A protocol for developing core outcome sets for laparoscopic hiatal hernia repair

Background: Hiatal hernias negatively damage patients' health and life quality. Laparoscopic hiatal hernia repair is currently the gold standard for the treatment of hiatal hernia (LHHR). Numerous clinical trials on laparoscopic hiatal hernia repair have been done, but the published findings are highly variable due to the lack of unique outcome sets. Basic outcome sets have ever been established over the previous decade for a few procedures, but not for hiatal hernia repair yet. This protocol outlines the procedure to develop a core outcome set for laparoscopic hiatal hernia repair COS-LHHR). COS-LHHR will provide a unique criteria for clinical investigations.

Methods: This study will be conducted in four phases: (1) scoping reviews of existing qualitative studies and outcome reporting in randomized controlled trials to develop a list of potential outcome domains; (2) qualitative interviews with patients to explore the impact of laparoscopic hiatal hernia repair and the outcomes that they care most; (3) a multi-round e-Delphi study to achieve preliminary consensus on the core outcome set; and (4) an evidence-based consensus on a core outcome set will be achieved through a structured group consensus meeting, recommending best assessment outcome sets.

Discussion: The development the COS-LHHR will guide clinical research of laparoscopic hiatal hernia repair with unique outcome assessment. This would improve comparative analyses among studies.


The purpose of this study is to provide a set of evidence-based, consensus-based core outcomes that can be used in all studies evaluating the efficacy of laparoscopic hiatal hernia repair


Xiaoli Liu, Qiuyue Ma, Jie Chen, Huiqi Yang


Journal: Trials
Volume: 23
Issue: 1
Pages: 907 -
Year: 2022
DOI: 10.1186/s13063-022-06845-1

Further Study Information

Current Stage: Ongoing
Funding source(s): None

Health Area

Disease Category: Gastroenterology

Disease Name: Hiatal Hernia

Target Population

Age Range: 18 - 80

Sex: Either

Nature of Intervention: Surgery

Stakeholders Involved

Study Type

- COS for clinical trials or clinical research


Linked Studies

Related Links

    No related links