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NCT06674200Completed

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

Source: ClinicalTrials.gov · Last updated 5 Nov 2024

Brief summary (registry, in English)

\### 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.

Status (registry)
Completed
Study type
Interventional
Enrollment
11243 (actual)
First submitted
30 Oct 2024
Start date
1 Jan 2002
Primary completion date
1 Oct 2024
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
NCT number
NCT06674200

What you commit to

  • Study type: Interventional
  • Participants enrolled: 11243
  • From 1 Jan 2002 to the primary completion date, 1 Oct 2024
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients receiving immunosuppressive therapy or chemotherapy.

Other illness

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.