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OpenTrials
Completed

NCT Number: NCT04839848

Chronic Postoperative Pain After the Lichtenstein Groin Hernioplasty

The study attempts to quantify the relative risks for chronic postoperative inguinal pain (CPIP) after Lichtenstein repair of groin hernia, depending on mesh type and fixation suture material.

For this purpose the investigators will analyze data from the Swedish Hernia Registry (SHR).

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Key information

Conditions

Hernia, Inguinal Chronic Pain Hernia Hernia, Abdominal Hernia, Femoral Neurologic Manifestations PROM Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Suture Related Complication

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This is an open cohort study design where the investigators will analyze existing data that have been prospectively collected in SHR, which covers > 95% of all groin hernia repairs in Sweden. The large database enables assessment of the relative risks for CPIP depending on in particular mesh and mesh fixation, adjusted for other plausible risk factors.

Each participant was entered at the date of surgery, when demographic and intraoperative data were registered. One year postop, each patient was sent a questionnaire focusing on present pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All Lichtenstein and similar open mesh repairs that have been registered in the SHR from September 1, 2012, until December 31, 2018.

Exclusion criteria

  • Laparoscopic repairs.
  • Preperitoneal open repairs.
  • Pure suture repairs
  • Patients not having a 10-digit state-assigned Patient Identification Number.

Treatment and study plan

Lichtenstein mesh repair

Device

A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures

Primary outcomes

  1. CPIP

    Time frame: 1 year

    Chronic postoperative inguinal pain

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Swedish Hernia Registry
  • Uppsala University

Registry information

Official study title

Mesh and Fixation Combinations in the Lichtenstein Groin Hernioplasty: Association With Chronic Postoperative Pain. A Swedish Hernia Registry Study.

Important dates

Study start
2012
Primary completion
2019
Study completion
2020
First posted
Apr 9, 2021
Registry last updated
Dec 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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