Incidence and Risk Factors of Parastomal Hernia in Patients With Permanent Colostomy in China

• Conditions: Stoma Colostomy; Hernia

• Registration Number: NCT05061589
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

Parastomal hernia refers to the protrusion of the area around the stoma or the ectopic protrusion of abdominal contents from the stoma (colostomy, ileostomy, ileostomy for bladder) in the abdominal wall defect. Parastomal hernia is one of the common complications after permanent colostomy. According to guidelines published by the European Hernia Society, the overall incidence of parastomal hernia is unknown, but it can be predicted to be over 30% at 12 months, over 40% at 2 years, and over 50% at longer follow-up periods. Parastomal hernia may have no obvious symptoms at the beginning or only protrusion around the stoma. However, with the progression of the disease, the protrusion site may gradually increase, resulting in leakage, skin ulcers, perforation, incarceration, obstruction, strangulation and other serious complications. It will seriously affect the quality of life of patients and increase the medical burden and cost.

Risk factors related to parastomal hernia are currently considered to be mainly related to the patient's own factors and surgical factors. Studies have shown that female, old age, obesity, cardiopulmonary diseases, diabetes, long-term use of cortisol and other factors can increase the incidence of parastomal hernia in patients . Methods of stoma including extraperitoneal stoma, appropriate aperture of stoma and preventive mesh placement can reduce the incidence of parastomal hernia in patients.

In this study, patients with permanent colostomy and relevant information of surgery as well as the current incidence of parastomal hernia will be retrospectively collected in some high-level and high-volume tertiary hospitals in China. This study will be helpful to provide data reference for subsequent studies in this field.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-09-20
• Last Update Submitted: 2021-09-20
• Study First Posted: 2021-09-29
• Last Update Posted: 2021-09-29
• Study Start: 2021-10-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 712

Inclusion Criteria

• permanent colostomy after colorectal surgery for benign or malignant diseases
• No previous colostomy history

Exclusion Criteria

• No CT scan follow-up at 1 year after surgery
• Another ileocolonic diversion was performed except for the cause of parastomal hernia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of parastomal hernia	1 year after permanent colostomy

Secondary Outcome Measures

Name	Time	Method
risk factors of parastomal hernia	1 year after permanent colostomy
Incidence of parastomal hernia	5 year after permanent colostomy
classification of parastomal hernia	1 year after permanent colostomy

Trial Locations

Locations (2)

Beijing Friendship Hospital, Capital medical University; 🇨🇳 Beijing, Xicheng Dis, China

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China