Clinical trial NCT06696729: External Application of Mirabilite to Promote Recovery in Patients After Gastrointestinal Surgery
Official title: External Application of Traditional Chinese Medicine Mirabilite for the Prevention of Incisional Complications and Promotion of Gastrointestinal Function Recovery in Gastrointestinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Surgery
Mirabilite
Surgical Site Infection
Postoperative Gastrointestinal Dysfunction
Lead sponsor: Nanchang University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 \> 3. 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.

Primary outcomes:
measure: Incidence of Complications (%)
timeFrame: Within 30 days post-surgery
measure: Incidence of Surgical Site Infection (SSI) (%)
timeFrame: Within 30 days post-surgery
measure: Time to First Flatus (Days)
timeFrame: 1 day after operation
Secondary outcomes:
measure: C-Reactive Protein (CRP) Levels (mg/L)
timeFrame: Measured on postoperative days 1, 4, and 7.
measure: Visual Analog Scale (VAS) Pain Scores
timeFrame: Recorded on postoperative days 1, 2, and 3.
measure: Daily Drainage Volume (mL)
timeFrame: Measured daily from postoperative days 1 through 7.
measure: Postoperative Serum Protein Levels (g/L)
timeFrame: Measured on postoperative days 1 and 4.
measure: Length of Postoperative Hospital Stay (Days)
timeFrame: 1 day after operation
measure: Operative Time (Minutes)
timeFrame: Recorded on the day of surgery.
measure: Incision Length (cm)
timeFrame: Measured on the day of surgery.
measure: Surgical Type
timeFrame: Recorded on the day of surgery.
measure: Intraoperative Blood Loss (mL)
timeFrame: Measured on the day of surgery.
Other outcomes:
Locations:
city: NanChang
country: China
facility: the First Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
affiliation: Department of General Surgery, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang 330006, Jiangxi Province, China
name: Ye ShanPing Dr. Ye
role: STUDY_CHAIR
References: