CompletedNot Applicable

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

Mexico40 participantsStarted 2018-09-15

Plain-language 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.

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: The questionnaire was applied at 1 week after surgery

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

Timeframe: The questionnaire was applied at 1 month after surgery

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

Timeframe: The questionnaire was applied at 3 months after surgery

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

Timeframe: The questionnaire was applied at 6 months after surgery

Postoperative inguinal pain assessed by Numerical Pain Rating Scale

Timeframe: The scale was applied at 1 week after surgery

Postoperative inguinal pain assessed by Numerical Pain Rating Scale

Timeframe: The scale was applied at 1 month after surgery

Trial details

NCT IDNCT04138329

SponsorHospital Central "Dr. Ignacio Morones Prieto"

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03-24

View on ClinicalTrials.gov More Chronic Pain Post-Procedural trials