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NCT04138329

Comparison of Postoperative Inguinal Pain Between the Onstep Technique and the Lichtenstein Technique

Completed NA Last updated 24 October 2019
What this trial tests

NA trial testing Lichtenstein Technique in Chronic Pain Post-Procedural in 40 participants. Completed in 24 September 2019.

Timeline
15 September 2018
Primary endpoint
24 March 2019
24 September 2019

Quick facts

Lead sponsorHospital Central "Dr. Ignacio Morones Prieto"
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeother
Enrollment40
Start date15 September 2018
Primary completion24 March 2019
Estimated completion24 September 2019
Sites1 location across Mexico

Drugs / interventions tested

Conditions studied

Sponsor

Hospital Central "Dr. Ignacio Morones Prieto"

Who can join

16 and older, any sex, with Chronic Pain Post-Procedural. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized, double blind, controlled study. The aim is to compare postoperative inguinal pain using the Inguinal Pain Questionnaire (IPQ) validated in Spanish and Numerical Pain Scale in postoperative patients with Lichtenstein and Onstep technique at 1 week, 1, 3 and 6 months. The investigators also validated the IPQ in spanish. It was randomized 20 patients for the Lichtenstein repair and 20 patients for the Onstep technique. The study was conducted in the General Surgery Department of the Central Hospital Dr. Ignacio Morones Prieto, considered as a second level of attention and a surgery training center. The validated questionnaire in spanish and the visual pain scale were applied in the office at 1 week and by phone at 1 month, 3 and 6 months after surgery by two evaluators who did not know the surgical technique used.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Postoperative inguinal pain and disability after Lichtenstein versus ONSTEP hernia repair: analysis of responses to the inguinal pain questionnaire in Spanish.
    Aguilar-García J, Villafuerte-Fernandez R, Ntezes-Hidalgo PI, Meade-Aguilar JA, et al · · 2021 · cited 4× · PMID 33040236 · DOI 10.1007/s00595-020-02155-8

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