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

Primary Purpose

Chronic Pain Post-Procedural

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Lichtenstein Technique
Onstep Technique
Sponsored by
Hospital Central "Dr. Ignacio Morones Prieto"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Pain Post-Procedural

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Hospital Central Dr. Ignacio Morones Prieto

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lichtenstein Technique

Onstep Technique

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 21, 2019
Last Updated
October 22, 2019
Sponsor
Hospital Central "Dr. Ignacio Morones Prieto"
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1. Study Identification

Unique Protocol Identification Number
NCT04138329
Brief Title
Comparison of Postoperative Inguinal Pain Between the Onstep Technique and the Lichtenstein Technique
Official Title
Comparison of Postoperative Inguinal Pain Between the Onstep Technique and the Lichtenstein Technique: A Randomized Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
March 24, 2019 (Actual)
Study Completion Date
September 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Central "Dr. Ignacio Morones Prieto"

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The investigators use the Browne method to estimate the number of patients required for the study. It was applied simple randomization of 40 patients in two groups, the first one consists of 20 patients for the Lichtenstein repair and the second group of 20 patients for Onstep repair. The Onstep procedure was performed by a surgeon skilled in the technique as described in the original article by Rosenberg and 3DMAXTM mesh by Bard was used. The technique is simple, the duration of the surgery is short and consists of a series of standardized steps. It combines an anterior with a preperitoneal approach, consisting of making a lateral incision to the rectus abdominis muscle and above the inguinal canal. It is dissected to a plane between the external and internal oblique fascia, the spermatic cord is dissected and sac reduction is performed, either directly or indirectly. The transversalis fascia is incised and the preperitoneal space is dissected. The mesh is preformed laterally to reinforce the deep inguinal ring and medially accommodates in the previously dissected preperitoneal space. The mesh was fixed to the Cooper's ligament, the pubic tubercle and the rectus abdominis muscle with 2-0 polypropylene suture. The Lichtenstein technique was performed by different surgeons and regular polypropylene mesh was used. 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. Statistical analysis of the results of the survey and visual pain scale in patients operated with the Onstep and Lichtenstein technique was performed with Student's t test and Fisher's exact test. For the validation of the Inguinal Pain Questionnaire in our population the English-Spanish translation of the IPQ was carried out. Then the translation from Spanish to English was made by a person with English proficiency adjusting the initial translation. All postoperative patients with unilateral inguinal plasty, older than 16 years, with Lichtenstein or laparoscopic technique (TEP and TAPP), performed by different surgeons were included. The survey was applied in Spanish and numerical scale of pain to 21 patients who met the inclusion criteria, operated at the Central Hospital "Dr. Ignacio Morones Prieto", a week and a month after surgery. The first survey was conducted in the first week after surgery, the second was applied by telephone 4 weeks later, both performed by evaluators familiarized with the survey and unrelated to the knowledge of the surgical technique used. Analysis of the survey data was carried out using Cronbach's alpha for internal validation, re-test with the Spearman's rho to compare the variability of the responses with time and finally, the answers of the survey were compared with the score of the numerical scale of pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain Post-Procedural

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lichtenstein Technique
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Onstep Technique
Arm Type
Experimental
Arm Description
In this arm the inguinal hernia repair was made with the Onstep technique by one surgeon with experience using the Bard's 3DMAX mesh.
Intervention Type
Procedure
Intervention Name(s)
Lichtenstein Technique
Intervention Description
In this group was used the Lichtenstein technique for inguinal repair
Intervention Type
Procedure
Intervention Name(s)
Onstep Technique
Intervention Description
In this group was used the Onstep technique for inguinal repair
Primary Outcome Measure Information:
Title
Postoperative inguinal pain assessed by the Inguinal Pain Questionnaire validated in spanish.
Description
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.
Time Frame
The questionnaire was applied at 1 week after surgery
Title
Postoperative inguinal pain assessed by the Inguinal Pain Questionnaire validated in spanish.
Description
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.
Time Frame
The questionnaire was applied at 1 month after surgery
Title
Postoperative inguinal pain assessed by the Inguinal Pain Questionnaire validated in spanish.
Description
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.
Time Frame
The questionnaire was applied at 3 months after surgery
Title
Postoperative inguinal pain assessed by the Inguinal Pain Questionnaire validated in spanish.
Description
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.
Time Frame
The questionnaire was applied at 6 months after surgery
Title
Postoperative inguinal pain assessed by Numerical Pain Rating Scale
Description
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.
Time Frame
The scale was applied at 1 week after surgery
Title
Postoperative inguinal pain assessed by Numerical Pain Rating Scale
Description
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.
Time Frame
The scale was applied at 1 month after surgery
Title
Postoperative inguinal pain assessed by Numerical Pain Rating Scale
Description
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.
Time Frame
The scale was applied at 3 months after surgery
Title
Postoperative inguinal pain assessed by Numerical Pain Rating Scale
Description
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.
Time Frame
The scale was applied at 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of unilateral inguinal hernia. Male or Female. Older tan 16 years. Accept to participate in the study. Exclusion Criteria: Chronic Obstructive Pulmonary Disease. Obesity. Diabetes Mellitus. Cirrhosis. Diseases involving collagen deficiency. Previous surgery in the groin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Aguilar García
Organizational Affiliation
Hospital Central "Dr. Ignacio Morones Prieto"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Central Dr. Ignacio Morones Prieto
City
San Luis Potosí
ZIP/Postal Code
78290
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27379255
Citation
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.
Results Reference
background
PubMed Identifier
27837273
Citation
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.
Results Reference
background
PubMed Identifier
21365287
Citation
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.
Results Reference
background
PubMed Identifier
18161900
Citation
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.
Results Reference
background
PubMed Identifier
23435639
Citation
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.
Results Reference
background
PubMed Identifier
15531621
Citation
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.
Results Reference
background
PubMed Identifier
8532986
Citation
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.
Results Reference
background
PubMed Identifier
33040236
Citation
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.
Results Reference
derived

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

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