CompletedNot Applicable

A Retrospective Study Comparing the Incidence of Parastomal Hernia After Mesenteric Molding Suturing and Non-molding Suturing in Colostomy Surgery

11,243 participantsStarted 2002-01-01

Plain-language summary

\### 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of PSH within one year postoperatively

Timeframe: 1 year

Trial details

NCT IDNCT06674200

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-01

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