OstomyNCT02889536
Living With a Parastomal Bulge - a Phenomenological-hermeneutic Study of Patients Lived Experiences
An observational study of Ostomy and Hernia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ostomy, Hernia, Signs and Symptoms
- What is being tested?
- Focus group interviews
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2016to Oct 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Permanent or temporary active sigmoidostomy, transversostomy, jejunostomy or ileostomy
- PB diagnosed by stoma care nurse
- Ability to speak and understand Danish
Who cannot join
- Previous surgical repair for PB
- Major incisional abdominal hernias
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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)
- Conditions
- Ostomy, Hernia, Signs and Symptoms
- Being tested
- Focus group interviews
- Keywords
- parastomal hernia, ostomy, qualitative, phenomenological-hermeneutic research, symptoms, parastomal bulging
- Medical subject headings
- Hernia, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus group interviewsOther
Also called Qualitative data collection
Focus group interviews. Two groups with patients referred to repair of parastomal bulging and three groups with patients attending the outpatient stoma clinics
| Study group | Role | What they receive |
|---|---|---|
| Focus group interview, stoma clinics | Qualitative data collection. Patients attending stoma clinics in the capital region Receives: Other: Focus group interviews | |
| Focus group interview, referred | Qualitative data collection. Patients referred to repair surgery at a specific hospital in the capital region Receives: Other: Focus group interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OstomyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital
- Responsible party
- Principal investigator, Marianne Krogsgaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Thordis Thomsen, PhD, RN, Study chair, Abdominal Centre, Rigshospitalet, Copenhagen Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889536
- Sponsor's protocol ID
- PreParE-qualitative
- Status last verified
- Oct 2016
- First submitted
- 30 Aug 2016
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living With a Parastomal Bulge - a Phenomenological-hermeneutic Study of Patients Lived Experiences
- ClinicalTrials.gov ID
- NCT02889536
- Acronym / sponsor ID
- PreParE-qualitative
- Conditions
- Ostomy, Hernia, Signs and Symptoms
- Keywords
- parastomal hernia, ostomy, qualitative, phenomenological-hermeneutic research, symptoms, parastomal bulging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Herlev Hospital
- Study start
- Jun 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focus group interview, stoma clinics | – | Other: Focus group interviewsQualitative data collection. Patients attending stoma clinics in the capital region |
| Focus group interview, referred | – | Other: Focus group interviewsQualitative data collection. Patients referred to repair surgery at a specific hospital in the capital region |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Permanent or temporary active sigmoidostomy, transversostomy, jejunostomy or ileostomy
- PB diagnosed by stoma care nurse
- Ability to speak and understand Danish
Key exclusion criteria (2 listed)
- Previous surgical repair for PB
- Major incisional abdominal hernias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus group interviewsAlso: Qualitative data collectionFocus group interviews. Two groups with patients referred to repair of parastomal bulging and three groups with patients attending the outpatient stoma clinics | Other | Focus group interview, referred, Focus group interview, stoma clinics |
Primary outcome
Patients' experiences of symptoms in relation to parastomal bulging and the impact on everyday life
Time frame: 1 day
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Ostomy
Recruiting
Conducting Wound, Ostomy, and Continence (WOC) Nurse Telephone Follow-up for Post-discharge Ostomy Patients to Reduce Hospital Readmission
Ostomy
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Active, not recruiting
The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
Ostomy - Ileostomy or Colostomy
Recruiting
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Ostomy, Enterocutaneous Fistula
Active, not recruiting
ColoSeal™ ICD System Anastomotic Protection Pivotal Study
Rectal Cancer Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thordis Thomsen, PhD, RN study chair
Abdominal Centre, Rigshospitalet, Copenhagen Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ostomy and Hernia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 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: finished, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' experiences of symptoms in relation to parastomal bulging and the impact on everyday life (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2016.