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. 2017 Feb;21(1):45-50.
doi: 10.1007/s10029-016-1554-y. Epub 2016 Dec 5.

Patient-reported outcomes (PROs) after total extraperitoneal hernia repair (TEP)

E H H Mommers  1   2 , D R M Hünen  3 , J C H M van Hout  3 , M Guit  4 , J A Wegdam  3 , S W Nienhuijs  5 , T S de Vries Reilingh  3
Affiliations

Patient-reported outcomes (PROs) after total extraperitoneal hernia repair (TEP)

E H H Mommers et al. Hernia. 2017 Feb.

Abstract

Background: Patient-reported outcomes (PROs) such as quality of life (QoL), patient satisfaction, and work impairment, are arguably the most important outcomes of any medical treatment. In 2011, Staerkle and Villiger developed the Core Outcome Measurements Index (COMI) to standardise PROs and PRO measurement for inguinal hernia patients, in an attempt to increase inter-study comparability. The aim of this study is to prospectively evaluate the short- and long-term postoperative QoL, function, patient well-being, pain, and social/work disability, after total extraperitoneal (TEP) inguinal hernia repair and to provide the first clinical experience with the COMI-hernia questionnaire.

Methods: Between January 2013 and December 2014, all patients ≥18 years that were scheduled for elective uni- or bilateral TEP in a regional hospital were approached to participate in this study. Measurements were taken preoperatively, and 6 weeks and 1 year postoperatively.

Results: One hundred and twenty patients (113 men, 7 women), mean age 59 years (SD ±12), completed the follow-up of 1 year. Ninety-seven percent of the population reported that the operation improved their complaints. QoL, function, well-being, and pain all improved after 6 weeks and 1 year after surgery. Patients experienced more social and work-related limitations 6 weeks after surgery compared to baseline measurements, though this improved to normal 1 year postoperatively. The incidence of chronic pain was 14% (VAS ≥ 2), which had a negative impact on the patients' sense of well-being.

Conclusion: Patients recovered well after TEP repair with a good quality of life and fast restore of function. Patient well-being was lower than expected due to a 14% incidence of chronic pain. The COMI-hernia scale provided reasonable insight into the patients' experience, though it was difficult to interpret for both patient and physician.

Keywords: Function; Pain; Patient well-being; Patient-reported outcome (PRO); Quality of life (QoL); Social and work disability; Total extraperitoneal herniorrhaphy (TEP).

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Conflict of interest statement

SN reports grants from Johnson and Johnson, and grants from Medtronic, outside the submitted work. All other authors declare that they have no conflict of interest. Ethical statement All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Statement of human and animal rights This article does not contain any studies with animals performed by any of the authors. Informed consent Informed consent was indeed obtained from all individual participant included in the study.

Figures

Fig. 1
Fig. 1
Flow of patients through the study. Asterisk 12 patients were excluded after inclusion, because the surgeon decided to perform a TAPP, Lichtenstein, or Stoppa repair, despite an initial indication for TEP
Fig. 2
Fig. 2
Main outcome parameters of the COMI-hernia questionnaire. The average main outcome scores of the COMI-hernia questionnaire reported on a ten-point scale. A higher score correlates with a worse outcome. Asterisk score differs statistically significantly from the previous time of measurement; QoL preop. = 3.2 (SD ± 2.0), QoL 6 weeks postop. = 1.6 (SD ± 1.5), QoL 1 year postop. = 0.3 (SD ± 1.2) (pre vs 6 weeks p < 0.001; 6 weeks vs 1 year p < 0.001). Function preop. = 3.2 (SD ± 2.3), Function 6 weeks postop. = 1.0 (SD ± 1.6), Function 1 year postop. = 0.6 (SD ± 1.4) (pre vs 6 weeks p < 0.001; 6 weeks vs 1 year p = 0.017). Well-being preop. = 8.1 (SD ± 3.0), well-being 6 weeks postop. = 2.4 (SD ± 3.2), well-being 1 years postop. = 1.9 (SD ± 3.2) (pre vs 6 weeks p < 0.001; 6 weeks vs 1 year p = 0.337). Pain preop. VAS = 3.5 (SD ± 2.7), pain 6 weeks postop. = 1.0 (SD ± 1.7), pain 1 year postop. = 0.7 (SD ± 1.7) (pre vs 6 weeks p < 0.001; 6 weeks vs 1 year p = 0.017). So&wo disability preop. = 1.2 (SD ± 1.9), so&wo 6 weeks postop. = 2.1 (SD ± 2.6), so&wo 1 years postop. = 0.3 (SD ± 1.0) (pre vs 6 weeks p < 0.001; 6 weeks vs 1 years p < 0.001)
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