Living With a Parastomal Bulge - a Phenomenological-hermeneutic Study of Patients Lived Experiences

Hernia Clinical Trial

Official title:

Living With a Parastomal Bulge - a Phenomenological-hermeneutic Study of Patients Lived Experiences

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02889536
• Other study ID #: PreParE-qualitative
• Status: Completed
• Phase: N/A
• First received: August 30, 2016
• Last updated: October 20, 2016
• Start date: June 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research Ethics
• Study type: Observational

Clinical Trial Summary

A parastomal bulge (PB) is a frequent long-term complication after stoma formation. Most parastomal bulging occurs within two years of stoma formation but is seen up to 20 years post-surgery. A bulge may be relatively obvious or extremely difficult to diagnose, and descriptions of symptoms vary from 'asymptomatic', 'symptomatic' to 'high symptom load'. Previous studies report that quality of life as well as physical, psychological and social function are affected in patients with parastomal bulging. However, there is a lack of knowledge of patients' lived experiences with parastomal bulging. Insight into patients' experiences of symptoms in relation to parastomal bulging and the impact on everyday life may help identify issues of importance from the patient perspective. This, in turn, may help professionals to better understand and support patients with PB, and be of help when identifying patients' symptoms and determining relevant treatment strategies.

Description:

Stoma formation is a commonly performed procedure in colorectal surgery as part of treatment for malignant- and inflammatory bowel disease. A parastomal bulge (PB) is a frequent long-term complication with an incidence varying from 4% to more than 40% depending on ostomy type, follow-up and definitions.

A bulge may be relatively obvious or extremely difficult to diagnose. Most parastomal bulging occurs within two years of stoma formation but is seen up to 20 years post-surgery. Despite advances in primary surgical and repair techniques a rising incidence of parastomal bulging is expected in the future due to increased survival of cancer patients with an ostomy and limited dissemination of new techniques. Approximately one in three patients with a parastomal hernia requires a surgical hernia repair. However, the majority of patients are referred to non-surgical treatment by the enterostomal therapist in the outpatient clinic or do not seek professional help to manage the bulge. Previous studies report that quality of life as well as physical, psychological and social function are affected in patients with parastomal bulging.

Descriptions of symptoms vary from 'asymptomatic', 'symptomatic' to 'high symptom load'. Most frequently reported symptoms include ostomy leakage, skin problems, difficulty with ostomy appliance, limitation of activity, difficulty with clothing, cosmetic complaints, social restriction, erratic action of the stoma and a bearing down sensation at the site of the stoma. Rare, but serious complications include complete obstruction, strangulation or incarceration. However, there is a lack of knowledge of patients' lived experiences with parastomal bulging. Insight into patients' experiences of symptoms in relation to parastomal bulging and the impact on everyday life may help identify issues of importance from the patient perspective. This, in turn, may help professionals to better understand and support patients with PB, and be of help when identifying patients' symptoms and determining relevant treatment strategies.

Purpose: The aim is to study stoma patients experiences of parastomal bulging and symptoms in everyday life (in relation to an ileostomy and colostomy)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Permanent or temporary active sigmoidostomy, transversostomy, jejunostomy or ileostomy

PB diagnosed by stoma care nurse

Ability to speak and understand Danish

Exclusion Criteria:

Previous surgical repair for PB

Major incisional abdominal hernias

Study Design

N/A

Related Conditions & MeSH terms

• Hernia
• Ostomy
• Signs and Symptoms

Intervention

Other:
• Focus group interviews
Focus group interviews. Two groups with patients referred to repair of parastomal bulging and three groups with patients attending the outpatient stoma clinics

Locations

Country	Name	City	State
Denmark	Marianne Krogsgaard	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' experiences of symptoms in relation to parastomal bulging and the impact on everyday life	A funnel-based interview approach will be used, allowing for a less structured, open beginning moving to a more structured ending ensuring that the research question will be answered	1 day	No