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

Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05061589
• Other study ID #: BFH-IRFPH
• Status: Not yet recruiting
• Start date: October 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: September 2021
• Source: Beijing Friendship Hospital
• Contact: Hongwei Yao, MD,PhD
• Phone: +8613611015609
• Email: yaohongwei[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 712
• Est. completion date: June 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Stoma Colostomy

Intervention

Procedure:
• permanent colostomy
An operation that creates an opening for the colon through the abdomen

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing
China	Beijing Friendship Hospital, Capital medical University	Beijing	Xicheng Dis

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

References & 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, Jänes A, Kroese LF, Lambrecht JR, Kyle-Leinhase I, López-Cano M, Maggiori L, Mandalà 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. Review. — View Citation

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:CD009487. doi: 10.1002/14651858.CD009487.pub3. — View Citation

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. — View Citation

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:CD008905. doi: 10.1002/14651858.CD008905.pub3. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of parastomal hernia		1 year after permanent colostomy
Secondary	Incidence of parastomal hernia		2 year after permanent colostomy
Secondary	Incidence of parastomal hernia		5 year after permanent colostomy
Secondary	risk factors of parastomal hernia		1 year after permanent colostomy
Secondary	classification of parastomal hernia		1 year after permanent colostomy