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

Chronic Pain Post-Procedural Clinical Trial

Official title:

Comparison of Postoperative Inguinal Pain Between the Onstep Technique and the Lichtenstein Technique: A Randomized Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04138329
• Other study ID #: 48-18
• Status: Completed
• Phase: N/A
• Start date: September 15, 2018
• Est. completion date: September 24, 2019

Study information

• Verified date: October 2019
• Source: Hospital Central "Dr. Ignacio Morones Prieto"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 24, 2019
• Est. primary completion date: March 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Post-Procedural

Intervention

Procedure:
• Lichtenstein Technique
In this group was used the Lichtenstein technique for inguinal repair
• Onstep Technique
In this group was used the Onstep technique for inguinal repair

Locations

Country	Name	City	State
Mexico	Hospital Central Dr. Ignacio Morones Prieto	San Luis Potosí

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Central "Dr. Ignacio Morones Prieto"

Country where clinical trial is conducted

Mexico, 

References & Publications (7)

Aasvang E, Kehlet H. Chronic postoperative pain: the case of inguinal herniorrhaphy. Br J Anaesth. 2005 Jul;95(1):69-76. Epub 2004 Nov 5. Review. — View 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. — View Citation

Andresen K, Burcharth J, Fonnes S, Hupfeld L, Rothman JP, Deigaard S, Winther D, Errebo MB, Therkildsen R, Hauge D, Sørensen 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. — View Citation

Browne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995 Sep 15;14(17):1933-40. — View Citation

Fränneby U, Gunnarsson U, Andersson M, Heuman R, Nordin P, Nyrén 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. — View Citation

Lourenço 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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