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

September 20, 2021 updated by: Zhongtao Zhang, Beijing Friendship Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

712

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Beijing Friendship Hospital
    • Xicheng Dis
      • Beijing, Xicheng Dis, China, 100050
        • Beijing Friendship Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients underwent permanent colostomy after colorectal surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of parastomal hernia
Time Frame: 1 year after permanent colostomy
1 year after permanent colostomy

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of parastomal hernia
Time Frame: 2 year after permanent colostomy
2 year after permanent colostomy
Incidence of parastomal hernia
Time Frame: 5 year after permanent colostomy
5 year after permanent colostomy
risk factors of parastomal hernia
Time Frame: 1 year after permanent colostomy
1 year after permanent colostomy
classification of parastomal hernia
Time Frame: 1 year after permanent colostomy
1 year after permanent colostomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Investigators

  • Study Chair: Zhongtao Zhang, Department of General Surgery, Beijing Friendship Hospital, Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

September 20, 2021

First Submitted That Met QC Criteria

September 20, 2021

First Posted (Actual)

September 29, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BFH-IRFPH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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