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

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

doi:10.1007/s00423-016-1532-y

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

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

^*Corresponding author af dette arbejde

Institut for Klinisk Medicin

13 Citationer (Scopus)

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

Originalsprog	Engelsk
Tidsskrift	Langenbeck's Archives of Surgery
Vol/bind	402
Udgave nummer	2
Sider (fra-til)	213-218
Antal sider	6
ISSN	1435-2443
DOI	https://doi.org/10.1007/s00423-016-1532-y
Status	Udgivet - mar. 2017

Adgang til dokumentet

10.1007/s00423-016-1532-y

Citationsformater

Andresen, K., Burcharth, J., Fonnes, S., Hupfeld, L., Rothman, J. P., Deigaard, S. L., Winther, D., Errebo, M. B., Therkildsen, R., Hauge, D., Sørensen, F. S., Bjerg, J., & Rosenberg, J. (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 Archives of Surgery, 402(2), 213-218. https://doi.org/10.1007/s00423-016-1532-y

Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial. / Andresen, Kristoffer; Burcharth, Jakob; Fonnes, Siv et al.
I: Langenbeck's Archives of Surgery, Bind 402, Nr. 2, 03.2017, s. 213-218.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Andresen, K, Burcharth, J, Fonnes, S, Hupfeld, L, Rothman, JP, Deigaard, SL, Winther, D, Errebo, MB, Therkildsen, R, Hauge, D, Sørensen, FS, Bjerg, J & Rosenberg, J 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 Archives of Surgery, bind 402, nr. 2, s. 213-218. https://doi.org/10.1007/s00423-016-1532-y

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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",

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",

keywords = "Chronic pain, Inguinal hernia, Lichtenstein, ONSTEP, Randomized clinical trial",

author = "Kristoffer Andresen and Jakob Burcharth and Siv Fonnes and Line Hupfeld and Rothman, {Josephine Philip} and Deigaard, {S{\o}ren L} and Dorte Winther and Errebo, {Maj Britt} and Rikke Therkildsen and Dina Hauge and S{\o}rensen, {Fritz S{\o}b{\ae}k} and Jesper Bjerg and Jacob Rosenberg",

year = "2017",

month = mar,

doi = "10.1007/s00423-016-1532-y",

language = "English",

volume = "402",

pages = "213--218",

journal = "Langenbeck's Archives of Surgery",

issn = "1435-2443",

publisher = "Springer",

number = "2",

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TY - JOUR

T1 - Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial

AU - Andresen, Kristoffer

AU - Burcharth, Jakob

AU - Fonnes, Siv

AU - Hupfeld, Line

AU - Rothman, Josephine Philip

AU - Deigaard, Søren L

AU - Winther, Dorte

AU - Errebo, Maj Britt

AU - Therkildsen, Rikke

AU - Hauge, Dina

AU - Sørensen, Fritz Søbæk

AU - Bjerg, Jesper

AU - Rosenberg, Jacob

PY - 2017/3

Y1 - 2017/3

N2 - 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

AB - 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

KW - Chronic pain

KW - Inguinal hernia

KW - Lichtenstein

KW - ONSTEP

KW - Randomized clinical trial

U2 - 10.1007/s00423-016-1532-y

DO - 10.1007/s00423-016-1532-y

M3 - Journal article

C2 - 27837273

AN - SCOPUS:84994759759

SN - 1435-2443

VL - 402

SP - 213

EP - 218

JO - Langenbeck's Archives of Surgery

JF - Langenbeck's Archives of Surgery

IS - 2

ER -

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

Abstract

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