Hernia Clinical Trial
Official title:
Living With a Parastomal Bulge - a Phenomenological-hermeneutic Study of Patients Lived Experiences
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.
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)
;
N/A
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01629485 -
Part vs Whole Task Mastery Training for Laparoscopic Hernia Repair
|
N/A | |
Terminated |
NCT01305486 -
A Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation
|
N/A | |
Completed |
NCT01205399 -
A Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft
|
N/A | |
Completed |
NCT01141335 -
Polypropylene Mesh Versus Polytetrafluoroethylene (PTFE) Mesh in Inguinal Hernia Repair
|
Phase 4 | |
Completed |
NCT00905320 -
Hernia Repair With or Without Sutures
|
N/A | |
Completed |
NCT00617357 -
Repair of Infected or Contaminated Hernias
|
N/A | |
Completed |
NCT00535990 -
Minimally Invasive Surgery (MIS) Database for the Purpose of Research
|
||
Withdrawn |
NCT00138957 -
Study of a New Laparoscopic Technique for Parastomal Hernia Repair With Mesh
|
N/A | |
Completed |
NCT06034652 -
T-GENVIH-003 LTFU (Long Term Follow Up) Study
|
||
Completed |
NCT06389331 -
Study on Effects of Defect Closure in Laparoscopic Repair of Direct Inguinal Hernia
|
||
Completed |
NCT04119466 -
Stabilizing Training in Degenerative Disc Disease
|
N/A | |
Completed |
NCT00622583 -
International Hernia Mesh Registry
|
||
Completed |
NCT04137172 -
Short Term Outcomes of Laparoscopic Intraperitoneal Onlay Mesh With Facial Repair(IPOM-plus) for Ventral Hernia.
|
N/A | |
Completed |
NCT01132209 -
Suture Techniques to Reduce the Incidence of The inCisional Hernia
|
N/A | |
Completed |
NCT00032448 -
Does Tension-Free Herniorrhaphy or Laparoscopic Herniorrhaphy Achieve Equal or Better Recurrence Rates and Lower Costs While Achieving Equivalent Outcomes for Hernia Patients?
|
Phase 3 | |
Not yet recruiting |
NCT05061589 -
Incidence and Risk Factors of Parastomal Hernia in Patients With Permanent Colostomy in China
|
||
Active, not recruiting |
NCT02439060 -
PUBMIC (Prophylactic Use of Biologic Mesh in Ileal Conduit)
|
N/A | |
Completed |
NCT01727388 -
Informativeness to Digital Rectal Examination
|
Phase 3 | |
Completed |
NCT02238964 -
Reinforcement of Closure of Stoma Site
|
Phase 2/Phase 3 | |
Completed |
NCT01997619 -
Biological Mesh Repair of Complex Hernias in High Risk Patients
|
N/A |