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

NCT06674200 | Completed

• 1 other identifier: COMPARISON study
• Study Type: interventional
• Target: 11,243
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colorectal Cancer (CRC)

Keywords

Parastomal Hernia; Mesenteric Molding Suturing; Colostomy Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of PSH within one year postoperatively

  Incidence of PSH within one year postoperatively

  1 year

Secondary Outcomes (2)

• Incidence of stoma-related complications

  1 year

• Operative time and time to stoma function recovery

  1 year

Study Arms (2)

Regular

ACTIVE COMPARATOR

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

Mesenteric Molding Suturing Group

EXPERIMENTAL

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

Interventions

Mesenteric Molding Suturing Group PROCEDURE

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.

Regular

Regular PROCEDURE

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.

Mesenteric Molding Suturing Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 5, 2024
• Study Start: January 1, 2002
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share