An interventional study of Mesenteric Molding Suturing Group and Regular in Colorectal Cancer (CRC), sponsored by The First Affiliated Hospital with Nanjing Medical University. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-05.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment
### Brief Summary
Colostomy surgery is a common procedure for treating various gastrointestinal diseases, but it is associated with a high incidence of parastomal hernia (PSH), which can significantly affect patients' quality of life and increase healthcare costs. This study aims to compare the incidence of PSH within one year after colostomy surgery between patients who underwent mesenteric molding suturing and those who underwent non-molding suturing.
Objectives**:
Methods**:
Expected Outcomes**:
Ethical Considerations**:
This retrospective study will contribute valuable insights into the optimal surgical techniques for reducing the incidence of PSH in colostomy patients, ultimately improving their quality of life and reducing healthcare costs.
Detailed Description
Objectives
Methods
Interventions
During the stoma surgery, the mesentery is shaped and sutured to enhance the support around the stoma and reduce the risk of hernia formation. The specific steps include:
The stoma surgery is performed using conventional non-molding suturing techniques. The specific steps include:
Data Collection - **Baseline Data**:
Statistical Analysis - **Primary Outcome Measure**: Incidence of PSH within one year postoperatively.
Ethical Considerations - The study will adhere to the principles of the Declaration of Helsinki.
Expected Outcomes - This study aims to provide scientific evidence for best practices in colostomy surgery, particularly in reducing PSH and other complications.
Study Limitations
By conducting this detailed retrospective study, we aim to provide robust evidence to guide clinical practice and improve the outcomes for patients undergoing colostomy surgery.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 11,243 is above the median of 80 across 739 interventional studies indexed under Hernia.
Browse Hernia studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
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Age 18 years or older. Patients requiring colostomy surgery. Ability to provide written informed consent. Expected survival of more than one year. No severe comorbidities such as heart, lung, liver, or kidney dysfunction.
Exclusion Criteria:
Pregnant or breastfeeding women. History of major abdominal surgery that could affect the development of PSH. Mental illness that impairs understanding of the study content and ability to give informed consent.
Patients receiving immunosuppressive therapy or chemotherapy.
The stoma surgery is performed using conventional non-molding suturing techniques. The specific steps include: Select an appropriate stoma site, typically within the rectus abdominis muscle. Perform routine suturing around the stoma without additional mesentery shaping. Form the stoma, ensuring a tight fit of the surrounding tissues.
Procedure: Mesenteric Molding Suturing Group
During the stoma surgery, the mesentery is shaped and sutured to enhance the support around the stoma and reduce the risk of hernia formation. The specific steps include: Select an appropriate stoma site, typically within the rectus abdominis muscle. Separate the mesentery around the stoma and shape it into a sturdy support structure. Use non-absorbable sutures to fix the shaped mesentery to the abdominal wall, forming a sturdy support structure. Form the stoma on the support structure, ensuring a tight fit of the surrounding tissues.
Procedure: Regular
During the stoma surgery, the mesentery is shaped and sutured to enhance the support around the stoma and reduce the risk of hernia formation. The specific steps include: Select an appropriate stoma site, typically within the rectus abdominis muscle. Separate the mesentery around the stoma and shape it into a sturdy support structure. Use non-absorbable sutures to fix the shaped mesentery to the abdominal wall, forming a sturdy support structure. Form the stoma on the support structure, ensuring a tight fit of the surrounding tissues.
The stoma surgery is performed using conventional non-molding suturing techniques. The specific steps include: Select an appropriate stoma site, typically within the rectus abdominis muscle. Perform routine suturing around the stoma without additional mesentery shaping. Form the stoma, ensuring a tight fit of the surrounding tissues.
Incidence of PSH within one year postoperatively
Incidence of PSH within one year postoperatively
Time frame: 1 year
Incidence of stoma-related complications
stoma bleeding, stoma necrosis, and stoma prolapse: use the Chi-square test or Fisher's exact test.
Time frame: 1 year
Operative time and time to stoma function recovery
Operative time and time to stoma function recovery
Time frame: 1 year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University