External Application of Traditional Chinese Medicine Mirabilite for the Prevention of Incisional Complications and Promotion of Gastrointestinal Function Recovery in Gastrointestinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 301
- 试验地点
- 1
- 主要终点
- Incidence of Complications (%)
研究概览
简要总结
This study evaluates the efficacy and safety of topical Mirabilite (sodium sulfate) application for managing postoperative outcomes in patients undergoing gastrointestinal cancer surgery. Conducted at the First Affiliated Hospital of Nanchang University, this randomized controlled trial assesses Mirabilite's potential to mitigate postoperative complications, including surgical site infections and abdominal distention, and to expedite the recovery of gastrointestinal function. Participants are randomly assigned to either a Mirabilite treatment group or a standard care control group. Follow-up assessments, extending up to five years, will examine incision healing, complication incidence, and metrics of gastrointestinal recovery to provide robust evidence on the clinical benefits of Mirabilite in surgical settings.
详细描述
This single-center randomized controlled trial investigates the efficacy of Mirabilite in enhancing postoperative outcomes for patients undergoing gastrointestinal surgery, with a specific focus on individuals receiving abdominal incisions for gastrointestinal malignancies. Abdominal surgeries often lead to complications such as incision fat liquefaction, surgical site infections (SSI), and postoperative gastrointestinal dysfunction, issues for which traditional treatment methods have shown limited success. This study aims to assess Mirabilite's potential therapeutic advantages in this context.
Mirabilite, a mineral widely used in traditional Chinese medicine, possesses properties that facilitate swelling reduction, pain relief, and tissue repair, attributed to its high osmotic pressure. Approximately 300 participants are randomly allocated to either a Mirabilite intervention group or a standard postoperative care group. In the intervention group, Mirabilite is applied topically to surgical incisions, with subsequent evaluations focusing on incision healing, gastrointestinal function recovery, and markers of inflammation.
Primary endpoints include incision healing duration, time to first flatus, SSI incidence, postoperative pain scores, and hospital length of stay. This trial seeks to substantiate the role of Mirabilite as a cost-effective and safe adjunct therapy for postoperative recovery in gastrointestinal surgery, with the potential to reduce hospital stays and mitigate complication rates.
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
- •Underwent gastrointestinal surgery. Aged between 18 and 80 years. Provided signed informed consent.
排除标准
- •Required unplanned surgical intervention within 30 days postoperatively. Presented with emergency conditions, such as bowel obstruction or gastrointestinal bleeding, or diagnosed with severe psychiatric disorders.
- •Underwent surgical procedures for advanced malignancies, including palliative or bypass surgeries.
- •Classified as American Society of Anesthesiologists (ASA) Physical Status >
- •Requested withdrawal from the study after enrollment. Demonstrated non-compliance or utilized mirabilite for fewer than three consecutive days.
- •Experienced unexpected discharge during the study period.
研究组 & 干预措施
Mirabilite Application Group
Participants will receive a 500-gram external application of Mirabilite on the abdominal incision site, replaced regularly to maintain efficacy.
干预措施: Topical Mirabilite Application for Postoperative Gastrointestinal Patients (Procedure)
Standard Care Group
Participants will receive standard postoperative care with regular sterile dressing changes, without additional topical treatments.
干预措施: Standard Postoperative Care for Gastrointestinal Patients (Procedure)
结局指标
主要结局
Incidence of Complications (%)
时间窗: Within 30 days post-surgery
The overall incidence of postoperative complications, including any adverse events directly related to the surgery.
Incidence of Surgical Site Infection (SSI) (%)
时间窗: Within 30 days post-surgery
The incidence rate of surgical site infections, categorized as superficial or deep infections at the incision site.
Time to First Flatus (Days)
时间窗: 1 day after operation
The duration in days from surgery to the first passage of flatus, indicating the resumption of gastrointestinal motility.
次要结局
- Incision Length (cm)(Measured on the day of surgery.)
- Operative Time (Minutes)(Recorded on the day of surgery.)
- C-Reactive Protein (CRP) Levels (mg/L)(Measured on postoperative days 1, 4, and 7.)
- Visual Analog Scale (VAS) Pain Scores(Recorded on postoperative days 1, 2, and 3.)
- Daily Drainage Volume (mL)(Measured daily from postoperative days 1 through 7.)
- Postoperative Serum Protein Levels (g/L)(Measured on postoperative days 1 and 4.)
- Length of Postoperative Hospital Stay (Days)(1 day after operation)
- Surgical Type(Recorded on the day of surgery.)
- Intraoperative Blood Loss (mL)(Measured on the day of surgery.)
研究者
Taiyuan Li
professor
Nanchang University