Clinical trial NCT04138329: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain Post-Procedural
Lead sponsor: Hospital Central "Dr. Ignacio Morones Prieto"
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Postoperative inguinal pain assessed by the Inguinal Pain Questionnaire validated in spanish.
timeFrame: The questionnaire was applied at 1 week after surgery
measure: Postoperative inguinal pain assessed by the Inguinal Pain Questionnaire validated in spanish.
timeFrame: The questionnaire was applied at 1 month after surgery
measure: Postoperative inguinal pain assessed by the Inguinal Pain Questionnaire validated in spanish.
timeFrame: The questionnaire was applied at 3 months after surgery
measure: Postoperative inguinal pain assessed by the Inguinal Pain Questionnaire validated in spanish.
timeFrame: The questionnaire was applied at 6 months after surgery
measure: Postoperative inguinal pain assessed by Numerical Pain Rating Scale
timeFrame: The scale was applied at 1 week after surgery
measure: Postoperative inguinal pain assessed by Numerical Pain Rating Scale
timeFrame: The scale was applied at 1 month after surgery
measure: Postoperative inguinal pain assessed by Numerical Pain Rating Scale
timeFrame: The scale was applied at 3 months after surgery
measure: Postoperative inguinal pain assessed by Numerical Pain Rating Scale
timeFrame: The scale was applied at 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: San Luis Potosí
country: Mexico
facility: Hospital Central Dr. Ignacio Morones Prieto
Study officials:
affiliation: Hospital Central "Dr. Ignacio Morones Prieto"
name: Jorge Aguilar García
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.