Skip to main content
Top
Published in: Hernia 3/2022

04-09-2021 | Inguinal Hernia | Review

Results from patient-reported outcome measures are inconsistently reported in inguinal hernia trials: a systematic review

Authors: A. Gram-Hanssen, C. Christophersen, J. Rosenberg

Published in: Hernia | Issue 3/2022

Login to get access

Abstract

Purpose

To evaluate the use, results, and reporting of patient-reported outcome measures specific to patients undergoing inguinal hernia repair.

Methods

A systematic review was performed and reported according to the PRISMA 2020 statement. A protocol was registered at PROSPERO (CRD42021243468). Systematic searches were performed in PubMed and EMBASE. We only included randomized controlled trials that involved postoperative administration of a hernia-specific patient-reported outcome measure. Risk of bias was evaluated with the Cochrane risk of bias-tool 2.0.

Results

Twenty trials and four different instruments were included: the Carolinas Comfort Scale (nine studies), Activities Assessment Scale (six studies), Inguinal Pain Questionnaire (seven studies), and Surgical Pain Scales (one study). Included trials used patient-reported outcome measures and compared either different surgical approaches (11 studies), types of mesh/fixation (seven studies), or types of anesthesia/analgesia (two studies). Results were reported using several different methods including means, medians, or proportions of either overall results, results from subscales, or results from single questionnaire items. Seven of the 20 included studies specified a patient-reported outcome measure as a primary outcome and provided clear reporting of sample size calculation.

Conclusion

Reporting of results from patient-reported outcome measures in inguinal hernia research was characterized by heterogeneity. The results were reported using several different methods, which impedes proper evidence synthesis. Only half of the included studies applied a patient-reported outcome measure as primary outcome. Ultimately, the heterogeneity in outcome reporting is an important methodological problem obstructing the full utilization of patient-reported outcome measures in inguinal hernia research.
Literature
11.
go back to reference Higgins J, Savović J, Page M, Elbers R, Sterne J (2021) Chapter 8: Assessing risk of bias in a randomized trial. In: Higgins J, Thomas J, Chandler J, Cumpston P, Li T, Page M, Welch V (eds) Cochrane handbook for systematic reviews of interventions version 6.2. Cochrane Higgins J, Savović J, Page M, Elbers R, Sterne J (2021) Chapter 8: Assessing risk of bias in a randomized trial. In: Higgins J, Thomas J, Chandler J, Cumpston P, Li T, Page M, Welch V (eds) Cochrane handbook for systematic reviews of interventions version 6.2. Cochrane
12.
go back to reference Aguilar-García J, Villafuerte-Fernandez R, Ntezes-Hidalgo PI, Meade-Aguilar JA, Ramirez-GarciaLuna JL, Martinez-Jimenez MA (2020) Postoperative inguinal pain and disability after Lichtenstein versus ONSTEP hernia repair: analysis of responses to the inguinal pain questionnaire in Spanish. Surg Today. https://doi.org/10.1007/s00595-020-02155-8 (Epub ahead of print)CrossRefPubMed Aguilar-García J, Villafuerte-Fernandez R, Ntezes-Hidalgo PI, Meade-Aguilar JA, Ramirez-GarciaLuna JL, Martinez-Jimenez MA (2020) Postoperative inguinal pain and disability after Lichtenstein versus ONSTEP hernia repair: analysis of responses to the inguinal pain questionnaire in Spanish. Surg Today. https://​doi.​org/​10.​1007/​s00595-020-02155-8 (Epub ahead of print)CrossRefPubMed
13.
go back to reference Andresen K, Burcharth J, Fonnes S, Hupfeld L, Rothman JP, Deigaard S, Winther D, Errebo MB, Therkildsen R, Hauge D et al (2017) Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial. Langenbeck’s Arch Surg 402:213–218. https://doi.org/10.1007/s00423-016-1532-yCrossRef Andresen K, Burcharth J, Fonnes S, Hupfeld L, Rothman JP, Deigaard S, Winther D, Errebo MB, Therkildsen R, Hauge D et al (2017) Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial. Langenbeck’s Arch Surg 402:213–218. https://​doi.​org/​10.​1007/​s00423-016-1532-yCrossRef
18.
go back to reference Denham M, Johnson B, Leong M, Kuchta K, Conaty E, Ujiki MB, Denham W, Haggerty SP, Butt Z, Carbray J et al (2019) An analysis of results in a single-blinded, prospective randomized controlled trial comparing non-fixating versus self-fixating mesh for laparoscopic inguinal hernia repair. Surg Endosc 33:2670–2679. https://doi.org/10.1007/s00464-018-6555-8CrossRefPubMed Denham M, Johnson B, Leong M, Kuchta K, Conaty E, Ujiki MB, Denham W, Haggerty SP, Butt Z, Carbray J et al (2019) An analysis of results in a single-blinded, prospective randomized controlled trial comparing non-fixating versus self-fixating mesh for laparoscopic inguinal hernia repair. Surg Endosc 33:2670–2679. https://​doi.​org/​10.​1007/​s00464-018-6555-8CrossRefPubMed
20.
23.
go back to reference Lydeking L, Johansen N, Oehlenschläger J, Bay-Nielsen M, Bisgaard T (2020) Re-recurrence and pain 12 years after laparoscopic transabdominal preperitoneal (TAPP) or Lichtenstein’s repair for a recurrent inguinal hernia: a multi-centre single-blinded randomised clinical trial. Hernia 24:787–792. https://doi.org/10.1007/s10029-020-02139-0CrossRefPubMed Lydeking L, Johansen N, Oehlenschläger J, Bay-Nielsen M, Bisgaard T (2020) Re-recurrence and pain 12 years after laparoscopic transabdominal preperitoneal (TAPP) or Lichtenstein’s repair for a recurrent inguinal hernia: a multi-centre single-blinded randomised clinical trial. Hernia 24:787–792. https://​doi.​org/​10.​1007/​s10029-020-02139-0CrossRefPubMed
25.
29.
go back to reference Singh S, Anand A, Kumar A, Pal AK, Agrawal MK, Kumar S, Pahwa HS, Sonkar AA (2021) A prospective randomised control trial to compare the perioperative outcomes and ergonomic challenges between triangular versus midline port placement in total extra-peritoneal repair of uncomplicated unilateral inguinal hernia. Surg Endosc 35:1395–1404. https://doi.org/10.1007/s00464-020-07525-4CrossRefPubMed Singh S, Anand A, Kumar A, Pal AK, Agrawal MK, Kumar S, Pahwa HS, Sonkar AA (2021) A prospective randomised control trial to compare the perioperative outcomes and ergonomic challenges between triangular versus midline port placement in total extra-peritoneal repair of uncomplicated unilateral inguinal hernia. Surg Endosc 35:1395–1404. https://​doi.​org/​10.​1007/​s00464-020-07525-4CrossRefPubMed
32.
go back to reference Burgmans JPJ, Voorbrood CEH, Simmermacher RKJ, Schouten N, Smakman N, Clevers GJ, Davids PHP, Verleisdonk EJMM, Hamaker ME, Lange JF et al (2016) Long-term results of a randomized double-blinded prospective trial of a lightweight (ultrapro) versus a heavyweight mesh (prolene) in laparoscopic total extraperitoneal inguinal hernia repair (TULP-trial). Ann Surg 263:862–866. https://doi.org/10.1097/SLA.0000000000001579CrossRefPubMed Burgmans JPJ, Voorbrood CEH, Simmermacher RKJ, Schouten N, Smakman N, Clevers GJ, Davids PHP, Verleisdonk EJMM, Hamaker ME, Lange JF et al (2016) Long-term results of a randomized double-blinded prospective trial of a lightweight (ultrapro) versus a heavyweight mesh (prolene) in laparoscopic total extraperitoneal inguinal hernia repair (TULP-trial). Ann Surg 263:862–866. https://​doi.​org/​10.​1097/​SLA.​0000000000001579​CrossRefPubMed
35.
go back to reference Johnston B, Patrick D, Devji T, Maxwell L, Bingham III C, Beaton D, Boers M, Briel M, Busse J, Carrasco-Labra A et al (2021) Chapter 18: Patient-reported outcomes. In: Higgins J, Thomas J, Chandler J, Cumpston P, Li T, Page M, Welch V (eds) Cochrane handbook for systematic reviews of interventions version 6.2. Cochrane Johnston B, Patrick D, Devji T, Maxwell L, Bingham III C, Beaton D, Boers M, Briel M, Busse J, Carrasco-Labra A et al (2021) Chapter 18: Patient-reported outcomes. In: Higgins J, Thomas J, Chandler J, Cumpston P, Li T, Page M, Welch V (eds) Cochrane handbook for systematic reviews of interventions version 6.2. Cochrane
Metadata
Title
Results from patient-reported outcome measures are inconsistently reported in inguinal hernia trials: a systematic review
Authors
A. Gram-Hanssen
C. Christophersen
J. Rosenberg
Publication date
04-09-2021
Publisher
Springer Paris
Keyword
Inguinal Hernia
Published in
Hernia / Issue 3/2022
Print ISSN: 1265-4906
Electronic ISSN: 1248-9204
DOI
https://doi.org/10.1007/s10029-021-02492-8

Other articles of this Issue 3/2022

Hernia 3/2022 Go to the issue