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

NCT05061589 | Unknown

• 1 other identifier: BFH-IRFPH
• Study Type: observational
• Target: 712
• Locations: 1 country
• Sites: 2

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.

Conditions

Hernia; Stoma Colostomy

Outcome Measures

Primary Outcomes (1)

• Incidence of parastomal hernia

  1 year after permanent colostomy

Secondary Outcomes (4)

• Incidence of parastomal hernia

  2 year after permanent colostomy

• Incidence of parastomal hernia

  5 year after permanent colostomy

• risk factors of parastomal hernia

  1 year after permanent colostomy

• classification of parastomal hernia

  1 year after permanent colostomy

Interventions

permanent colostomy PROCEDURE

An operation that creates an opening for the colon through the abdomen

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients underwent permanent colostomy after colorectal surgery

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (2)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

Beijing Friendship Hospital, Capital medical University

Beijing, Xicheng Dis, 100050, China

Location

Related Publications (6)

• Antoniou SA, Agresta F, Garcia Alamino JM, Berger D, Berrevoet F, Brandsma HT, Bury K, Conze J, Cuccurullo D, Dietz UA, Fortelny RH, Frei-Lanter C, Hansson B, Helgstrand F, Hotouras A, Janes A, Kroese LF, Lambrecht JR, Kyle-Leinhase I, Lopez-Cano M, Maggiori L, Mandala V, Miserez M, Montgomery A, Morales-Conde S, Prudhomme M, Rautio T, Smart N, Smietanski M, Szczepkowski M, Stabilini C, Muysoms FE. European Hernia Society guidelines on prevention and treatment of parastomal hernias. Hernia. 2018 Feb;22(1):183-198. doi: 10.1007/s10029-017-1697-5. Epub 2017 Nov 13.

  PMID: 29134456 BACKGROUND

• Hong SY, Oh SY, Lee JH, Kim DY, Suh KW. Risk factors for parastomal hernia: based on radiological definition. J Korean Surg Soc. 2013 Jan;84(1):43-7. doi: 10.4174/jkss.2013.84.1.43. Epub 2012 Dec 26.

  PMID: 23323235 BACKGROUND

• Lian L, Wu XR, He XS, Zou YF, Wu XJ, Lan P, Wang JP. Extraperitoneal vs. intraperitoneal route for permanent colostomy: a meta-analysis of 1,071 patients. Int J Colorectal Dis. 2012 Jan;27(1):59-64. doi: 10.1007/s00384-011-1293-6. Epub 2011 Sep 3.

  PMID: 21892608 BACKGROUND

• Pilgrim CH, McIntyre R, Bailey M. Prospective audit of parastomal hernia: prevalence and associated comorbidities. Dis Colon Rectum. 2010 Jan;53(1):71-6. doi: 10.1007/DCR.0b013e3181bdee8c.

  PMID: 20010354 BACKGROUND

• Hardt J, Meerpohl JJ, Metzendorf MI, Kienle P, Post S, Herrle F. Lateral pararectal versus transrectal stoma placement for prevention of parastomal herniation. Cochrane Database Syst Rev. 2019 Apr 24;4(4):CD009487. doi: 10.1002/14651858.CD009487.pub3.

  PMID: 31016723 BACKGROUND

• Jones HG, Rees M, Aboumarzouk OM, Brown J, Cragg J, Billings P, Carter B, Chandran P. Prosthetic mesh placement for the prevention of parastomal herniation. Cochrane Database Syst Rev. 2018 Jul 20;7(7):CD008905. doi: 10.1002/14651858.CD008905.pub3.

  PMID: 30027652 BACKGROUND

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhongtao Zhang

  Department of General Surgery, Beijing Friendship Hospital, Capital Medical University

  STUDY CHAIR

Central Study Contacts

Hongwei Yao, MD,PhD

CONTACT

+8613611015609; yaohongwei@ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 29, 2021
• Study Start: October 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)