Informing the design of a clinical trial into umbilical hernia repair

Assessment of Surgeon Treatment Equipoise & Randomisation Opinion to Inform trial Design (ASTEROID)

Registry ID
ISRCTN56702141
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
University of Birmingham
Enrollment
100
Start date
2025-05-01
Completion date
2026-08-31
Last update
2026-08-17

Conditions

Summary

Surgery

Detailed description

Potential participants will attend hospital with an umbilical hernia which is either stuck (non-reducible), is causing bowel blockage (obstructed), or has lost blood supply to its contents (strangulated). They will be booked for an operation by the surgical team. This operation can take place anywhere from immediately to up to a day later, depending on symptoms and competing system pressures. The clinical team will assess patient eligibility and make an initial approach to the patient, outlining study participation. If the patient is interested in discussing the study, the clinical team will introduce the potential participant to the research team who will provide the patient with a patient information sheet and explain the study, highlighting that it will not change their care. The patient will be allowed a period of time to consider participation. After an appropriate period, the research team will return and discuss the study with the patient, answering any questions they may have. If the patient declines participation, relevant information will be recorded on the screening log. If they wish to participate, they will complete a consent form. An email address will be collected for follow-up questionnaires. Following this, the participant will complete two questionnaires, the EQ-5D-5L (generic quality of life) and the Abdominal Hernia Questionnaire (preoperative version). The participant will undergo clinical care as routine, including surgery and hospital discharge. Follow-up questionnaires will be triggered by the central database, and links with reminders to complete will be sent at post-operative day 7 (+/- 2 days), and post-operative day 30 (+/- 7 days). The participant will be asked to complete the EQ-5D-5L a, the Abdominal Hernia Questionnaire (post-operative version), and the Bluebelle wound health questionnaire at each time point. Any reattendance at hospital for readmission, hernia recurrence, or reoperation within 30 days will be noted by the clini

Interventions

Inclusion criteria

Adult patients undergoing emergency open repair of a strangulated, incarcerated, or obstructed umbilical hernia

Exclusion criteria

1. Patients who are pregnant will not be eligible as they have altered abdominal wall biomechanics 2. Patients with cirrhosis will not be eligible due to different disease processes driving outcomes

Locations

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