Improving Decisions and Outcomes in Parastomal Hernia Surgery

Condition(s) studied

Study summary

The goal of this observational study is to help improve decisions about planned surgery for parastomal hernia and understand the results of treatment. A parastomal hernia is a bulge that develops around a stoma, an opening in the abdomen created during surgery to allow bowel contents to pass into a bag. These hernias can cause discomfort, problems with stoma care, and reduced quality of life. Surgery may help, but it also carries risks, and the hernia may return.

The study will include approximately 250 patients assessed for parastomal hernia at Bispebjerg Hospital in Denmark. It will include both patients who undergo planned hernia surgery and patients who are managed without surgery.

The main questions are:

What are the short- and long-term results of planned parastomal hernia surgery, including complications, hospital readmissions, further operations, return of the hernia, and quality of life?

How often do patients who are initially not offered planned surgery need emergency hospital care or emergency surgery?

Which patient characteristics, symptoms, and hernia features are associated with treatment decisions and outcomes?

How does quality of life change over time in patients managed with and without surgery?

Participants will receive their usual care. Decisions about treatment will be made by patients and their clinical team independently of study participation. The study does not assign treatments or require additional invasive examinations.

Researchers will collect information from routine clinical assessments, imaging, medical records, and questionnaires. Participants will complete two questionnaires about stoma-related quality of life and general health, called Stoma-QOL and EQ-5D-5L, when they join the study and at subsequent outpatient assessments.

Participants will also be invited to complete the questionnaires at home through secure digital mail. Patients who have not undergone hernia surgery will receive annual invitations starting one year after joining the study. Patients who undergo planned hernia surgery will receive invitations after surgery and annually thereafter. This allows researchers to follow quality of life over time in both groups.

Participants will be followed for up to five years from joining the study. The findings may help clinicians and patients make better-informed decisions about whether to proceed with planned parastomal hernia surgery.

Eligibility

Primary outcome measure(s)

• Rate of hernia recurrence — 5 years
  hernia recurrence following elective parastomal hernia repair

Trial sites (1)

Other trials for the same condition