External Application of Traditional Chinese Medicine Mirabilite for the Prevention of Incisional Complications and Promotion of Gastrointestinal Function Recovery in Gastrointestinal Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 301
- Locations
- 1
- Primary Endpoint
- Incidence of Complications (%)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Underwent gastrointestinal surgery. Aged between 18 and 80 years. Provided signed informed consent.
Exclusion Criteria
- •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.
Arms & Interventions
Mirabilite Application Group
Participants will receive a 500-gram external application of Mirabilite on the abdominal incision site, replaced regularly to maintain efficacy.
Intervention: 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.
Intervention: Standard Postoperative Care for Gastrointestinal Patients (Procedure)
Outcomes
Primary Outcomes
Incidence of Complications (%)
Time Frame: 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) (%)
Time Frame: 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)
Time Frame: 1 day after operation
The duration in days from surgery to the first passage of flatus, indicating the resumption of gastrointestinal motility.
Secondary Outcomes
- 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.)
Investigators
Taiyuan Li
professor
Nanchang University