The development of a Core Outcome Set in Hiatal Hernia Repair

A hiatal hernia occurs when the stomach or abdominal viscera herniate from the abdominal cavity into the thoracic cavity via the esophageal hiatus. When symptoms do appear, they are typically vague and intermittent epigastric and substernal pain or discomfort. Patients with large hernias may experience early satiety, dysphagia, or regurgitation. Acute incarceration or volvulus, on the other hand, may cause tissue ischemia, resulting in necrosis and signs of systemic sepsis. To some extent, these conditions endanger patients' health and have an impact on their quality of life. Laparoscopic hiatal hernia repair is currently thought to be the gold standard for the treatment of hiatal hernia, and conservative treatment has no discernible effect. The evaluation of perioperative and postoperative clinical effects during treatment is no longer based solely on the incidence of complications. The most recent international advances and concepts place a greater emphasis on the improvement of patients' symptoms and the restoration of digestive function. There are no metrics for systematic evaluation. Currently, objective indicators such as esophageal manometry, esophageography, gastroscopy, esophageal PH value monitoring, and so on are used to assess clinical effect. However, whether the patient is satisfied with the treatment effect, postoperative diet and nursing, and so on, are all factors to consider. There is a scarcity of relevant indicators, such as subjective indicators of status and subjective problems that are truly concerned in the diagnosis and treatment process. The key to the study is the patient self-reported outcome indicators, which directly reflect the patient's personal feelings about the treatment process and effect, under the concept of building a hospital service organization system of "patient-centered treatment."

The aim of this project is to create a COS of clinically important, patient-oriented outcomes that will be used to guide future research in hiatal hernia reporting.

Contributors

Liu Xiaoli, Department of Hernia and Abdominal Wall Surgery, Beijing Chao-Yang Hospital, Capital Medical University;
Chen Jie, Department of Hernia and Abdominal Wall Surgery, Beijing Chao-Yang Hospital, Capital Medical University;
Shen Yingmo, Department of Hernia and Abdominal Wall Surgery, Beijing Chao-Yang Hospital, Capital Medical University;
Yang Huiqi, Department of Hernia and Abdominal Wall Surgery, Beijing Chao-Yang Hospital, Capital Medical University

Further Study Information

Current Stage: Ongoing
Date: May 2022 - December 2025
Funding source(s): No funding sources


Health Area

Disease Category: Gastroenterology

Disease Name: Hiatal Hernia

Target Population

Age Range: 18 - 80

Sex: Either

Nature of Intervention: Surgery

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Methodologists
- Researchers

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus meeting
- Delphi process
- Interview
- Literature review
- Systematic review

To develop a COS for use in complex hiatal hernia, a mixed-methods study will be conducted in accordance with Core Outcome Measures in Effectiveness Trials (COMET) guidelines. Phase I will consist of a systematic review of the current literature to identify current clinical and patient-reported outcomes that have been reported. Phase II will include in-depth qualitative interviews with patients and other key stakeholders who are underrepresented in the literature in order to identify important outcomes. Phase III will include two to three Delphi studies. Phase III will identify important outcomes that should be included in a COS. Phase IV will consist of a consensus meeting to determine the final COS for hiatal hernia repair.