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

NCT04138329 | Completed DMC

• 1 other identifier: 48-18
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain Post-Procedural

Outcome Measures

Primary Outcomes (8)

• Postoperative inguinal pain assessed by the Inguinal Pain Questionnaire validated in spanish.

  The inguinal pain questionnaire (IPQ) was developed by U. Fränneby et al. and published in 2008 as a tool to measure pain behavior. Evaluates the current inguinal pain, the worst pain experienced in the last week and interference with daily activities due to pain. There is a total of 18 questions with a duration of less than 10 minutes to complete it. They concluded that the questionnaire produces valid and reliable information on the frequency and severity of inguinal pain. The investigators also validated this survey in spanish so it could be applied in the study population.

  The questionnaire was applied at 1 week after surgery

• Postoperative inguinal pain assessed by the Inguinal Pain Questionnaire validated in spanish.

  The inguinal pain questionnaire (IPQ) was developed by U. Fränneby et al. and published in 2008 as a tool to measure pain behavior. Evaluates the current inguinal pain, the worst pain experienced in the last week and interference with daily activities due to pain. There is a total of 18 questions with a duration of less than 10 minutes to complete it. They concluded that the questionnaire produces valid and reliable information on the frequency and severity of inguinal pain. The investigators also validated this survey in spanish so it could be applied in the study population.

  The questionnaire was applied at 1 month after surgery

• Postoperative inguinal pain assessed by the Inguinal Pain Questionnaire validated in spanish.

  The inguinal pain questionnaire (IPQ) was developed by U. Fränneby et al. and published in 2008 as a tool to measure pain behavior. Evaluates the current inguinal pain, the worst pain experienced in the last week and interference with daily activities due to pain. There is a total of 18 questions with a duration of less than 10 minutes to complete it. They concluded that the questionnaire produces valid and reliable information on the frequency and severity of inguinal pain. The investigators also validated this survey in spanish so it could be applied in the study population.

  The questionnaire was applied at 3 months after surgery

• Postoperative inguinal pain assessed by the Inguinal Pain Questionnaire validated in spanish.

  The inguinal pain questionnaire (IPQ) was developed by U. Fränneby et al. and published in 2008 as a tool to measure pain behavior. Evaluates the current inguinal pain, the worst pain experienced in the last week and interference with daily activities due to pain. There is a total of 18 questions with a duration of less than 10 minutes to complete it. They concluded that the questionnaire produces valid and reliable information on the frequency and severity of inguinal pain. The investigators also validated this survey in spanish so it could be applied in the study population.

  The questionnaire was applied at 6 months after surgery

• Postoperative inguinal pain assessed by Numerical Pain Rating Scale

  This scale is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain, 0 means no pain and 10 the worst pain ever.

  The scale was applied at 1 week after surgery

• Postoperative inguinal pain assessed by Numerical Pain Rating Scale

  This scale is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain, 0 means no pain and 10 the worst pain ever.

  The scale was applied at 1 month after surgery

• Postoperative inguinal pain assessed by Numerical Pain Rating Scale

  This scale is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain, 0 means no pain and 10 the worst pain ever.

  The scale was applied at 3 months after surgery

• Postoperative inguinal pain assessed by Numerical Pain Rating Scale

  This scale is a segmented numeric version of the visual analog scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain, 0 means no pain and 10 the worst pain ever.

  The scale was applied at 6 months after surgery

Study Arms (2)

Lichtenstein Technique

ACTIVE COMPARATOR

In this arm the inguinal hernia repair was made with the Lichtenstein technique by surgeons with experience in this kind of plasty using the conventional polypropylene mesh.

Procedure: Lichtenstein Technique

Onstep Technique

EXPERIMENTAL

In this arm the inguinal hernia repair was made with the Onstep technique by one surgeon with experience using the Bard's 3DMAX mesh.

Procedure: Onstep Technique

Interventions

Lichtenstein Technique PROCEDURE

In this group was used the Lichtenstein technique for inguinal repair

Lichtenstein Technique

Onstep Technique PROCEDURE

In this group was used the Onstep technique for inguinal repair

Onstep Technique

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of unilateral inguinal hernia.
• Male or Female.
• Older tan 16 years.
• Accept to participate in the study.

You may not qualify if:

• Chronic Obstructive Pulmonary Disease.
• Obesity.
• Diabetes Mellitus.
• Cirrhosis.
• Diseases involving collagen deficiency.
• Previous surgery in the groin.

Sponsors & Collaborators

• Hospital Central "Dr. Ignacio Morones Prieto": lead

Study Sites (1)

Hospital Central Dr. Ignacio Morones Prieto

San Luis Potosí City, 78290, Mexico

Location

Related Publications (8)

• Rosenberg J, Andresen K. The Onstep Method for Inguinal Hernia Repair: Operative Technique and Technical Tips. Surg Res Pract. 2016;2016:6935167. doi: 10.1155/2016/6935167. Epub 2016 Jun 9.

  PMID: 27379255 BACKGROUND

• Andresen K, Burcharth J, Fonnes S, Hupfeld L, Rothman JP, Deigaard S, Winther D, Errebo MB, Therkildsen R, Hauge D, Sorensen FS, Bjerg J, Rosenberg J. Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial. Langenbecks Arch Surg. 2017 Mar;402(2):213-218. doi: 10.1007/s00423-016-1532-y. Epub 2016 Nov 11.

  PMID: 27837273 BACKGROUND

• Alfieri S, Amid PK, Campanelli G, Izard G, Kehlet H, Wijsmuller AR, Di Miceli D, Doglietto GB. International guidelines for prevention and management of post-operative chronic pain following inguinal hernia surgery. Hernia. 2011 Jun;15(3):239-49. doi: 10.1007/s10029-011-0798-9. Epub 2011 Mar 2.

  PMID: 21365287 BACKGROUND

• Franneby U, Gunnarsson U, Andersson M, Heuman R, Nordin P, Nyren O, Sandblom G. Validation of an Inguinal Pain Questionnaire for assessment of chronic pain after groin hernia repair. Br J Surg. 2008 Apr;95(4):488-93. doi: 10.1002/bjs.6014.

  PMID: 18161900 BACKGROUND

• Lourenco A, da Costa RS. The ONSTEP inguinal hernia repair technique: initial clinical experience of 693 patients, in two institutions. Hernia. 2013 Jun;17(3):357-64. doi: 10.1007/s10029-013-1057-z. Epub 2013 Feb 24.

  PMID: 23435639 BACKGROUND

• Aasvang E, Kehlet H. Chronic postoperative pain: the case of inguinal herniorrhaphy. Br J Anaesth. 2005 Jul;95(1):69-76. doi: 10.1093/bja/aei019. Epub 2004 Nov 5. No abstract available.

  PMID: 15531621 BACKGROUND

• Browne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995 Sep 15;14(17):1933-40. doi: 10.1002/sim.4780141709.

  PMID: 8532986 BACKGROUND

• Aguilar-Garcia J, Villafuerte-Fernandez R, Ntezes-Hidalgo PI, Meade-Aguilar JA, Ramirez-GarciaLuna JL, Martinez-Jimenez MA. Postoperative inguinal pain and disability after Lichtenstein versus ONSTEP hernia repair: analysis of responses to the inguinal pain questionnaire in Spanish. Surg Today. 2021 May;51(5):703-712. doi: 10.1007/s00595-020-02155-8. Epub 2020 Oct 11.

  PMID: 33040236 DERIVED

Study Officials

• Jorge Aguilar García

  Hospital Central "Dr. Ignacio Morones Prieto"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon at the General Surgery Department

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 24, 2019
• Study Start: September 15, 2018
• Primary Completion: March 24, 2019
• Study Completion: September 24, 2019
• Last Updated: October 24, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)