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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Study protocol

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

Authors: Xiaoli Liu, Qiuyue Ma, Jie Chen, Huiqi Yang

Published in: Trials | Issue 1/2022

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Abstract

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.
Literature
1.
2.
Hakanson B, Lundell L, Rouvelas I, et al. The large hiatal hernia should be acknowledged and respected][J. Lakartidningen. 2018;115:E9PL.PubMed
3.
Borman DA, Sunshein KE, Stigall KS, et al. Clinical and quality of life assessment of patients undergoing laparoscopic hiatal hernia repair[J]. Am Surg. 2019;85(11):1269–75.CrossRefPubMed
4.
Koetje JH, Irvine T, Thompson SK, et al. Quality of life following repair of large hiatal hernia is improved but not influenced by use of mesh: results from a randomized controlled trial[J]. World J Surg. 2015;39(6):1465–73.CrossRefPubMed
5.
Yano F, Tsuboi K, Omura N, et al. Treatment strategy for laparoscopic hiatal hernia repair[J]. Asian J Endosc Surg. 2021;14(4):684–91.CrossRefPubMed
6.
Chen Z, Zhao H, Sun X, et al. Laparoscopic repair of large hiatal hernias: clinical outcomes of 10 years[J]. ANZ J Surg. 2018;88(10):E703–7.CrossRefPubMed
7.
Oor JE, Koetje JH, Roks DJ, et al. Laparoscopic hiatal hernia repair in the elderly patient[J]. World J Surg. 2016;40(6):1404–11.CrossRefPubMed
8.
Nie Y, Xiong Y, Guan L, et al. Laparoscopic fixation of biological mesh at hiatus with glue and suture during hiatal hernia repair[J]. BMC Surg. 2021;21(1):158.CrossRefPubMedPubMedCentral
9.
Hedman A, Eriksson G, von Koch L, et al. Five-year follow-up of a cluster-randomized controlled trial of a client-centred activities of daily living intervention for people with stroke[J]. Clin Rehabil. 2019;33(2):262–76.CrossRefPubMed
10.
Oor JE, Roks DJ, Koetje JH, et al. Randomized clinical trial comparing laparoscopic hiatal hernia repair using sutures versus sutures reinforced with non-absorbable mesh[J]. Surg Endosc. 2018;32(11):4579–89.CrossRefPubMed
11.
Kubiszewski I, Zakariyya N, Costanza R. Objective and subjective indicators of life satisfaction in australia: how well do people perceive what supports a good life?[J]. Ecol Econ. 2018;154:361–72.CrossRef
12.
Lee T, Marans RW. Objective and subjective indicators: Effects of scale discordance on interrelationships[J]. Soc Indic Res. 1980;8(1):47–64.CrossRef
13.
Gisi C, Wang K, Khan F, et al. Efficacy and patient satisfaction of single-session transoral incisionless fundoplication and laparoscopic hernia repair[J]. Surg Endosc. 2021;35(2):921–7.CrossRefPubMed
14.
15.
Ehlers AP, Chhabra K, Thumma JR, et al. In the eye of the beholder: surgeon variation in intra-operative perceptions of hiatal hernia and reflux outcomes after sleeve gastrectomy[J]. Surg Endosc. 2021;35(6):2537–42.CrossRefPubMed
16.
Koetje JH, Oor JE, Roks DJ, et al. Equal patient satisfaction, quality of life and objective recurrence rate after laparoscopic hiatal hernia repair with and without mesh[J]. Surg Endosc. 2017;31(9):3673–80.CrossRefPubMed
17.
18.
19.
Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement[J]. BMJ. 2009;339:b2535.CrossRefPubMedPubMedCentral
20.
Dodd S, Clarke M, Becker L, et al. A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery[J]. J Clin Epidemiol. 2018;96:84–92.CrossRefPubMedPubMedCentral
21.
Suehs CM, Menzies-Gow A, Price D, et al. Expert consensus on the tapering of oral corticosteroids for the treatment of asthma. A Delphi study[J]. Am J Respir Crit Care Med. 2021;203(7):871–81.CrossRefPubMed
22.
Fritzsche JA, Fockens P, Barthet M, et al. Expert consensus on endoscopic papillectomy using a Delphi process[J]. Gastrointest Endosc. 2021;94(4):760–73.CrossRefPubMedPubMedCentral
23.
24.
Carter P, O’Donoghue K, Dworzynski K, et al. A demonstration of using formal consensus methods within guideline development; a case study[J]. BMC Med Res Methodol. 2021;21(1):73.CrossRefPubMedPubMedCentral
25.
Wallace C, Elliott M, Thomas S, et al. Using consensus methods to develop a Social Prescribing Learning Needs Framework for practitioners in Wales[J]. Perspect Public Health. 2021;141(3):136–48.CrossRefPubMed
26.
Tugwell P, Knottnerus JA. The need for consensus on consensus methods[J]. J Clin Epidemiol. 2018;99:vi–viii.CrossRefPubMed
27.
Guyatt GH, Oxman AD, Kunz R, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes[J]. J Clin Epidemiol. 2011;64(4):395–400.CrossRefPubMed
28.
Dribin TE, Schnadower D, Spergel JM, et al. Severity grading system for acute allergic reactions: a multidisciplinary Delphi study[J]. J Allergy Clin Immunol. 2021;148(1):173–81.CrossRefPubMedPubMedCentral
29.
Cross H. A Delphi exercise to refine the WHO three-point disability grading system for leprosy, and to develop guidelines to promote greater accuracy and reliability of WHO disability recording[J]. Lepr Rev. 2014;85(1):18–28.CrossRefPubMed
30.
Shorter GW, Heather N, Bray JW, et al. Prioritization of outcomes in efficacy and effectiveness of alcohol brief intervention trials: international multi-stakeholder e-Delphi consensus study to inform a core outcome Set[J]. J Stud Alcohol Drugs. 2019;80(3):299–309.CrossRefPubMed
31.
Morino M, Giaccone C, Pellegrino L, et al. Laparoscopic management of giant hiatal hernia: factors influencing long-term outcome[J]. Surg Endosc. 2006;20(7):1011–6.CrossRefPubMed
32.
Castelijns P, Ponten J, Van de Poll M, et al. Subjective outcome after laparoscopic hiatal hernia repair for intrathoracic stomach[J]. Langenbecks Arch Surg. 2017;402(3):521–30.CrossRefPubMed
33.
Lei Y, Li JY, Jiang J, et al. Outcome of floppy Nissen fundoplication with intraoperative manometry to treat sliding hiatal hernia[J]. Dis Esophagus. 2008;21(4):364–9.CrossRefPubMed
34.
Blake AM, Mittal SK. Long-term clinical outcomes after intrathoracic stomach surgery: a decade of longitudinal follow-up[J]. Surg Endosc. 2018;32(4):1954–62.CrossRefPubMed
Metadata
Title
A protocol for developing core outcome sets for laparoscopic hiatal hernia repair
Authors
Xiaoli Liu
Qiuyue Ma
Jie Chen
Huiqi Yang
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06845-1

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