A core outcome set for groin hernia trials

Groin hernia is an exceedingly common illness world-wide, and it is a frequent cause of chronic pain, which can be immensely debilitating and cause poor quality of life. Consequently, surgical hernia repair is one of the most frequently performed surgical procedures in the world.

In groin hernia surgery, recurrence has traditionally been the most important outcome to measure, but recently many hernia surgeons and researchers have also gained an increasing interest in patient-reported outcomes, such as chronic pain and quality of life. Thus, there is no current consensus on which outcomes of groin hernia repair are most important, and current outcome reporting in groin hernia trials is inconsistent and heterogenous.

We aim to develop a core outcome set for groin hernia trials through literature review and consensus methodology. This core outcome set will define which outcomes of groin hernia repair are most essential and should be recommended to be reported in all effectiveness trials investigating surgical approaches for groin hernia repair in adults.

Contributors

Dr. Anders Gram-Hanssen, Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, University of Copenhagen, Denmark

Professor Jacob Rosenberg, Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, University of Copenhagen, Denmark

List of contributors will be expanded in the future.

Further Study Information

Current Stage: Ongoing
Date: January 2019 - December 2023
Funding source(s): None


Health Area

Disease Category: Gastroenterology

Disease Name: Hernia

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Surgery

Stakeholders Involved

- Consumers (patients)
- Clinical experts

Study Type

- COS for clinical trials or clinical research

Method(s)

- Systematic review
- Delphi process

Phase 1: Updating a previously published systematic review on outcome reporting in groin hernia trials.
Phase 2: Delphi study to reach consensus among stakeholders on which outcomes are most important.
Phase 3: Consensus discussion in study steering committee and including key stakeholders with the aim of making a final selection of outcomes for the core outcome set.