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

NCT ID: NCT05061589

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

712 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-06-01

Brief Summary

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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

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Conditions

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Hernia Stoma Colostomy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Interventions

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permanent colostomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhongtao Zhang

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhongtao Zhang

Role: STUDY_CHAIR

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

Locations

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Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Friendship Hospital, Capital medical University

Beijing, Xicheng Dis, China

Site Status

Countries

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China

Central Contacts

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Hongwei Yao, MD,PhD

Role: CONTACT

+8613611015609 ext. 63139203

References

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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.

Reference Type BACKGROUND
PMID: 29134456 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23323235 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21892608 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20010354 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31016723 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30027652 (View on PubMed)

Other Identifiers

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BFH-IRFPH

Identifier Type: -

Identifier Source: org_study_id

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