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HerniaNCT05061589

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

An observational study of Hernia and Stoma Colostomy, run by Beijing Friendship Hospital at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Hernia, Stoma Colostomy
What is being tested?
permanent colostomy
Type of treatment
Surgery or procedure
How many people
712 participants
Where
2 sitesChina
Study dates
1 Oct 2021to 1 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients underwent permanent colostomy after colorectal surgery

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Hongwei Yao, MD,PhD contact

+8613611015609 ext. 63139203

yaohongwei@ccmu.edu.cn

China2 sites

  • Beijing Friendship Hospital

    Beijing, Beijing Municipality, 100050

  • Beijing Friendship Hospital, Capital medical University

    Beijing, Xicheng Dis, 100050

Other trials in China

About this study

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.

Being tested
permanent colostomy
Medical subject headings
Hernia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • permanent colostomyProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of parastomal hernia

    Measured: 1 year after permanent colostomy

Secondary outcomes (4)

  1. Incidence of parastomal hernia

    Measured: 2 year after permanent colostomy

  2. Incidence of parastomal hernia

    Measured: 5 year after permanent colostomy

  3. risk factors of parastomal hernia

    Measured: 1 year after permanent colostomy

  4. classification of parastomal hernia

    Measured: 1 year after permanent colostomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2021
  2. Study start1 Oct 2021 (estimated)
  3. Primary completion1 May 2022 (estimated)
  4. Study completion1 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
712 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05061589
Sponsor's protocol ID
BFH-IRFPH
Status last verified
Sep 2021
First submitted
20 Sep 2021
Last updated
29 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29134456

  • 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.

    PubMed 23323235

  • 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.

    PubMed 21892608

  • 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.

    PubMed 20010354

  • 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.

    PubMed 31016723

  • 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.

    PubMed 30027652

Questions about this trial

What is this clinical trial studying?

An observational study of Hernia and Stoma Colostomy, run by Beijing Friendship Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hongwei Yao, MD,PhD (+8613611015609 ext. 63139203, yaohongwei@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of parastomal hernia (time frame: 1 year after permanent colostomy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05061589, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.

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