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01-03-2017 | Controlled Clinical Trial

Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial

Authors: Kristoffer Andresen, Jakob Burcharth, Siv Fonnes, Line Hupfeld, Josephine Philip Rothman, Søren Deigaard, Dorte Winther, Maj-Britt Errebo, Rikke Therkildsen, Dina Hauge, Fritz Søbæk Sørensen, Jesper Bjerg, Jacob Rosenberg

Published in: Langenbeck's Archives of Surgery | Issue 2/2017

Abstract

Purpose

The open new simplified totally extraperitoneal (ONSTEP) technique for the repair of inguinal hernia was presented some years ago with promising initial results regarding chronic pain. We conducted a randomized clinical trial investigating the ONSTEP technique versus the Lichtenstein technique with focus on postoperative pain. The aim of this paper was to report the results regarding chronic pain from follow-up at 6 and 12 months for the participants in the ONSTEP versus Lichtenstein trial.

Methods

This study was conducted as a randomized double-blinded clinical trial in male participants with primary unilateral hernias, having surgical repair of their hernia at one of five participating general surgical departments. At surgery, participants were allocated (1:1) to the ONSTEP or the Lichtenstein technique for inguinal hernia repair. Participants were followed up with questionnaires at 6 and 12 months. The primary outcome was the proportion of patients with substantial pain-related impairment of daily functions at 6- and 12-month follow-ups.

Results

From April 2013 to May 2014, 290 male patients were included in the study. Regarding follow-up for pain, a total of 259 patients (89%) completed the 6-month follow-up and a total of 236 patients (81%) completed the 12-month follow-up. Regarding pain at the 6- and 12-month follow-ups, no difference was found between groups. Two patients operated with Lichtenstein technique developed severe disabling chronic pain postoperatively, which was not seen in the ONSTEP group.

Conclusion

The ONSTEP technique was not superior to the Lichtenstein technique regarding chronic pain following repair of primary inguinal hernias in males.

Trial registration

https://clinicaltrials.gov NCT01753219

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Title: Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial
Authors: Kristoffer Andresen
Jakob Burcharth
Siv Fonnes
Line Hupfeld
Josephine Philip Rothman
Søren Deigaard
Dorte Winther
Maj-Britt Errebo
Rikke Therkildsen
Dina Hauge
Fritz Søbæk Sørensen
Jesper Bjerg
Jacob Rosenberg
Publication date: 01-03-2017
Publisher: Springer Berlin Heidelberg
Published in: Langenbeck's Archives of Surgery / Issue 2/2017
Print ISSN: 1435-2443
Electronic ISSN: 1435-2451
DOI: https://doi.org/10.1007/s00423-016-1532-y

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial

Abstract

Purpose

Methods

Results

Conclusion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Trial registration

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