaction(through study completion, an average of 1 year)
- delayed post-procedural adverse events occurring more than 24 hours after the procedure(Through study completion, an average of 1 year)
研究者
Seung Min Hong
Professor
Pusan National University Hospital