Clinical trial · Interventional
A Retrospective Study Comparing the Incidence of Parastomal Hernia After Mesenteric Molding Suturing and Non-molding Suturing in Colostomy Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
\### Brief Summary * Title\*\*: A Retrospective Study Comparing the Incidence of Parastomal Hernia After Mesenteric Molding Suturing and Non-molding Suturing in Colostomy Surgery * Background\*\*: 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\*\*: * \*\*Primary Objective\*\*: To compare the incidence of PSH within one year postoperatively between the mesenteric molding suturing group and the non-molding suturing group. * \*\*Secondary Objectives\*\*: To evaluate the impact of the two suturing methods on stoma-related complications (such as stoma bleeding, stoma necrosis, and stoma prolapse), operative time, and time to stoma function recovery. * Methods\*\*: * \*\*Design\*\*: Retrospective cohort study. * \*\*Participants\*\*: Patients who underwent colostomy surgery. * \*\*Interventions\*\*: Mesenteric molding suturing vs. non-molding suturing. * \*\*Data Collection\*\*: Baseline data (age, gender, BMI, medical history) and follow-up data (incidence of PSH, stoma-related complications, operative time, and time to stoma function recovery) were collected from medical records. * \*\*Statistical Analysis\*\*: The primary outcome (incidence of PSH) will be analyzed using the Chi-square test or Fisher's exact test. Secondary outcomes will be analyzed using appropriate statistical methods (e.g., t-test, Mann-Whitney U test, ANOVA). * Expected Outcomes\*\*: \- The study aims to provide evidence on the effectiveness of mesenteric molding suturing in reducing the incidence of PSH and improving postoperative outcomes in colostomy patients. * Ethical Considerations\*\*: * The study will adhere to the principles of the Declaration of Helsinki. * All data will be anonymized to protect patient confidentiality. * The study protocol will be approved by the local ethics committee. 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mesenteric Molding Suturing Group | Procedure | — | UNRESOLVED |
| Regular | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Regular
- description
- 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.
- interventionNames
- Procedure: Mesenteric Molding Suturing Group
- type
- EXPERIMENTAL
- label
- Mesenteric Molding Suturing Group
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 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.
References
Publications (1)
- DERIVEDTang J, Wang L, Ji D, Du J, Jin K, Wang Y, Wang X, Sun Y. Association of Mesenteric Molding Suturing on Parastomal Hernia Incidence: Retrospective Study. J Surg Res. 2025 Nov;315:973-981. doi: 10.1016/j.jss.2025.10.017. Epub 2025 Nov 10. PMID 41218377