Clinical trial NCT02889536: Living With a Parastomal Bulge - a Phenomenological-hermeneutic Study of Patients Lived Experiences
Official title: Living With a Parastomal Bulge - a Phenomenological-hermeneutic Study of Patients Lived Experiences
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ostomy
Hernia
Signs and Symptoms
Keywords: parastomal hernia
ostomy
qualitative
phenomenological-hermeneutic research
symptoms
parastomal bulging
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
First posted: 2016-09-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stoma patients that are routinely followed for at least one year post surgery by stoma care nurses (SCNs) at the outpatient stoma clinics at the five hospitals within the region.

Brief 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.

Detailed 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)

Eligibility criteria: 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

Primary outcomes:
measure: Patients' experiences of symptoms in relation to parastomal bulging and the impact on everyday life
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Marianne Krogsgaard
Study officials:
affiliation: Abdominal Centre, Rigshospitalet, Copenhagen Denmark
name: Thordis Thomsen, PhD, RN
role: STUDY_CHAIR
References: