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

NCT02889536 | Completed

• 1 other identifier: PreParE-qualitative
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ostomy; Hernia; Signs and Symptoms

Keywords

parastomal hernia; ostomy; qualitative; phenomenological-hermeneutic research; symptoms; parastomal bulging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Focus group interview, stoma clinics

Qualitative data collection. Patients attending stoma clinics in the capital region

Other: Focus group interviews

Focus group interview, referred

Qualitative data collection. Patients referred to repair surgery at a specific hospital in the capital region

Other: Focus group interviews

Interventions

Focus group interviews OTHER

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

Also known as: Qualitative data collection

Focus group interview, referred; Focus group interview, stoma clinics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Permanent or temporary active sigmoidostomy, transversostomy, jejunostomy or ileostomy
• PB diagnosed by stoma care nurse
• Ability to speak and understand Danish

You may not qualify if:

• Previous surgical repair for PB
• Major incisional abdominal hernias

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Herlev Hospital: collaborator

Study Sites (1)

Marianne Krogsgaard

Copenhagen, Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Hernia; Signs and Symptoms

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Thordis Thomsen, PhD, RN

  Abdominal Centre, Rigshospitalet, Copenhagen Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, MHS

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 5, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 21, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)