Gastrointestinal SurgeryNCT06696729
External Application of Mirabilite to Promote Recovery in Patients After Gastrointestinal Surgery
A study testing Topical Mirabilite Application for Postoperative Gastrointestinal Patients and Standard Postoperative Care for Gastrointestinal Patients in people with Gastrointestinal Surgery and Mirabilite, run by Nanchang University at 1 site in China.
Trial summary
This study evaluates the efficacy and safety of topical Mirabilite (sodium sulfate) application for managing postoperative outcomes in patients undergoing gastrointestinal cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Surgery, Mirabilite, Surgical Site Infection
- What is being tested?
- Topical Mirabilite Application for Postoperative Gastrointestinal Patients and Standard Postoperative Care for Gastrointestinal Patients
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 301 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Underwent gastrointestinal surgery. Aged between 18 and 80 years. Provided signed informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
About this study
Official title: External Application of Traditional Chinese Medicine Mirabilite for the Prevention of Incisional Complications and Promotion of Gastrointestinal Function Recovery in Gastrointestinal Surgery
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.
Read the 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.
- Conditions
- Gastrointestinal Surgery, Mirabilite, Surgical Site Infection, Postoperative Gastrointestinal Dysfunction
- Being tested
- Topical Mirabilite Application for Postoperative Gastrointestinal Patients, Standard Postoperative Care for Gastrointestinal Patients
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Mirabilite Application for Postoperative Gastrointestinal PatientsProcedure or surgery
Participants in this group will receive an external application of 500 grams of Mirabilite (sodium sulfate decahydrate) beginning on postoperative day 1. The Mirabilite will be wrapped in a double layer of gauze and placed on top of the sterile dressing over the patient's abdominal incision, with the gauze bag secured by an abdominal binder. The application will be regularly replaced when it becomes damp and hardened to maintain continuous efficacy.
Standard Postoperative Care for Gastrointestinal PatientsProcedure or surgery
Participants in this group will receive standard postoperative care without the application of Mirabilite or any alternative topical treatment. Their surgical sites will be kept dry and clean, with regular sterile dressing changes as part of standard care protocols.
| Study group | Role | What they receive |
|---|---|---|
| Mirabilite Application Group | Experimental | Participants will receive a 500-gram external application of Mirabilite on the abdominal incision site, replaced regularly to maintain efficacy. Receives: Procedure: Topical Mirabilite Application for Postoperative Gastrointestinal Patients |
| Standard Care Group | Sham comparator | Participants will receive standard postoperative care with regular sterile dressing changes, without additional topical treatments. Receives: Procedure: Standard Postoperative Care for Gastrointestinal Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Complications (%)
The overall incidence of postoperative complications, including any adverse events directly related to the surgery.
Measured: Within 30 days post-surgery
Incidence of Surgical Site Infection (SSI) (%)
The incidence rate of surgical site infections, categorized as superficial or deep infections at the incision site.
Measured: Within 30 days post-surgery
Time to First Flatus (Days)
The duration in days from surgery to the first passage of flatus, indicating the resumption of gastrointestinal motility.
Measured: 1 day after operation
Secondary outcomes (9)
C-Reactive Protein (CRP) Levels (mg/L)
CRP levels as an inflammatory marker.
Measured: Measured on postoperative days 1, 4, and 7.
Visual Analog Scale (VAS) Pain Scores
Patient-reported pain levels on a 10-cm VAS scale (0 = no pain, 10 = worst pain).
Measured: Recorded on postoperative days 1, 2, and 3.
Daily Drainage Volume (mL)
Total daily output from drainage tubes, indicating postoperative exudation and inflammation.
Measured: Measured daily from postoperative days 1 through 7.
Postoperative Serum Protein Levels (g/L)
Serum protein levels, reflecting nutritional status and recovery.
Measured: Measured on postoperative days 1 and 4.
Length of Postoperative Hospital Stay (Days)
Total duration of hospital stay post-surgery.
Measured: 1 day after operation
Operative Time (Minutes)
Duration of the surgical procedure.
Measured: Recorded on the day of surgery.
Incision Length (cm)
Length of the surgical incision made during the procedure.
Measured: Measured on the day of surgery.
Surgical Type
Classification of the surgical procedure type
Measured: Recorded on the day of surgery.
Intraoperative Blood Loss (mL)
Total volume of blood lost during the procedure.
Measured: Measured on the day of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Oct 2023
- Primary completion30 Apr 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taiyuan Li, Nanchang University
- Investigators
- Ye ShanPing Dr. Ye, Study chair, Department of General Surgery, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang 330006, Jiangxi Province, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696729
- Sponsor's protocol ID
- IIT2024323
- Status last verified
- Nov 2024
- First submitted
- 13 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Application of Traditional Chinese Medicine Mirabilite for the Prevention of Incisional Complications and Promotion of Gastrointestinal Function Recovery in Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT06696729
- Acronym / sponsor ID
- IIT2024323
- Conditions
- Gastrointestinal Surgery, Mirabilite, Surgical Site Infection, Postoperative Gastrointestinal Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirabilite Application Group | Experimental | Procedure: Topical Mirabilite Application for Postoperative Gastrointestinal PatientsParticipants will receive a 500-gram external application of Mirabilite on the abdominal incision site, replaced regularly to maintain efficacy. |
| Standard Care Group | Sham comparator | Procedure: Standard Postoperative Care for Gastrointestinal PatientsParticipants will receive standard postoperative care with regular sterile dressing changes, without additional topical treatments. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Underwent gastrointestinal surgery. Aged between 18 and 80 years. Provided signed informed consent.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Mirabilite Application for Postoperative Gastrointestinal PatientsParticipants in this group will receive an external application of 500 grams of Mirabilite (sodium sulfate decahydrate) beginning on postoperative day 1. The Mirabilite will be wrapped in a double layer of gauze and placed on top of the sterile dressing over the patient's abdominal incision, with the gauze bag secured by an abdominal binder. The application will be regularly replaced when it becomes damp and hardened to maintain continuous efficacy. | Procedure or surgery | Mirabilite Application Group |
| Standard Postoperative Care for Gastrointestinal PatientsParticipants in this group will receive standard postoperative care without the application of Mirabilite or any alternative topical treatment. Their surgical sites will be kept dry and clean, with regular sterile dressing changes as part of standard care protocols. | Procedure or surgery | Standard Care Group |
Primary outcome
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.
9 secondary outcomes
C-Reactive Protein (CRP) Levels (mg/L)
Time frame: Measured on postoperative days 1, 4, and 7.
Visual Analog Scale (VAS) Pain Scores
Time frame: Recorded on postoperative days 1, 2, and 3.
Daily Drainage Volume (mL)
Time frame: Measured daily from postoperative days 1 through 7.
Postoperative Serum Protein Levels (g/L)
Time frame: Measured on postoperative days 1 and 4.
Length of Postoperative Hospital Stay (Days)
Time frame: 1 day after operation
Operative Time (Minutes)
Time frame: Recorded on the day of surgery.
Incision Length (cm)
Time frame: Measured on the day of surgery.
Surgical Type
Time frame: Recorded on the day of surgery.
Intraoperative Blood Loss (mL)
Time frame: Measured on the day of surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Gastrointestinal Surgery
Not yet recruiting
Tailored Nutrition vs. Exercise Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Not yet recruiting
Nurse-Led Prehabilitation Before Major Abdominal Cancer Surgery
Colorectal Cancer
RecruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ye ShanPing Dr. Ye study chair
Department of General Surgery, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang 330006, Jiangxi Province, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Mirabilite Application for Postoperative Gastrointestinal Patients and Standard Postoperative Care for Gastrointestinal Patients in people with Gastrointestinal Surgery and Mirabilite, run by Nanchang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Complications (%) (time frame: Within 30 days post-surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.