RISE Ileocecal Valve Functional Reconstruction for the Prevention of Postoperative Intestinal Dysfunction After Robotic/Laparoscopic Right Hemicolectomy: a Single-blind, Two-arm, Multicenter Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 188
- 主要终点
- Time to first formed stool after surgery (Bristol stool score < 4).
研究概览
简要总结
The traditional surgical treatment for right-sided colon cancer involves the removal of an important structure, the ileocecal valve, which includes the ileocecal valve. This can lead to problems such as diarrhea and malnutrition in patients. This study reconstructs an artificial ileocecal valve through intraoperative suturing to compensate for the function of the original ileocecal valve. The control group will undergo the routine resection of the right-sided colon, including the ileocecal valve. This is a randomized controlled study. Patients enrolled will be randomly assigned to the experimental group (ileocecal valve reconstruction during surgery) or the control group (no ileocecal valve reconstruction), with no differences in other treatment procedures. After a series of follow-up observations, the research team will analyze the safety and effectiveness of the method of ileocecal valve reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18-80 years;
- •ASA score ≤ 3;
- •Patients newly diagnosed with tumors located in the appendix, ileocecal region, ascending colon, hepatic flexure of the colon, or the right one-third of the transverse colon, or those scheduled to undergo laparoscopic radical right hemicolectomy;
- •No history of other gastrointestinal diseases (except for intestinal polyps or gallstones);
- •Willing to participate in the study and sign the informed consent form;
- •Complete clinical data available.
排除标准
- •Presence of other malignant tumors in different organs;
- •Tumor invasion into adjacent organs;
- •Patients with concurrent infectious diseases or autoimmune diseases (e.g., Crohn's disease);
- •Patients with congenital or acquired metabolic disorders;
- •Use of antibiotics or other microbiota-altering medications within one month prior to enrollment;
- •Changes in surgical plan resulting in the resection not including the ileocecal valve.
研究组 & 干预措施
RISE anastomosis
After performing a conventional right hemicolectomy, an additional step is carried out in which sutures are used to artificially reconstruct an ileocecal valve structure at the ileal stump before proceeding with the ileocolic anastomosis.
干预措施: RISE (Revolute Insert Side-End ileocecal valve reconstruction) (Procedure)
Control
Conventional right hemicolectomy was performed, with the ileocecal valve included in the resection.
结局指标
主要结局
Time to first formed stool after surgery (Bristol stool score < 4).
时间窗: 1 week after surgery
According to the Bristol stool scale, stools are categorized into seven types. Since stool form is related to the duration of colonic transit, the scale can be used to assess intestinal transit time and evaluate anastomotic function. A score \>5 is defined as diarrhea, with a score of 6 indicating mild diarrhea and a score of 7 indicating severe diarrhea.
次要结局
- EORTCQLQ-CR2930(baseline, 1 month after surgery.)
- gut microbiota(1 month, 3 months, 6 months and 1 year after surgery.)
- Operation time(during the surgery)
- anastomosis time(during surgery)
- intraoperative blood loss(during surgery)
- Complications within 30 days after surgery(30 days after surgery)
- anastomosis healing(3 months, 6 months and 1 year after surgery)
- albumin level(3 days, 1 month, 3 months, 6 months and 1 year after surgery.)
- bile acid(3 days, 1 month, 3 months, 6 months and 1 year after surgery)
- VitB12(3 days, 1 month, 3 months, 6 months and 1 year after surgery)
- total protein(3 days, 1 month, 3 months, 6 months and 1 year after surgery)
- EORTCQLQ-C30(baseline, 1 month after surgery.)
研究者
Weidong Xiao
Chief of General Surgery
Army Medical University, China